Effect of Ark malahara in Vicharchika- A clinical study

2020 ◽  
Vol 6 (2) ◽  
pp. 50-54
Author(s):  
Suman Purohit ◽  
◽  
Shweta Shukla ◽  
Khemchand Sharma ◽  
◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Medical Practice ◽  
Satisfactory Treatment ◽  
Clinical Presentations

Vicharchika (Eczema) is a type of kshudrakustha characterized with symptoms, namely, kandu, Srava, Pidaka and Shyavata and Pidikotpatti. Vicharchika is often correlated to eczema based on the clinical presentations. No satisfactory treatment is available in contemporary medical practice. In Ayurveda variousformulations are mentioned for treatment of Vicharchika. In the present study a clinical trial was done using Ark Malahara in 15 patients of either sex in between the age of 20 to 70 years. Highly significant result is obtained in Kandu, while significant result was obtained in Daha, Srava, Pidika, Rukshta, Vaivarnya.

scholarly journals Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Study ◽  
Primary Source ◽  
European Medicines Agency ◽  
Clinical Trial Registries ◽  
Number Of Patients ◽  
Journal Publications ◽  
Clinical Study Reports ◽  
Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

scholarly journals Infra-Zygomatic Mini Screws Compared to High Pull Headgear for Distalization And Intrusion of Maxillary Molars in Growing Patients with Class II Malocclusion: A Randomized Clinical Trial

2021 ◽  
Vol 2 (1) ◽  
pp. 14-19
Author(s):  
Ahmed K. Afify ◽  
Amr E. El-Dakroury ◽  
Sherif A. El-Kordy ◽  
Mostafa M. El-Dawlatly
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Treatment Duration ◽  
Class Ii ◽  
Class Ii Malocclusion ◽  
Maxillary Molars ◽  
Randomized Clinical Study ◽  
Molar Intrusion ◽  
Before And After ◽  
Patient Cooperation

Objective: The aim of the present randomized clinical study was to evaluate the distalization and intrusion effect of an Infra-zygomatic mini-screws supported appliance and compare it with high pull headgear appliance in treatment of growing patients with class II malocclusion. Methodology: 22 growing boys aged between (10 to 12 years) with class II div 1 malocclusion randomly divided to 2 equal groups. The first group treated with high pull headgear with acrylic splint and the second one treated with an Infra-zygomatic mini-screws supported appliance. The treatment duration was 8 months for both groups. Lateral cephalometric radiographs were taken before and after the treatment for each patient to be analyzed. Results: The maxillary first molar distalization was 2.58±2.31 mm in head gear group and 1.53±2.83 mm in mini-screws group. There was no significant maxillary first molar intrusion in both groups. There were no significant differences between the two groups. Conclusions: the mini-screws supported appliance can be used as the fixed replacement of the removable high pull headgear appliance with no need for patient cooperation.

Combining radiation therapy with anti-PD-1 for patients with advanced hepatocellular carcinoma: An open-label, single-center, single-arm clinical study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16117-e16117
Author(s):  
Jian-Xu Li ◽  
Ting-Shi Su ◽  
Xiao-Feng Lin ◽  
Yi-Tian Chen ◽  
Shi-Xiong Liang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
Clinical Study ◽  
Cancer Staging ◽  
Advanced Hepatocellular Carcinoma ◽  
Single Center ◽  
Open Label ◽  
Grade 3 ◽  
Clinical Trial Information

e16117 Combining radiation therapy with anti-PD-1 for patients with advanced hepatocellular carcinoma: an open-label, single-center, single-arm clinical study Jian-Xu Li, Ting-Shi Su, Xiao-Feng Lin, Yi-Tian Chen, Shi-Xiong Liang, Bang-De Xiang; Guangxi Medical University Cancer Hospital, Nanning, China Abstract Research Funding: Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. Guangxi Medical and Health Appropriate Technology Development and Application Project (No. S2019039), Guangxi, China. Background: Based on the results of recent studies, the PD-1 monoclonal antibodies have been approved to treat the patients with advanced hepatocellular carcinoma (HCC) by the FDA. Radiation therapy (RT) can enhance responsiveness to PD-1 monoclonal antibody by potential mechanisms. A phase Ⅱa study was conducted to assess the safety and the efficacy of combining RT with anti-PD-1 for patients with advanced hepatocellular carcinoma. Methods: Patients with advanced HCC were eligible. Stereotactic body radiation therapy (SBRT) were adopted, and the dose of radiation were Dt-PGTV 30-50 Gy/10fractions. Camrelizumab (200mg) were given intravenously every 3 weeks since the first day of RT until disease progression, or intolerable toxicity. Adverse events (AEs) and objective response rate (ORR) were summarized to assess the safety and efficacy. Results: From April 2020 to November 2020, 17 patients were enrolled (median age 54, range 32-69). 15 (88%) patients were male. 14 (82%) had ECOG performance score of 0. All the patients had Child-Pugh score A. 16 patients staged as Barcelona Clinic Liver Cancer staging C or China Liver Cancer staging Ⅲ. Extrahepatic metastases were identified in 11 (65%) patients. 13 (77%) patients were Hepatitis B virus infected. 15 (88%) patients had previously 2 lines or more chemotherapy. 9 (53%) patients had Alpha-fetoprotein level≥400 ng/ml. The ORR was 47%. The best response assessed by RECIST 1.1 was partial response (8 patients). Four patients had grade 3 immune-related adverse events (irAEs), including increased aspartate aminotransferase and alanine transaminase (n =1)，decreased hemoglobin (n =1)，decreased platelet count (n =1)，decreased neutrophil count (n =1). All grade 3 irAEs were mitigated with proper treatment. None treatment-related deaths occurred. Conclusions: In this study, RT combined with anti-PD-1 had an acceptable safety profile and indicated an effective treatment option in patients with unresectable HCC. Clinical trial information: NCT04193696. Clinical trial information: NCT04193696.

NCOG-27. STATUS AS A CLINICAL TRIAL PARTICIPANT AND OUTCOME IN IDH-WILDTYPE GLIOBLASTOMA

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi157-vi158
Author(s):  
Peter Pan ◽  
Adela Joanta-Gomez ◽  
Fabio Iwamoto ◽  
Mary Welch ◽  
Aya Haggiagi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Promoter Methylation ◽  
Parietal Lobe ◽  
Strong Predictor ◽  
Standard Of Care ◽  
Mgmt Promoter Methylation ◽  
Study Patient ◽  
Trial Participant ◽  
Mgmt Promoter

Abstract INTRODUCTION Standard of care for glioblastoma consists of surgery, followed by combined chemoradiation and adjuvant chemotherapy, as per the seminal EORTC study from 2005. Clinical trial patients, being a population selected for functional status, hepatic function, renal function, and lack of other malignancies, may have improved outcome over the general treated population. METHOD Single center retrospective analysis of status as a clinical trial patient in the upfront setting and other clinical factors/biomarkers, analyzed for correlation with outcomes (PFS/OS) in IDH-wildtype glioblastomas. RESULTS 82 patients with IDH-wildtype glioblastoma were identified between 2014 and 2020, treated with standard of care or with an upfront clinical study (43% women; median age 66 years, range 35-91 years of age). 22 patients (27%) were treated with upfront clinical study. Status as a patient treated in an upfront clinical study did not correlate with outcome (hazard ratio HR PFS 0.99, CI 0.57-1.7, p=0.97; HR OS 1.09, CI 0.56-2.1, p=0.81). Frontal lobe was most frequently involved (n=36, 44%), followed by parietal lobe (n=33, 40%). Age was not a strong predictor of survival (R2 0.01). No statistically significant correlation was observed between outcome and laterality or location. MGMT promoter methylation was associated with improved PFS (HR 0.56, CI 0.33-0.94, p=0.03) and OS (HR 0.40, CI 0.19-0.85, p=0.02), with mPFS 6 months vs 9 months and mOS 16 months vs 20 months (unmethylated vs methylated respectively). CONCLUSION In this retrospective cohort of IDH-wildtype glioblastomas, age, tumor laterality, and tumor location were not significant predictors of outcome. MGMT promoter methylation predicted for superior PFS/OS. Patient selection for clinical studies are influenced by entry criteria, however at least in this retrospective review, status as a clinical study patient in the upfront setting did not correlate with outcome compared to patients treated with upfront standard of care.

scholarly journals Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Anna Hansson ◽  
Thomas Rasmussen ◽  
Roland Perfekt ◽  
Elin Hall ◽  
Holger Kraiczi
Keyword(s):  
Clinical Trial ◽  
Smoking Cessation ◽  
Clinical Study ◽  
Visual Analogue Scale ◽  
Replacement Therapy ◽  
Success Rate ◽  
Analogue Scale ◽  
Healthy Adult ◽  
Nicotine Gum ◽  
Search Query

Abstract Background Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Thus, this study was performed to compare relief of urges to smoke, up until 5 h following treatment with a new 6 mg nicotine gum versus currently marketed 4 mg nicotine gum. Methods This was a randomized crossover clinical study. Following 12 h of abstinence from smoking, either one 6 mg or one 4 mg nicotine gum was given to 240 healthy adult smokers. Thereafter, urges to smoke were scored on a 100 mm Visual Analogue Scale repeatedly over 5 h. Results The reductions in urges to smoke over the first 1 and 3 h after administration were statistically significantly greater with 6 mg than 4 mg gum, (p < 0.005). A 50% reduction in perceived urges to smoke was reached in 9.4 min with 6 mg gum compared to 16.2 min with 4 mg gum (median values). The median duration of a 50% or more reduction in VAS urges to smoke score was 111 min with the 6 mg gum, versus 74 min for the 4 mg gum. Conclusion This study provides evidence that the 6 mg nicotine gum provided a greater reduction, faster and longer relief of urges to smoke than the 4 mg nicotine gum. Trial registration EudraCT Number: 2010–023268-42. Study was first entered in EudraCT 2011-02-23.

scholarly journals The Effect of Korean Red Ginseng on Sexual Function in Premenopausal Women: Placebo-Controlled, Double-Blind, Crossover Clinical Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Ho Seok Chung ◽  
Insang Hwang ◽  
Kyung Jin Oh ◽  
Mi Na Lee ◽  
Kwangsung Park
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Sexual Dysfunction ◽  
Sexual Function ◽  
Premenopausal Women ◽  
Placebo Treatment ◽  
Female Sexual Function ◽  
Red Ginseng ◽  
Korean Red Ginseng ◽  
Double Blind

This study investigated whether Korean red ginseng (KRG) extracts could improve sexual function in premenopausal women. Forty-one premenopausal women participated in this placebo-controlled, double-blind, and crossover clinical study with administration of either three ginseng capsules (1 g per capsule) or placebo daily. After 8 weeks of medication of KRG or placebo, medication was changed for the subjects to placebo or KRG after 2 weeks of washout period. The efficacy of KRG extracts was measured by using Female Sexual Function Index (FSFI).Results. Twenty-three women completed the study. Total FSFI scores increased after KRG treatment (from20.13±2.87to23.98±4.10,p=0.015) and placebo treatment (from20.06±2.64to23.78±3.28,p=0.003). However, this change was not significantly different between the two groups (p=0.702). KRG treatment significantly improved sexual desire, arousal, orgasm, and satisfaction domains; however, there was no treatment effect compared with placebo. There was a case of gastric discomfort after taking KRG extracts. Oral administration of KRG extracts improved sexual function in premenopausal women; however, there were no statistical significant changes compared to placebo. It implies that KRG extracts have a substantial placebo effect in premenopausal women with sexual dysfunction.

In Vivo Evaluation of Immunomodulating Effects of Lenalidomide (L) on Tumor Cell Microenvironment as a Possible Underlying Mechanism of the Antitumor Effects Observed in Patients (pts) with Chronic Lymphocytic Leukemia (CLL).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2975-2975 ◽  
Author(s):  
Asher Alban Chanan-Khan ◽  
Swaminathan Padmanabhan ◽  
Kena C. Miller ◽  
Paula Pera ◽  
Laurie DiMiceli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Tumor Microenvironment ◽  
Antitumor Activity ◽  
Immune Cell ◽  
Underlying Mechanism ◽  
Antitumor Effects ◽  
Absolute Increase

Abstract Introduction: L is a more potent analogue of thalidomide with antitumor activity reported in MDS and multiple myeloma. Clinical anti-leukemic activity of L is reported for the first time by our group in pts with CLL. The underlying mechanism of its antitumor activity remains undetermined. We investigated the effect of L on the tumor microenvironment and studied the modulation of soluble cytokines and immune cells (T and NK cells) in pts receiving L. Patients and Methods: CLL pts enrolled on the clinical study with L were eligible. Pre and post (day 7) samples were obtained for evaluation of changes in serum cytokine and immune cell environment. Malignant cells were also obtained to investigate the in vitro antitumor activity of L prior to initiating treatment on clinical trial. Results: With Anexin V staining for evaluation of apoptosis induction, in vitro testing of pts samples (n=10) showed only a modest increase in apoptosis at 200mg of L - levels clinically not achievable. Yet same pts treated with L on clinical study showed significant antitumor response, suggesting the mechanism to be possibly related to modulation of the tumor microenvironment. In evaluation of the tumor cytokine microenvironment (n= 10) we noted significant L induced increase in IL-10 (n=6), IL-8 (n=8), IP-10 (n=10), IL-8 (n=8), TNF-alpha (n=4) and decrease in PDGF (n=5) and RANTES (n=5). While evaluation of the immune cell repertoire we observed an absolute increase in T-cell as well as NK-cell after treatment with L. Conclusion: Our in vitro evaluation does not suggest a direct apoptotic effect of L on the malignant CLL cells and thus support the hypothesis that the anti-leukemic effect noted in the clinical trial (reported separately) is most likely from in vivo modulation of the tumor microenvironment as is demonstrated from changes in the cytokine milieu and the cellular immune response. Collectively these changes may be responsible for the immune modulating properties of L and the resultant anti-CLL activity in pts.

Rare ovarian tumors (ROT). Impact of an interactive website on medical practice and inclusions in a clinical trial. Results after 1 year

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 5110-5110 ◽  
Author(s):  
I. Ray-Coquard ◽  
P. Cassier ◽  
I. Treilleux ◽  
J.-P. Lotz ◽  
C. Tournigand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Medical Practice ◽  
Ovarian Tumors ◽  
Clinical Trial Results
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