scholarly journals Evaluating the Efficacy of Therapies in Patients With Coronavirus Disease 2019

2020 ◽  
Author(s):  
Dan-Yu Lin ◽  
Donglin Zeng ◽  
Joseph J Eron
Keyword(s):  
Clinical Trials ◽  
Clinical Course ◽  
Clinical Status ◽  
Therapeutic Agents ◽  
Simulation Studies ◽  
Specific Change ◽  
Extensive Simulation ◽  
Clinical Events ◽  
Full Picture

Abstract There is a proliferation of clinical trials worldwide to find effective therapies for patients diagnosed with coronavirus disease 2019 (COVID-19). The endpoints that are currently used to evaluate the efficacy of therapeutic agents against COVID-19 are focused on clinical status at a particular day or on time to a specific change of clinical status. To provide a full picture of the clinical course of a patient and make complete use of available data, we consider the trajectory of clinical status over the entire follow-up period. We also show how to combine the evidence of treatment effects on the occurrences of various clinical events. We compare the proposed and existing endpoints through extensive simulation studies. Finally, we provide guidelines on establishing the benefits of treatments.

Impact of unequal censoring and insufficient follow-up on comparing survival outcomes: Applications to clinical studies

2021 ◽  
pp. 096228022110175
Author(s):  
Deo Kumar Srivastava ◽  
E Olusegun George ◽  
Zhaohua Lu ◽  
Shesh N Rai
Keyword(s):  
Clinical Trials ◽  
Cardiovascular Events ◽  
Survival Outcomes ◽  
Simulation Studies ◽  
Extensive Simulation ◽  
Statistical Procedures ◽  
Survival Endpoints ◽  
Lost To Follow Up ◽  
The Impact

Clinical trials with survival endpoints are typically designed to enroll patients for a specified number of years, (usually 2–3 years) with another specified duration of follow-up (usually 2–3 years). Under this scheme, patients who are alive or free of the event of interest at the termination of the study are censored. Consequently, a patient may be censored due to insufficient follow-up duration or due to being lost to follow-up. Potentially, this process could lead to unequal censoring in the treatment arms and lead to inaccurate and adverse conclusions about treatment effects. In this article, using extensive simulation studies, we assess the impact of such censorings on statistical procedures (the generalized logrank tests) for comparing two survival distributions and illustrate our observations by revisiting Mukherjee et al.’s 1 findings of cardiovascular events in patients who took Rofecoxib (Vioxx).

scholarly journals Incidence and Predictors of Infections and All-Cause Death in Patients with Cardiac Implantable Electronic Devices: The Italian Nationwide RI-AIAC Registry

2022 ◽  
Vol 12 (1) ◽  
pp. 91
Author(s):  
Giuseppe Boriani ◽  
Marco Proietti ◽  
Matteo Bertini ◽  
Igor Diemberger ◽  
Pietro Palmisano ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Clinical Status ◽  
Electronic Devices ◽  
Clinical Event ◽  
Clinical Factors ◽  
Factors Associated ◽  
Cardiac Implantable Electronic Devices ◽  
Clinical Events ◽  
Event Score

Background: The incidence of infections associated with cardiac implantable electronic devices (CIEDs) and patient outcomes are not fully known. Aim: To provide a contemporary assessment of the risk of CIEDs infection and associated clinical outcomes. Methods: In Italy, 18 centres enrolled all consecutive patients undergoing a CIED procedure and entered a 12-months follow-up. CIED infections, as well as a composite clinical event of infection or all-cause death were recorded. Results: A total of 2675 patients (64.3% male, age 78 (70–84)) were enrolled. During follow up 28 (1.1%) CIED infections and 132 (5%) deaths, with 152 (5.7%) composite clinical events were observed. At a multivariate analysis, the type of procedure (revision/upgrading/reimplantation) (OR: 4.08, 95% CI: 1.38–12.08) and diabetes (OR: 2.22, 95% CI: 1.02–4.84) were found as main clinical factors associated to CIED infection. Both the PADIT score and the RI-AIAC Infection score were significantly associated with CIED infections, with the RI-AIAC infection score showing the strongest association (OR: 2.38, 95% CI: 1.60–3.55 for each point), with a c-index = 0.64 (0.52–0.75), p = 0.015. Regarding the occurrence of composite clinical events, the Kolek score, the Shariff score and the RI-AIAC Event score all predicted the outcome, with an AUC for the RI-AIAC Event score equal to 0.67 (0.63−0.71) p < 0.001. Conclusions: In this Italian nationwide cohort of patients, while the incidence of CIED infections was substantially low, the rate of the composite clinical outcome of infection or all-cause death was quite high and associated with several clinical factors depicting a more impaired clinical status.

Extracapillary Proliferative Glomerulonephritis in Children

PEDIATRICS ◽  
1975 ◽  
Vol 56 (3) ◽  
pp. 434-442
Author(s):  
Sudhir K. Anand ◽  
Carl W. Trygstad ◽  
Hari M. Sharma ◽  
James D. Northway
Keyword(s):  
Streptococcal Infection ◽  
Clinical Course ◽  
Renal Involvement ◽  
Therapeutic Agents ◽  
Proliferative Glomerulonephritis ◽  
The Mean ◽  
Histopathologic Changes ◽  
Better Than

The clinical course and renal pathology of 17 children with acute extracapillary proliferative glomerulonephritis is reported. Patients with systemic ses associated with renal involvement were excluded. The onset followed streptococcal infection in ten; of these, four have died, one has been transplanted, and the remaining five have completely healed. The mean follow-up of the latter five patients was 32 months (range, 18 to 57 months). Of the other seven patients without evidence of preceding streptococcal infection, two have died, two have been transplanted, and the remaining three all have hypertension, proteinuria, and reduced creatinine clearance. The mean follow-up of the latter three patients was 29 months (range, 14 to 38 months). The initial renal histopathologic changes and their progress in later renal biopsies is described. The role of various therapeutic agents is discussed. The prognosis in acute extracapillary proliferative glomerulonephritis following streptococcal infection appears to be better than in ones without preceding streptococcal infection.

Prognostic features in childhood idiopathic dilated cardiomyopathy

1997 ◽  
Vol 7 (2) ◽  
pp. 183-187
Author(s):  
Karen S. Rheuban ◽  
Donna Cregan-Lambert ◽  
Howard P. Gutgesell
Keyword(s):  
Clinical Outcome ◽  
Heart Transplantation ◽  
Dilated Cardiomyopathy ◽  
Clinical Course ◽  
Clinical Status ◽  
Idiopathic Dilated Cardiomyopathy ◽  
Poor Clinical Outcome ◽  
Short Term ◽  
Prognostic Features

AbstractThe clinical course, noninvasive findings and outcome of 25 infants and children with idiopathic dilated cardiomyopathy were reviewed retrospectively to identify factors predictive of outcome both at diagnosis and at short-term follow-up. Patients, stratified by clinical status at last visit, were assigned to groups encompassing those who were asymptomatic and receiving on medication, those patients who were symptomatic or needed medication to control symptoms, and those who were dead, awaiting heart transplantation, or had undergone transplantation. Older age at diagnosis was strongly associated with poor clinical outcome (p=0.005), as was the presence of arrhythmias at the time of diagnosis (p=0.008) and at short-term follow-up-(p=0.003). Echocardiographic studies at diagnosis failed to predict eventual clinical outcome, although patients who ultimately recovered and did not need medications tended to demonstrate improvement in or resolution of echocardiographic abnormalities within 6 months of diagnosis.

scholarly journals The clinical course of a 79-year-old stroke survivor in the setting of a late-onset COVID-19 infection

2022 ◽  
Vol 10 ◽  
pp. 2050313X2110666
Author(s):  
Salih Ahmeti ◽  
Violeta Lokaj-Berisha ◽  
Besa Gacaferri Lumezi
Keyword(s):  
Clinical Course ◽  
Late Onset ◽  
Clinical Status ◽  
Recovery Period ◽  
Antiviral Drug ◽  
Stroke Survivor ◽  
Therapeutic Agents ◽  
Clinical Activity ◽  
Hospitalization Period ◽  
Old Left

Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (COVID-19), no specific antiviral drug has been proven effective for the treatment of patients with severe complications. However, a nucleoside prodrug remdesivir (GS-5734) was recently approved by the Food and Drug Administration for the treatment of hospitalized patients with COVID-19. Preclinical data in animal models of coronavirus diseases have demonstrated that early treatment with remdesivir leads to improved survival and decreased lung injury. Recent clinical data have demonstrated the clinical activity of remdesivir in terms of shorter recovery period and higher odds of improved clinical status in patients with COVID-19. Here, the story of a 79-year-old patient, with 11-year-old left hemiparesis, concomitant cardiovascular disease, infected with SARS-CoV-2, and the clinical improvement after administration of remdesivir during his second hospitalization period is reported.

THYROID TYPE CARCINOMA ARISING IN STRUMA OVARII. SIX CLINICAL CASES AND REVIEW

2018 ◽  
Vol 64 (6) ◽  
pp. 708-715
Author(s):  
Natalya Severskaya ◽  
Andrey Rodichev ◽  
Aleksey Ilin ◽  
Dmitriy Semin ◽  
Pavel Isaev ◽  
...  
Keyword(s):  
Radioiodine Therapy ◽  
Clinical Course ◽  
Case Reports ◽  
Thyroid Tissue ◽  
Follicular Carcinoma ◽  
Complete Response ◽  
Pelvic Surgery ◽  
Ovarian Teratoma ◽  
Struma Ovarii

Struma ovarii is a rare variant of the mature ovarian teratoma composed of more than 50% thyroid tissue. Thyroid type carcinoma can occur in 5% of struma ovarii. Given the rarity of this pathology, as well as the different clinical course, approaches to the treatment of this disease are controversial. The proposed approaches to treatment vary from ovarian resection to total hysterectomy with bilateral salpingo-oophorectomy and adjuvant therapy. We present here 6 case reports of thyroid type carcinoma in struma ovarii and outcome of patients treated in our clinic. All patients had pelvic surgery of different extent, followed by thyroidectomy and radioiodine therapy. The incidence of metastasis is 67% (4/6), 2 - intraperitoneal metas-tases, 2 - bone metastases. Among patients with metastases, 2 have reached a complete response, one with a good response continues treatment, one had progression. The follow-up period is 1 to 15 years (median 4 years). One patient with follicular carcinoma died of progression 8 years after diagnosis. The remaining patients are alive.

Targeting p53-MDM2 Interaction Using Small Molecule Inhibitors and the Challenges Needed to be Addressed

2019 ◽  
Vol 20 (11) ◽  
pp. 1091-1111 ◽  
Author(s):  
Maryam Zanjirband ◽  
Soheila Rahgozar
Keyword(s):  
Clinical Trials ◽  
Small Molecule ◽  
Small Molecule Inhibitors ◽  
Tp53 Gene ◽  
Therapeutic Agents ◽  
Negative Regulator ◽  
Mdm2 Protein ◽  
Independent Effects ◽  
Small Hydrophobic ◽  
Targeted Therapeutic

MDM2 protein is the core negative regulator of p53 that maintains the cellular levels of p53 at a low level in normal cells. Mutation of the TP53 gene accounts for 50% of all human cancers. In the remaining malignancies with wild-type TP53, p53 function is inhibited through other mechanisms. Recently, synthetic small molecule inhibitors have been developed which target a small hydrophobic pocket on MDM2 to which p53 normally binds. Given that MDM2-p53 antagonists have been undergoing clinical trials for different types of cancer, this review illustrates different aspects of these new cancer targeted therapeutic agents with the focus on the major advances in the field. It emphasizes on the p53 function, regulation of p53, targeting of the p53-MDM2 interaction for cancer therapy, and p53-dependent and -independent effects of inhibition of p53-MDM2 interaction. Then, representatives of small molecule MDM2-p53 binding antagonists are introduced with a focus on those entered into clinical trials. Furthermore, the review discusses the gene signatures in order to predict sensitivity to MDM2 antagonists, potential side effects and the reasons for the observed hematotoxicity, mechanisms of resistance to these drugs, their evaluation as monotherapy or in combination with conventional chemotherapy or with other targeted therapeutic agents. Finally, it highlights the certainly intriguing questions and challenges which would be addressed in future studies.

scholarly journals When less is more: a daring conservative approach to postpneumonectomy oesophago-pleural fistula

2019 ◽  
Vol 30 (1) ◽  
pp. 146-148
Author(s):  
Lara Girelli ◽  
Elena Prisciandaro ◽  
Niccolò Filippi ◽  
Lorenzo Spaggiari
Keyword(s):  
Clinical Presentation ◽  
Clinical Status ◽  
High Morbidity ◽  
Conservative Approach ◽  
Chronic Fistula ◽  
Less Is More ◽  
Primary Surgery ◽  
History Of ◽  
Uncommon Complication

Abstract Oesophago-pleural fistula is an uncommon complication after pneumonectomy, usually related to high morbidity and mortality. Due to its rarity and heterogeneous clinical presentation, its diagnosis and management are challenging issues. Here, we report the case of a patient with a history of pneumonectomy for a tracheal tumour, who developed an asymptomatic oesophago-pleural fistula 7 years after primary surgery. In consideration of the patient’s good clinical status and after verifying the preservation of respiratory and digestive functions, a bold conservative approach was adopted. Five-year follow-up computed tomography did not disclose any sign of recurrence of disease and showed a stable, chronic fistula.

scholarly journals Severe tricuspid regurgitation 14 years after diagnosis of “transient neonatal tricuspid regurgitation”

Heart ◽  
2001 ◽  
Vol 86 (1) ◽  
pp. 88-90
Author(s):  
D Boshoff ◽  
L Mertens ◽  
M Gewillig
Keyword(s):  
Tricuspid Regurgitation ◽  
Neonatal Period ◽  
Clinical Course ◽  
Subsequent Evolution ◽  
Severe Tricuspid Regurgitation ◽  
Echocardiographic Examination ◽  
Long Term Follow Up ◽  
Transient Tricuspid Regurgitation

A 14 year old girl presented with severe tricuspid regurgitation after she was diagnosed with “transient tricuspid regurgitation of the newborn”. In the neonatal period she had presented with severe tricuspid regurgitation without an obvious underlying anatomical cause. This spontaneously regressed during the first months of life. She was dismissed from follow up at the age of 5 years after complete normalisation of the clinical and echocardiographic examination. The subsequent evolution and management of the patient, as well as the possible pathogenesis responsible for the unusual clinical course, is discussed. This case stresses the importance of long term follow up of patients with transient tricuspid regurgitation.

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