Adverse Reactions following Two Separate Intravascular Injections of Contrast Media in the Same Patient

1987 ◽  
Vol 28 (1) ◽  
pp. 93-97 ◽  
Author(s):  
E. E. Sogn ◽  
T. Ødegård ◽  
T. Haider ◽  
E. Andrew
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Contrast Media ◽  
Contrast Medium ◽  
Comparative Studies ◽  
Adverse Reactions ◽  
Northern Europe ◽  
Retrospective Design ◽  
Clinical Trial Program ◽  
Recurrence Frequency

Adverse reactions following contrast medium injections in 26 non-comparative and parallel trials were extracted from the iohexol vascular clinical trial program in Northern Europe. Six hundred and forty-one patients (13–88 years old) in whom information was available about a vascular contrast medium examination before the iohexol clinical trials were included, enabling a retrospective within patient comparison of adverse reactions. Iohexol gave a lower recurrence frequency (approximately 3.5 times) of reactions than ionic monomers in patients who previously experienced adverse reactions to vascular contrast media. In order to overcome some of the drawbacks with the present retrospective design, prospective comparative studies are recommended.

scholarly journals SO093LONGITUDINAL DATA ON TREATMENT DURATION AND COMPLIANCE FROM AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE CLINICAL TRIALS WITH TOLVAPTAN

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Xiaolei Zhou ◽  
Diana Garbinsky ◽  
John Ouyang ◽  
Eric Davenport ◽  
Indra Agarwal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Treatment Duration ◽  
Treatment Time ◽  
Treatment Compliance ◽  
Kidney Volume ◽  
Total Kidney Volume ◽  
Treatment Gaps ◽  
Clinical Trial Program

Abstract Background and Aims : Observation of impactful clinical outcomes in a clinical trial setting for ADPKD is challenging due to the life-long progressive nature of ADPKD and longer-term associated outcomes of interest in this population (e.g., renal function decline, cardiovascular events, and mortality). Since 2004, the tolvaptan (TOL) clinical trial program enrolled subjects in multiple clinical studies with the opportunity to enroll in subsequent clinical trials for treatment and outcomes evaluation. Method : Data from 6 ADPKD studies (protocols 156-04-250, 156-04-251, 156-06-260, 156-09-284, 156-09-290, 156-08-271) were pooled and evaluated over time for overall treatment duration, treatment time, and treatment gaps. Treatment duration for the individual clinical trials ranged from 1 week to up to 3 years. Results : Overall, 1,437 subjects received TOL in these ADPKD clinical trials. For these subjects, the mean overall treatment duration was 4.1 years (3.8 years on treatment) with a maximum of 9.7 years (9.0 years on treatment). In this cohort, 513 subjects (35.7%) received TOL treatment for more than 5 years. Mean treatment compliance was 94.1%. Overall, 723 subjects (50.3%) received TOL treatment in ≥2 trials, with a median treatment gap duration between trials of 0.1 years (maximum, 5.6 years). At least 7 years of follow-up data are available for estimated glomerular filtration rate in 241 subjects (mean at baseline, 78.6 mL/min/1.73m2) and for total kidney volume in 130 subjects (mean at baseline, 1,816.9 mL). Conclusion : This analysis provides longitudinal follow-up over an extended timeframe in a large number of subjects treated with TOL, with the greatest number of subjects being enrolled in clinical trials enriched for rapidly progressing ADPKD. Treatment compliance over years was reasonably good despite treatment gaps.

Adaptive Learning of Drug Quality and Optimization of Patient Recruitment for Clinical Trials with Dropouts

2021 ◽  
Author(s):  
Zhili Tian ◽  
Weidong Han ◽  
Warren B. Powell
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Dynamic Programming ◽  
Value Function ◽  
Standard Treatment ◽  
Treatment Effectiveness ◽  
Interim Analyses ◽  
Clinical Trial Program ◽  
Patient Enrollment ◽  
The Value Function

Problem definition: Clinical trials are crucial to new drug development. This study investigates optimal patient enrollment in clinical trials with interim analyses, which are analyses of treatment responses from patients at intermediate points. Our model considers uncertainties in patient enrollment and drug treatment effectiveness. We consider the benefits of completing a trial early and the cost of accelerating a trial by maximizing the net present value of drug cumulative profit. Academic/practical relevance: Clinical trials frequently account for the largest cost in drug development, and patient enrollment is an important problem in trial management. Our study develops a dynamic program, accurately capturing the dynamics of the problem, to optimize patient enrollment while learning the treatment effectiveness of an investigated drug. Methodology: The model explicitly captures both the physical state (enrolled patients) and belief states about the effectiveness of the investigated drug and a standard treatment drug. Using Bayesian updates and dynamic programming, we establish monotonicity of the value function in state variables and characterize an optimal enrollment policy. We also introduce, for the first time, the use of backward approximate dynamic programming (ADP) for this problem class. We illustrate the findings using a clinical trial program from a leading firm. Our study performs sensitivity analyses of the input parameters on the optimal enrollment policy. Results: The value function is monotonic in cumulative patient enrollment and the average responses of treatment for the investigated drug and standard treatment drug. The optimal enrollment policy is nondecreasing in the average response from patients using the investigated drug and is nonincreasing in cumulative patient enrollment in periods between two successive interim analyses. The forward ADP algorithm (or backward ADP algorithm) exploiting the monotonicity of the value function reduced the run time from 1.5 months using the exact method to a day (or 20 minutes) within 4% of the exact method. Through an application to a leading firm’s clinical trial program, the study demonstrates that the firm can have a sizable gain of drug profit following the optimal policy that our model provides. Managerial implications: We developed a new model for improving the management of clinical trials. Our study provides insights of an optimal policy and insights into the sensitivity of value function to the dropout rate and prior probability distribution. A firm can have a sizable gain in the drug’s profit by managing its trials using the optimal policies and the properties of value function. We illustrated that firms can use the ADP algorithms to develop their patient enrollment strategies.

Elimination of Low-Osmolality Contrast Media by Hemodialysis

1996 ◽  
Vol 37 (3P2) ◽  
pp. 966-971 ◽  
Author(s):  
T. Furukawa ◽  
J. Ueda ◽  
S. Takahashi ◽  
K. Sakaguchi
Keyword(s):  
Contrast Media ◽  
Contrast Medium ◽  
Adverse Reactions ◽  
Elimination Rate ◽  
Hemodialysis Patients ◽  
Hemodynamic Changes ◽  
End Stage Renal Failure ◽  
End Stage ◽  
Sampling Times ◽  
Regular Hemodialysis

Purpose: To compare the dialyzability and safety of 2 types of low-osmolality contrast media administered to end-stage renal failure patients maintained on regular hemodialysis. Material and Methods: Of 44 CT examinations, iohexol was used in 22 and ioxaglate in the other 22. Adverse reactions and hemodynamic changes were recorded. Thirty minutes after the beginning of CT investigation, hemodialysis was commenced. Elimination rate and clearance of the contrast media were measured as indices of their dialyzability. Results: After 4 hours of hemodialysis, 78.4±6.5% of iohexol and 72.4±6.0% ioxaglate were eliminated. Clearance of iohexol was higher than that of ioxaglate at all sampling times. No severe hemodynamic change nor adverse reaction were observed. Minor reactions were more frequently observed in the ioxaglate group. Conclusion: Iohexol, a nonionic monomeric contrast medium, is more advantageous for hemodialysis patients than ioxaglate, an ionic dimeric contrast medium.

Gd-DTPA in Male Urethrography

1996 ◽  
Vol 37 (3P2) ◽  
pp. 804-805 ◽  
Author(s):  
T. Vehmas ◽  
P. Tervahartiala
Keyword(s):  
Side Effects ◽  
Contrast Media ◽  
Contrast Medium ◽  
Case History ◽  
Adverse Reactions ◽  
Urethral Diverticulum ◽  
Radiological Examination ◽  
X Ray ◽  
History Of ◽  
Good Contrast

Patients with a case history of severe side-effects from iodine-containing contrast media present problems in later radiological examination. We report here on an alternative, the first extravascular use of Gd-DTPA in an X-ray urethrography. By using the standard processing algorithm of our digital radiographic equipment and 60 ml undiluted Gd-DTPA meglumine (469 mg/ml) we achieved good contrast and could exclude the suspected urethral diverticulum in a 26-year-old man. No adverse reactions occurred. Gd-DTPA seems to offer a reasonable contrast and may be used as an alternative extravascular contrast medium in selected conventional radiographic studies.

scholarly journals LEGAL ASPECTS OF CLINICAL TRIALS IN POLAND

2017 ◽  
Vol 28 (1) ◽  
pp. 67-84
Author(s):  
Katarzyna Syroka-Marczewska
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Reactions ◽  
Legal Aspects ◽  
Science And Society ◽  
Medicinal Products ◽  
Safety And Efficacy ◽  
Pharmacodynamic Effects ◽  
Trial Participants

A clinical trial is each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy. It ought to be remembered that clinical trials may be conducted with the use of medicinal products. Clinical trials must be conducted in a way which is in line with the primary principle that clinical trial participants’ rights, safety, health, and welfare override the interest of science and society.

scholarly journals Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA

Bioanalysis ◽  
2020 ◽  
Vol 12 (19) ◽  
pp. 1363-1375
Author(s):  
Katrina M Nolan ◽  
Yuhua Zhang ◽  
Joseph M Antonello ◽  
Adrienne H Howlett ◽  
Cyrille J Bonhomme ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conjugate Vaccine ◽  
Threshold Value ◽  
Phase Iii ◽  
Capsular Polysaccharides ◽  
Acceptance Criteria ◽  
Phase Iii Clinical Trial ◽  
Assay Validation ◽  
Clinical Trial Program

Aim: To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate and bridge the enhanced assay to the WHO ELISA, to support the Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. Materials & methods: The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. Results: The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. Conclusion: The enhanced Pn ECL assay has been validated for the measurement of antibodies to 15 Pn capsular polysaccharides and is concordant with the WHO ELISA, supporting its use in clinical trials.

Immediate and LAte Adverse Reactions in Coronary Angiography

1996 ◽  
Vol 37 (1P1) ◽  
pp. 218-222 ◽  
Author(s):  
S.-G. Fransson ◽  
G. Stenport ◽  
M. Andersson
Keyword(s):  
Myocardial Infarction ◽  
Cardiovascular Disease ◽  
Coronary Angiography ◽  
Contrast Media ◽  
Contrast Medium ◽  
Left Coronary Artery ◽  
Adverse Reactions ◽  
Parallel Study ◽  
Double Blind ◽  
Blood Pressures

Purpose and Methods: In 120 patients in a double-blind, randomized, parallel study, iodixanol (Visipaque), a nonionic dimer isotonic with blood, was compared with ioxaglate (Hexabrix), an ionic low-osmolar dimer, in coronary angiography regarding early and late adverse reactions. Haemodynamic and electrophysiologic parameters were also analyzed. Results: Visipaque resulted in significantly fewer early adverse contrast medium-related reactions (p<0.05). Visipaque also demonstrated significantly fewer effects on electrophysiologic parameters. Both contrast media reduced systolic and diastolic blood pressures at the 1st injection in the left coronary artery. Late adverse reactions were unusual with both contrast media and occurred only as urticaria with a frequency of 1.7%, which is lower than reported in i.v. studies. One serious adverse reaction, a myocardial infarction in a male patient with severe cardiovascular disease, occurred in the Visipaque group. This event was considered to be procedure- and disease-related rather than related to the type of contrast medium used. Conclusion: We found Visipaque safe for coronary angiography, causing fewer early adverse reactions than Hexabrix and also fewer effects on electrophysiologic parameters. Late adverse reactions seemed to be unusual with intra-arterial administration of contrast media.

Quality of Marginal Adaptation Evaluation of Posterior Composites in Clinical Trials

2003 ◽  
Vol 82 (1) ◽  
pp. 59-63 ◽  
Author(s):  
M. Hayashi ◽  
N.H.F. Wilson ◽  
D.C. Watts
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Subjective Assessment ◽  
Step Height ◽  
Marginal Adaptation ◽  
Clinical Criteria ◽  
Usphs Criteria ◽  
The Mean ◽  
Clinical Trial Program

The evaluation of margins of restorations in clinical trials relies on the subjective assessment of evaluators, with no instrument having been developed, let alone validated, to assist in the process. The purpose of the present study was to assess the quality of evaluations of marginal adaptation by analyzing the distribution of marginal steps rated according to clinical criteria. Replicas of 435 restorations, the marginal qualities of which had been evaluated according to modified USPHS criteria, were randomly selected from the Occlusin TM multi-center clinical trial program. The marginal step height in the most deteriorated area of each restoration was measured by means of a digital step-height instrument. An overlap between the steps in the restorations with A (Alfa; replacement unnecessary) and B (Bravo; replacement questionable) ratings was found to be in the range of 101 μm to 321 μm. When the steps with a height greater or less than one standard deviation of the mean were excluded, the overlap was reduced to a range of 168 μm to 173 μm. This finding indicates a marginal height boundary between A and B ratings for marginal adaptation of 170 ± 3 μm.

Clinical Trial Program for Iopentol A New Nonionic Ratio 3.0 Contrast Medium with Emphasis on Clinical Phases I and II

1988 ◽  
Vol 23 ◽  
pp. S189-S192 ◽  
Author(s):  
E. ANDREW ◽  
A. WAALER ◽  
J. JAKOBSEN ◽  
T. HOLAGER ◽  
M. LAMBRECHTS ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Contrast Medium ◽  
Clinical Trial Program

scholarly journals COVID-19, SARS, MERS and Ebola: a comparative analysis registration of intervention clinical trials

2020 ◽  
Author(s):  
Yuxia Xiang ◽  
Zeyu Zhang ◽  
Chan Zeng ◽  
Zhanqing Hu ◽  
Yaxin Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Trial Registry ◽  
Drug Intervention ◽  
Short Period ◽  
Epidemic Period ◽  
Virulent Virus ◽  
Intervention Trials ◽  
Clinical Trial Program

Abstract BackgroundCOVID-19 is a novel and highly virulent virus, which caused a rapid and massive onset of clinical trials in a short period of time.With the aim to obtain suggestions in the guidance on performing emergency clinical trials, and control this virus in China and other countries and for the prevention of the onset of other infectious viruses in the future.MethodsCOVID-19, SARS, MERS and Ebola clinical trials registered in the Chinese clinical trial registry and clinical trials.gov were collected and analyzed and intervention protocols were compared, focusing on the analysis and comparison of the drug used. The search period ended on February 24, 2020.ResultsThe number of the registered COVID-19 clinical trials was 295. Among 203 intervention trials, 78.3% (159) were drug clinical trials, in which 46.3% (94) used chemical drugs and biological agents, 32.0% (65) were performed using Traditional Chinese Medicine (TCM) and integrated traditional Chinese and western medicine.The 159 COVID-19 trials were designed and analyzed with the highest proportion of blank randomized controls [45.9% (73)], and placebo randomized trials [14.5% (23)]. The drug mostly used was Lopinavir/Ritonavir (15.1%). The sample size ranged from 10 to 100 in 52.8% (84) trials. The number of the registered SARS was 6, MERS 15, and Ebola 97. Among 3 MERS and 19 Ebola drug intervention clinical trials, MERS and Ebola were randomized, blind, and placebo-controlled drug clinical trials accounting for 100% (3) and 31.6% (6), respectively, while SARS were vaccine trials, without drug intervention clinical trials registered.ConclusionsCompared with the SARS in 2003, the awareness and capability of clinical research in China greatly improved. However, some of the COVID-19 clinical trials and drug selection performed are somewhat disordered, requiring greater attention to the needs, science assumptions, ethics and quality management of the clinical research. Thus, during the epidemic period, the country should deliver guidance on how to perform appropriate emergency clinical trials, design a scientifically based clinical trial program and focus on researching drugs or vaccines that have great potential.

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