A clinical trial of the value of a tomographic section view to identify liver abnormalities by radionuclide imaging with special reference to metastatic disease

1981 ◽  
Vol 6 (2) ◽  
Author(s):  
P.P. Dendy ◽  
W.I. Keyes ◽  
Anne Reid ◽  
P.E. Undrill ◽  
F.W. Smith ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Special Reference ◽  
Radionuclide Imaging ◽  
Metastatic Disease ◽  
Tomographic Section

scholarly journals Spinal intraarterial chemotherapy: interim results of a Phase I clinical trial

2016 ◽  
Vol 24 (2) ◽  
pp. 217-222 ◽  
Author(s):  
Athos Patsalides ◽  
Yoshiya Yamada ◽  
Mark Bilsky ◽  
Eric Lis ◽  
Ilya Laufer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
Phase I ◽  
Metastatic Disease ◽  
Spinal Metastases ◽  
Cord Compression ◽  
Local Tumor Control ◽  
Phase I Clinical Trial ◽  
Intraarterial Chemotherapy ◽  
Tumor Control

OBJECT Despite advances in therapies using radiation oncology and spinal oncological surgery, there is a subgroup of patients with spinal metastases who suffer from progressive or recurrent epidural disease and remain at risk for neurological compromise. In this paper the authors describe their initial experience with a novel therapeutic approach that consists of intraarterial (IA) infusion of chemotherapy to treat progressive spinal metastatic disease. METHODS The main inclusion criterion was the presence of progressive, metastatic epidural disease to the spine causing spinal canal compromise in patients who were not candidates for the standard treatments of radiation therapy and/or surgery. All tumor histological types were eligible for this trial. Using the transfemoral arterial approach and standard neurointerventional techniques, all patients were treated with IA infusion of melphalan in the arteries supplying the epidural tumor. The protocol allowed for up to 3 procedures repeated at 3- to 6-week intervals. Outcome measures included physiological measures: 1) periprocedural complications according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events; and 2) MRI to assess for tumor response. RESULTS Nine patients with progressive spinal metastatic disease and cord compression were enrolled in a Phase I clinical trial of selective IA chemotherapy. All patients had metastatic disease from solid organs and were not candidates for further radiation therapy or surgery. A total of 19 spinal intraarterial chemotherapy (SIAC) procedures were performed, and the follow-up period ranged from 1 to 7 months (median 3 months). There was 1 serious adverse event (febrile neutropenia). Local tumor control was seen in 8 of 9 patients, whereas tumor progression at the treated level was seen in 1 patient. CONCLUSIONS These preliminary results support the hypothesis that SIAC is feasible and safe.

Clinical outcomes of patients enrolled in clinical trial compared with patients outside clinical trial in advanced gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 21-21
Author(s):  
Jaejoon Han ◽  
Jin Won Kim ◽  
Se Hyun Kim ◽  
Jeong-Ok Lee ◽  
Yu Jung Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Metastatic Disease ◽  
Median Overall Survival ◽  
Phase 1 ◽  
Second Line ◽  
First Line ◽  
Better Than

21 Background: Participation in clinical trials gives patients with cancer a chance to receive potential benefits, such as experimental treatment, meticulous follow-up and toxicity managements. We aimed to assess the evidence that such an effect exists in patients with gastric cancer. Methods: Clinical characteristics and overall survival of patients with metastatic or recurrent gastric cancer who received fluoropyrimidine and platinum combination palliative chemotherapy within or outside clinical trials at tertiary referral hospital from January 2010 to December 2012 were retrospectively analyzed. Results: Of the 244 patients, 84 patients (34%) were enrolled in clinical trials. During the study period, 20 patients in four phase 3 trials, 54 patients in eight phase 2 trials and ten patients in two phase 1 trials were participated in clinical trials. Twenty patients (8%) at first-line and 64 patients (38%) at second-line or later were enrolled in clinical trials. Younger age (P = 0.014), metastatic disease (P = 0.015) and HER2 IHC status (P = 0.005) were correlated with participation in clinical trials. The median overall survival of patients who participated in clinical trials at first-line was better than those who did not participated in clinical trials, although it was not statistically significant (16 months and 11 months, respectively, P = 0.407). Number of participation in clinical trials was not associated with survival outcome (1 versus ≥ 2 trials: 15 months and 18 months, respectively, P = 0.545). Second-line chemotherapy was administered in 167 patients. The median overall survival of patients who participated in clinical trials at second-line or later was also better than those who did not participated in clinical trials, however, it was not statistically significant (9 months and 6 months, respectively, P = 0.101). Conclusions: Younger patients, metastatic disease, positive HER2 IHC status, and clinical setting of second-line or later were associated with more participation in clinical trials. The median overall survival was numerically longer in patients who were enrolled in the clinical trials although it was not statistically significant.

scholarly journals “Management of Shweta Pradara with local application of Palashadi Yoga with special reference to Abnormal Vaginal Discharge”

The Healer ◽  
2021 ◽  
Vol 2 (02) ◽  
pp. 1-8
Author(s):  
Subhadra Karki ◽  
Anupam Tamrakar ◽  
Sharma Sushila
Keyword(s):  
Clinical Trial ◽  
Tract Infection ◽  
Special Reference ◽  
Simple Form ◽  
Genital Tract ◽  
Vaginal Discharge ◽  
Local Application ◽  
Lower Abdomen ◽  
Abnormal Vaginal Discharge ◽  
Effective Remedy

Women are always prone to several forms of infection in their genital tract.It ranges from simple form of infectious discharges to malignant conditions in the genital tract. The infectious types of discharge though appear to be a simple form it can be the start of bigger problems in future if left untreated.The tract infection is also important for the fact that it is a most useful part in process of progeny continuation. So, to find out an effective remedy in Ayurveda Palashadi Yoga was selected.15 patients were selected randomly for present clinical trial study. Highly significant results were observed in discharge per vagina and pain in lower abdomen.

scholarly journals Revisiting a null hypothesis: exploring the parameters of oligometastasis treatment

2020 ◽  
Author(s):  
Jessica A. Scaborough ◽  
Martin C. Tom ◽  
Michael W. Kattan ◽  
Jacob G. Scott
Keyword(s):  
Clinical Trial ◽  
Tumor Growth ◽  
Metastatic Disease ◽  
Null Hypothesis ◽  
Treatment Time ◽  
Metastatic Cancer ◽  
Clinical Trial Design ◽  
Simple Formulation ◽  
Metastatic Lesions ◽  
Overall Survival Benefit

In the treatment of patients with metastatic cancer, the current paradigm states that metastasis-directed therapy does not prolong life. This paradigm forms the basis of clinical trial null hypotheses, where trials are built to test the null hypothesis: patients garner no overall survival benefit from targeting metastatic lesions. However, with advancing imaging technology and increasingly precise techniques for targeting lesions, a much larger proportion of metastatic disease can be treated. As a result, the life-extending benefit of targeting metastatic disease is becoming increasingly clear. In this work, we suggest shifting this qualitative null hypothesis, and describe a mathematical model which can be used to frame a new, quantitative null. We begin with a very simple formulation of tumor growth, an exponential function, and illustrate how the same intervention (removing a given number of cells from the tumor) at different times effects survival. Additionally, we postulate where recent clinical trials fit into this parameter space and discuss the implications of clinical trial design in changing these quantitative parameters. Our model shows that while any amount of cell kill will extend survival, in many cases the extent is so small as to be unnoticeable in a clinical context or out-weighed by factors related to toxicity and treatment time. Recasting the null in these quantitative terms will allow trialists to design trials specifically to increase understanding of what circumstances (patient selection, disease burden, tumor growth kinetics) can lead to improved OS when targeting metastatic lesions, rather than whether or not targeting metastases extends survival for patients with (oligo-)metastatic disease.

Immunologic impact of anti-CTLA-4 therapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 3019-3019
Author(s):  
P. Sharma ◽  
D. Tsavachidou ◽  
A. Kamat ◽  
D. Ng Tang ◽  
H. Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
T Cells ◽  
T Cell ◽  
Immune Responses ◽  
Metastatic Disease ◽  
Cd4 T Cells ◽  
Cell Function ◽  
Cytotoxic T Lymphocyte ◽  
Systemic Circulation ◽  
Tumor Tissues

3019 Background: Blockade of the T-cell inhibitory molecule known as cytotoxic T lymphocyte antigen-4 (CTLA-4) results in antitumor responses. To date, trials have been conducted with over 4,000 patients with various malignancies in the metastatic disease setting, which allow for correlation of therapy with clinical outcome but do not provide analyses of relevant biomarkers in the systemic circulation that reflect changes within the tumor microenvironment. Approximately 10% of treated patients respond to therapy. Why some patients respond while others do not remains unknown. The identification of intermediate biomarkers are essential for us to understand whether anti-CTLA-4 antibody has “hit its target” to affect human immune responses and whether these identified immune responses can serve as predictive markers of clinical outcomes. Methods: We conducted a presurgical clinical trial with anti-CTLA-4 antibody. Patients with localized bladder cancer (N=10) were given two doses of antibody prior to undergoing surgery. Immunological analyses were conducted on patients’ tissues and blood samples. Results: Expression of the inducible costimulator (ICOS) molecule was increased on CD4 T cells within tumor tissues and systemic circulation. ICOS-expressing T-cells have not previously been reported to have a role in anti-tumor responses. We showed that CD4+ICOShi T cells produced IFNγ and could recognize the NY-ESO-1 tumor antigen. Pre- and post-therapy CD4 T cells were analyzed by reverse-phase protein array and microRNA array, which led to the identification of signaling pathways and regulatory mechanisms that play a role in enhanced T-cell function. Furthermore, murine models confirmed our initial findings and implied a role for ICOS-expressing T-cells in antitumor responses. Finally, we extended our findings to the metastatic disease setting of melanoma patients (N=14) and our preliminary data indicate an improved survival for anti-CTLA-4 treated patients who have a sustained increase in ICOS-expressing CD4 T cells. Conclusions: Our presurgical clinical trial allowed for the correlation of data from tumor tissues with data from peripheral blood, thus identifying ICOS-expressing T-cells as a relevant biomarker that can be used to monitor patients who receive anti-CTLA-4 therapy. [Table: see text]

AN AMELIORATE COMPARATIVE CLINICAL TRIAL OF NAVAYAS LOUHA SYRUP AND NISHA LOUHA SYRUP IN THE MANAGEMENT OF PANDU ROGA WITH SPECIAL REFERENCE TO IRON DEFICIENCY ANEMIA IN CHILDREN

2021 ◽  
Vol 12 (4) ◽  
pp. 56-61
Author(s):  
Bharti Tiwari ◽  
Amar Singh Tiwari ◽  
Satish Chand Gupta
Keyword(s):  
Clinical Trial ◽  
Iron Deficiency ◽  
Special Reference ◽  
Iron Deficiency Anemia ◽  
Clinical Efficacy ◽  
Health Problem ◽  
Deficiency Anemia ◽  
Indian Children ◽  
Major Health Problem ◽  
Comparative Clinical Trial

Anemia is a major health problem in India. Yet, a comprehensive plan of action to combat this public health problem has been still missing. There are few existing plans for the control of Iron Deficiency Anemia regarding children and pregnant women and lactating mothers. Iron deficiency is the result of long-term negative iron balance. Iron deficiency anemia (IDA) should be regarded as a subset of iron deficiency, that is, it represents the extreme lower end of the distribution of iron deficiency. Treatment options include oral and intravenous iron therapy; however, the efficacy of oral iron is limited in certain gastrointestinal conditions, such as inflammatory bowel disease, celiac disease, and autoimmune gastritis. So that ameliorate comparative clinical trial was taken with Ayurveda formulation for the diagnosis and treatment of iron deficiency anemia (IDA) with special reference to Pandu Roga. Overall, in the study Navayas Louha was found to have 76.53% and of Nisha Louha was found to have 69.33% clinical efficacy. The study showed that trial clinical efficacy of Navayas Louha syrup is better than Nisha Louha syrup in the management of iron deficiency anemia in Indian children.

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