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Behavioral/Epidemiological


National HIV Behavioral Surveillance (Miami-Dade County site)


Marlene LaLota, Lisa Metsch, David Forrest, Dano Beck


Behavioral studies

Behavioral surveillance among high-risk populations (i.e., MSM, IDUs, and heterosexuals at increased risk for infection). This ongoing study was first implemented in 2004. Each population is sampled approximately once every three years; two study cycles have been completed among each population. The study provides data on 1) trends in sexual and drug-use risk behaviors, 2) HIV prevalence and incidence, 3) HIV testing patterns, and 4) the use and impact of prevention services. The overarching goal of NHBS is to help evaluate and direct local and national prevention efforts

University of Florida Center for HIV/AIDS Research Education and Service (UF CARES) – 11 Studies

Presented by Mobeen Rathore, M.D.



Behavioral/Epidemiological


Calcium, Vitamin D and bone mineral density in HIV infected children compared to normal age and sex matched subjects (planning ongoing)

Saran Valdez- Johnson MD, Ayesha Mirza MD

Pediatrics

HIV and children and adolescents


Behavioral/Epidemiological


Dyslipidemia in HIV infected children on HAART (ongoing)


Ayesha Mirza, Peter Wludyka, Mobeen Rathore

Pediatrics

Metabolic complications in HIV and children

Behavioral/Epidemiological


Analysis of perinatal HIV transmission in Florida 2002-2009 (completed)



Ayesha Mirza, N Harrell, M Lalota, L Maddox, Mobeen Rathore

UF Pediatrics and DOH, Bureau of HIV/AIDS

Perinatal HIV transmission

Behavioral/Epidemiological


Longitudinal Epidemiologic Study to Gain Insight Into HIV/AIDS In Children & Youth (legacy)

Mobeen Rathore, MD

Pediatrics

HIV

Behavioral/Epidemiological


P1074: A Prospective Surveillance Study of Long-Term Outcomes in HIV-infected Infants, Children & Adolescents, Version 1.0 dated February 2, 2009 The IRB has determined the risk/benefit for this study is consistent with 45 CFR 45.404

Mobeen Rathore, MD

Pediatrics

HIV, long-term outcomes, chart review

Behavioral/Epidemiological


PACTG P1055: Psychiatric Co-Morbidity in Perinatally HIV-Infected Children & Adolescents

Mobeen Rathore, MD

Pediatrics

HIV, children, Psychiatric

Behavioral/Epidemiological


Evaluation of Lipid Profiles on HIV Infected Patients on HAART

Mobeen Rathore, MD

Pediatrics

Lipid disorders, HIV infection, serum cholesterol

Behavioral/Epidemiological


Improving Hepatitis C testing compliance among infants born to Hepatitis C and HIV infected mothers

Mobeen Rathore, MD

Pediatrics




Behavioral/Epidemiological


Perinatal Core Protocol, PACTG 1025 Includes Substudy: IMPAACT P1026s: Pharmacokinetic Properties of Antiretroviral Drugs During Pregnancy

Mobeen Rathore, MD

Pediatrics

HIV

Behavioral/Epidemiological


Surveillance Monitoring for ART Toxicities Study in HIV-uninfected Children Born to HIV-infected Women (SMARTT study) (PH100)

Mobeen Rathore, MD

Pediatrics

HIV

Behavioral/Epidemiological


The Antiretroviral Pregnancy Registry


Isaac Delke, MD

Pediatrics

HIV, antiretrovirals

Broward Children’s Diagnostic & Treatment Center - 13 Studies

Presented by Ana Puga, M.D.



Behavioral/Epidemiological


ATN 071/101: Neurocognitive Assessment in Youth Initiating Highly Active Antiretroviral Therapy (HAART)(recruiting 101 only)

Ana Puga, MD

Doyle Patton, PhD



CFAP Research

Neurocognitive impact of HIV in youth

Behavioral/Epidemiological


ATN 078: A Pilot Study Using Cell Phone Interactions to Improve Medication Adherence in Adolescents Who Have Previously Failed Antiretroviral therapy due to Non-Adherence. (on-going)

Ana Puga, MD

CFAP Research

Adherence in youth

Behavioral/Epidemiological


ATN 093: Evaluation of Strategic Multisite Initiative for the Identification, Linkage, and Engagement (SMILE) in Care of Youth (recruiting)

Ana Puga, MD

Marie Hayes, MSW



CFAP Research

Youth Linkage to Care Study

Behavioral/Epidemiological


ATN 096: Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescentn and Young Adults (recruiting)

Ana Puga, MD

CFAP Research

HIV Testing

Behavioral/Epidemiological


IMPAACT 1074: A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents (recruiting)

Ana Puga, MD

CFAP Research

Prospective long term follow-up of Children/Youth on Highly Active Antiretroviral Therapy (HAART)

Behavioral/Epidemiological


IMPAACT P1080: A Pilot Study of Psychiatric and Antiretroviral Medication Concentrations in HIV-1 Infected and Uninfected Children and Adolescents (recruiting)

Ana Puga, MD

CFAP Research

Psychiatric medications and antiretroviral medication pharmacokinetics

Behavioral/Epidemiological

Basic Science/Virology




IMPAACT P1085 : Duration of Human Papilloma Virus (HPV) Type-Specific Antibody After Administration of Quadrivalent HPV Vaccine to HIV-1 Infected Children Preciously Enrolled in IMPAACT P1047 (recruiting)

Ana Puga, MD

CFAP Research

Duration of HPV antibodies post-vaccination

Behavioral/Epidemiological


PACTG 1025: Perinatal Core Protocol (recruiting)

Ana Puga, MD

CFAP Research

Perinatal Observational Study

Behavioral/Epidemiological


PH 201 AMP Memory Study: Memory Functioning in Children and Adolescents with Perinatal HIV Infection (recruiting)

Ana Puga, MD

CFAP Research

Neuropsychology and HIV in Children

Behavioral/Epidemiological


PH100 SMARTT: PHACS 100: Surveillance Monitoring for ART Toxicities in HIV-uninfected Children Born to HIV-infected Women (SMARTT Study).
Version change includes SMARTT Reference Cohort Sub Study and SMARTT Nutrition Sub Study (recruiting)


Ana Puga, MD

CFAP Research

Antiretroviral (ART) toxicity monitoring in HIV exposed and infected infants

Behavioral/Epidemiological


PH100 SMARTT REFERENCE: A Study of the Effect of Maternal Health in Pregnancy on Health and Development of Infants and Children (recruiting)

Ana Puga, MD

CFAP Research

Unexposed control cohort for SMARTT

Behavioral/Epidemiological


PH200 AMP: PHACS 200: Adolescent Master Protocol (AMP). (recruiting)

Ana Puga, MD

CFAP Research

Long term follow-up of perinatally infected youth and perinatally HIV exposed youth

Behavioral/Epidemiological


SMARTT NUTRITION: SMARTT Nutrition Component (recruiting)

Ana Puga, MD

CFAP Research

Nutrition for HIV positive pregnant women

ClinicalTrials.gov Website Studies – 18 Additional Studies

Behavioral/Epidemiological


Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults

(Effectiveness of AVT strategy with SSNIT; Facilitators & barriers to HIV testing;   Sub-group differences)



Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Cherrie B. Boyer, Ph.D.,

Jonathan M. Ellen, M.D., Adolescent Trials Network


The proposed research will include adolescent and young adult Hispanic/Latino men who have sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial services to the target group. In 10 of the 13 sites, comparisons will be made between alternative venue-based testing (AVT) and social and sexual network-based interviewing and HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying undiagnosed HIV in our target group of adolescents and young adults. All study participants will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening. Participants with presumptive HIV positive screening results will be referred to the local AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical care. Linkage to care for ATN 096 study participants will be conducted in accordance with the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as part of this protocol are linked with treatment and care.

Clinical Trial

Behavioral/Epidemiological




Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women

National Institute of Allergy and Infectious Diseases (NIAID)
Sharon Nachman, MD, State University of New York at Stony Brook
Pfizer CT.gov Call Center

Adverse events (AEs) of all grades;   AEs of all grades attributed to the study vaccine;   Withholding of second vaccine dose due to adverse reactions attributed to first dose;   Immunologic response, defined as hemagglutination inhibition (HAI) titer of at least 1:40;   Maternal immunologic response, defined as HAI of at least 1:40;   Infant HAI of at least 1:40;   Maternal geometric mean titers (GMT) of antibodies HAI;   Infant GMT of antibodies HAI;   Maternal cell-mediated immunity (CMI) responses, as measured by B-cell and T-cell enzyme-linked immunosorbent spot (ELISPOT) assay values;   CD4 count;   HIV RNA copies/ml;   Response to seasonal trivalent influenza vaccine (TIV);   Exploration of factors related to HIV and its treatment that might affect the response to H1N1 vaccinations

Clinical Trial

Behavioral/Epidemiological




Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

National Institute of Allergy and Infectious Diseases (NIAID);   National Institute of Dental and Craniofacial Research (NIDCR)

Erna Milunka Kojic, MD, Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University;

Susan Cu-Uvin, MD, Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University


Type-specific HPV antibody development from the seronegative status at baseline to seropositive status a month after the completion of HPV vaccination series (Week 28) for HPV types 6, 11, 16, and 18;   Occurrence of Grade 3 or greater adverse events;   HPV antibody titers to types 6, 11, 16, 18;   Longitudinal changes in HIV viral load;   Nadir and baseline CD4 count;   Baseline HIV viral load;   Cellular immune response assay data from the subset of U.S. participants;   Longitudinal changes in CD4+ cell count from baseline

Behavioral/Epidemiological


Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons

GSK Clinical Trials

This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

Clinical Trial

Behavioral/Epidemiological




Pharmacokinetic Study of Anti-HIV Drugs During Pregnancy

National Institute of Allergy and Infectious Diseases (NIAID);   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Mark Mirochnick, MD, Boston Medical Center



The purpose of this study is to determine what doses of anti-HIV medications are appropriate for pregnant women.

Anti-HIV medication taken during pregnancy may control a woman's viral load and reduce the chance that the baby will become infected with HIV. Pregnant women may require different doses of anti-HIV drugs than women who are not pregnant. This study will use pharmacokinetic (PK) sampling to determine what doses of anti-HIV medications are best for HIV-infected pregnant women and their infants.



Behavioral/Epidemiological


A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects

Pfizer CT.gov Call Center

The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.

Clinical Trial

Behavioral/Epidemiological




An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251)

Pfizer CT.gov Call Center

This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.


Behavioral/Epidemiological


Strategic Timing of Antiretroviral Treatment (START)

University of Minnesota - Clinical and Translational Science Institute

To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their CD4+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.

To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.



Clinical Trial

Behavioral/Epidemiological




High Dose Chemotherapy With Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients (BMT CTN 0803)

Joseph Alvarnas, MD, City of Hope National Medical Center

Richard Ambinder, MD, Johns Hopkins Medical Institution

National Heart, Lung, and Blood Institute (NHLBI);   National Cancer Institute (NCI);   Blood and Marrow Transplant Clinical Trials Network


This study is a Phase II, multicenter trial assessing overall survival after autologous hematopoietic stem cell transplantation using a BEAM transplant regimen in lymphoma patients with HIV.


Clinical Trial

Behavioral/Epidemiological




Perinatal Core Protocol

(Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission)

Ruth Tuomala, MD,

Director of Obstetrics and Gynecology, Brigham and Women's Hospital; Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine

International Maternal Pediatric Adolescent AIDS Clinical Trials Group;   Nat’l Inst. of Allergy and Infectious Diseases (NIAID);   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children.

The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.



Behavioral/Epidemiological

Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of PI-Associated Increased LDL Cholesterol in HIV-Infected Children and Adolescents


Ann Melvin, MD, Seattle

Children's Hospital;

John Farley, MD,

University of Maryland at

Baltimore

International Maternal

Pediatric Adolescent AIDS

Clinical Trials Group;  

National Institute of

Allergy and Infectious

Diseases (NIAID);  

Eunice Kennedy Shriver

National Institute of

Child Health and Human

Development (NICHD)


Treatment of HIV with antiretroviral regimens that include protease inhibitors (PIs) frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with PIs has been associated with significant increases in cholesterol and triglycerides in HIV infected adults and children. The purpose of this study is to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV infected children receiving antiretroviral regimens containing at least one PI.


Behavioral/Epidemiological

Computer-Delivered Motivational Intervention to Prevent Adherence Problems Among Youth Newly Recommended for HIV Medications: Project MESA (Motivational Enhancement System for Adherence)

Sylvie Naar- King, PhD,

Adolescent Trials Network

Eunice Kennedy Shriver

National Institute of

Child Health and Human

Development (NICHD);  

National Institute on 

Drug Abuse (NIDA);  

National Institute of 

Mental Health (NIMH)




This is a two-phase study, consisting of the following plan:

Phase I - This is a pre-test of the feasibility and acceptability of the beta version of a computer-delivered intervention, Motivational Enhancement System for Adherence (MESA), as well as the control intervention Motivational Enhancement System for Health (MESH) at three selected AMTUs. Following analysis of the responses in Phase I and further modification of the intervention, Phase II will be initiated.

Phase II - This is a pilot, randomized, controlled trial (RCT) testing a two-session computer-delivered intervention, MESA, designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications, as well as an attention control, MESH, matched for dose and delivery format. Phase II is open to all 15 AMTUs.


Clinical Trial

Behavioral/Epidemiological




Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile

NCT00993148


Principal Investigator: Jose Castro, M.D.  (U of Miami);

Babafemi Taiwo, MD, Northwestern University

Pfizer
Tibotec, Inc


The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.

Behavioral/Epidemiological


Study to Test Meta-intervention to Increase Retention in HIV Prevention Counseling

(This may be a duplication – see Duval CHD on page 14 ±)


University of Illinois at Urbana-Champaign

Collaborators: Duval County Health Department


Dolores Albarracin, PhD
William Livingood, PhD, Duval CHD

Unfortunately, people most at risk for HIV are the least likely to enroll and remain in prevention programs. In our past work, we have learned how to increase enrollment in such programs among this group. We have identified and addressed previously ignored gender-specific and client self-validation issues that conventional interventions often leave not only uncontrolled, but often biased against participation. The present work will extend these methods from enrollment to retention.

We intend to recruit a sample of 656 at-risk participants through our collaboration with the Duval County, FL Health Department for our randomized, double-blind trial. Our study will investigate if a meta-intervention video designed for empowering participants as agents of their own change can increase the number of attended sessions relative to a control condition without such a video. This trial will also determine if a meta-intervention video addressing various emotional/social and instrumental benefits of an HIV-prevention-counseling intervention can also increase the number of attended sessions. These two factors will be crossed, and their effects on retention will be estimated for different genders and ethnicities. Effects on clients' attention to the return sessions as reported by the counselor will also be explored among participants who return.

We will also conduct mediator analyses for investigating if the meta-intervention has mediating influences on corresponding expectations about the return counseling session. As the inclusion of meta-cognitive measures can alter the efficacy of the intervention, half of the sample will receive measures immediately (0-10 minutes) after exposure to the meta-intervention, before attendance to the next session is registered. The other half will not complete these measures


Clinical Trial

Behavioral/Epidemiological




A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging
NCT00822120

M.D. Anderson Cancer

Center at Orlando

Recruiting

Orlando, Florida

Contact:

Julio J. Hajdenberg, MD    

321-841-7219        

Southwest Oncology Group National Cancer Institute (NCI)

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment.

PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.




Clinical Trial

Behavioral/Epidemiological




An International Observational Study to Characterize Adults Who Are Hospitalized With Complications of Influenza A – Pandemic H1N1 (H1N1v); NCT01056185

University of Minnesota – Clinical and Translational Science Institute

National Institute of Allergy and Infectious Diseases (NIAID)


National Institutes of Health (NIH)

Infectious Diseases Associates NW FL, PA

Pensacola, Florida, United States, 32504

Contact: Barbara He Wade, MD, FACP    

bwade@infectioncenter.com 850-476-3131

Principal Investigator: Barbara He Wade, MD, FACP            

The “flu” is a common disease and usually mild, but severe disease and death may occur. There are several types of flu viruses and they change over time. Recently, a new influenza A virus known commonly as swine flu or H1N1v has emerged. This flu has spread rapidly around the world. It is important to understand the course of illness for those who have H1N1v and the characteristics of people who do not do well. The investigators will also try to learn more about how different treatments and prior vaccination for the flu affects the course of the illness. Approximately 1,000 individuals will be enrolled in several countries around the world. The results of this study will be used to advise on the management of patients who are hospitalized with the flu.


Clinical Trial

Behavioral/Epidemiological




INSIGHT H1N1v Outpatient Study (FLU 002)

Official Title: An International Observational Study to Characterize Adults With Influenza A – Pandemic H1N1 (H1N1v); NCT01056354

University of Minnesota – Clinical and Translational Science Institute

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)


Infectious Diseases Associates NW FL, PA

Pensacola, Florida, United States, 32504

Contact: Barbara He Wade, MD, FACP    

bwade@infectioncenter.com 850-476-3131

Principal Investigator: Barbara He Wade, MD, FACP            

The "flu" is a common disease and usually mild but severe disease and deaths may occur. There are several types of flu viruses and they change over time. Recently, a new influenza A virus known commonly as swine flu or H1N1v has emerged. This flu has spread rapidly around the world. It is important to understand the course of illness for those who have H1N1v and the characteristics of people who do not do well. The investigators will also try to learn more about how different treatments and prior vaccination for the flu affect the course of the illness. Approximately 5,000 individuals with swine flu will be enrolled in several countries around the world.


Clinical Trial

Behavioral/Epidemiological




Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma

Official Title: Phase III Randomized Study Of Chimeric Antibody 14.18 (CH14.18) In High Risk Neuroblastoma Following Myeloablative Therapy And Autologous Stem Cell Rescue

NCT00026312

Numerous locations throughout Florida

Children's OncologyGroup;   National Cancer 

Institute (NCI)

Under 30 yrs old


Study Chair:

Alice L. Yu, MD, PHD

UC at San Diego (no contact information provided)

University of Florida Shands Cancer Center

Gainesville, Florida, United States, 32610-0232

Contact: Clinical Trials Office - University of Florida Shands Cancer C     888-254-7581
Several other study centers – please see study NCT00026312 at       http://clinicaltrials.gov/ct2/show/study/NCT00026312



RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy, interleukin-2, and sargramostim following stem cell transplantation in treating neuroblastoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without monoclonal antibody, interleukin-2, and sargramostim following stem cell transplantation in treating patients who have neuroblastoma


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