Can passive pedaling improve sexual function in patients under hemodialysis? A randomized clinical trial

To investigate the effect of passive pedaling with mini bike on sexual function in patients under hemodialysis. This study was a randomized clinical trial. Thirty-seven patients undergoing hemodialysis were assigned to the intervention (n = 20) and control (n = 17) groups by the stratified block randomization method. The intervention group exercised with a mini bike that was automatic and tuned for patients during the first 2 h of dialysis, twice a week for 20 min each time, for 3 months. The International Index of Erectile Function and Female Sexual Function Index were used to assess the sexual function in the first, second, and third months during the intervention and one month after the intervention. A higher score indicates a better sexual function. Repeated measure ANOVA, Chi–square and Fisher exact tests, independent t, and Mann–Whitney U tests were used for data analysis. The SPSS software version 22 was used for data analysis. Sexual function scores of the intervention group were 35.9 at the beginning of the study, 34.1 in the first month, 37.4 in the second month, 34.8 in the third month, and 31.7 one month after the study. There was no significant difference in the scores of sexual function in the intervention group during the study. The mean scores of sexual function in the control group were 34.5, 34.4, 34.9, 33.8, and 33.9 at the beginning of the study, in the first month, in the second month, in the third month, and one month after the study, respectively (p > 0.05). There was no significant difference between the two groups in terms of sexual function scores during and after the intervention (p > 0.05). Passive pedaling with mini-bike had no effect on sexual function of hemodialysis patients.     

Intra-abdominal desmoid tumors mimicking gastrointestinal stromal tumors——8 cases: A case report

BACKGROUND Intra-abdominal desmoid tumors(DTs) can mimic recurrence or progression of gastrointestinal stromal tumors(GISTs). Differential diagnosis is important to avoid unnecessary or inappropriate treatment.CASE SUMMARY All 8 patients experienced surgical resection of GIST, and median time to diagnosis of DT was 1.8 years after surgical resection. All sites of DT were in the peritoneum around the surgical sites of GIST. The following clinical suspicion coupled with radiological findings contributed to the suspicion of intraabdominal DTs:(1) Occurrence of a new single lesion in the peritoneum around the surgical sites of GIST;(2) uncontrolled lesion with imatinib while other lesions being controlled with imatinib;(3) well-defined ovoid shaped lesion with delayed or mild enhancement and absence of necrosis, hemorrhage, and cystic change on computed tomography; and(4) a lesion showing mild or no hypermetabolic activity on 18 fluorodeoxyglucose-positron emission tomography,contrary to initially hyperactive lesion of GIST. All DTs were surgically removed except for one unresectable DT and only one DT recurred at another site of peritoneum, which was also surgically removed.CONCLUSION Intra-abdominal DT should be a differential diagnosis for a new single lesion in patients with GIST.     

Deferasirox in MDS patients with transfusion-caused iron overload—a phase-II study

Blood transfusions represent a main component of supportive care in myelodysplastic syndromes (MDS). To avoid organ damage caused by transfusion-dependent iron overload, an adequate iron chelation therapy is required. Recently, a new oral iron chelator deferasirox (ICL670, Exjade) has become available. A study was conducted to demonstrate the efficacy and tolerability of deferasirox in transfusion-dependent iron-overloaded patients with MDS. The efficacy of deferasirox was monitored by changes in serum ferritin, bone marrow iron, and liver iron concentration (LIC), as determined by T2*-weighted magnetic resonance imaging. Twelve patients with MDS of different subtypes (median age 76 years, range 53-91) were enrolled. Deferasirox administered in a once-daily dose of 20-30 mg/kg for 12 months was effective in reducing median ferritin concentration from 1,515 microg/L (range 665-6,900) to 413 microg/L (range 105-3,052). Within the first 4 weeks of treatment before the continuous decline of ferritin levels, the values markedly rose in eight of 12 patients. The median LIC declined from 315 to 230 micromol/g (p=0.02) at the end of study, accompanied by a reduction of bone marrow siderosis. The most common adverse events were mild and transient gastrointestinal disturbances, skin rash, nonprogressive transient increases in serum creatinine and urine beta2-microglobulin, and a temporary reduction of the creatinine clearance. The renal parameters normalized after end of treatment. No hematologic toxicities were observed. Deferasirox proved to be effective in transfusion-dependent iron overload in MDS by mobilizing iron deposits in liver and at least stabilizing iron stores in bone marrow.     

Trachoma: Can trichiasis be treated with a sticking-plaster? A randomized clinical trial in China

Trachoma is the most frequent cause of preventable blindness in the world. At the trichiasis/entropion stage, lid surgery is recommended, but many patients only use epilation, which does not prevent loss of vision. We developed a new treatment that should be more accessible than lid surgery and more effective than epilation: a sticking plaster that forces eyelashes back to their correct position. The first randomized controlled trial was conducted in Shanghai with 57 patients to compare the plaster method with epilation. After 3 months of follow-up, with no attrition, 67% of those treated by the new method presented a good clinical status, vs none of those treated by epilation (P < 0.001). The new treatment was well tolerated and lid function remained normal. Although our results show overwhelming benefit of this new, simple treatment for trachoma at the trichiasis stage, more research is needed at the primary health care level and in other settings to determine the potential use of the new method on a large scale and by nonspecialists.     

The use of a transparent cap in sigmoidoscopy—A randomized controlled clinical trial on pain,time and success rate

Trials on cap-assisted colonoscopy have shown a reduction in pain, faster intubation time and a higher success rate attributed to the use of the cap. No similar studies have been published on sigmoidoscopy even though it is a common procedure associated with significant pain. Our objective was to investigate whether the use of a transparent cap for sigmoidoscopy has an impact on pain, time or success rate. To mimic the tendencies of daily clinical practice, the trainee endoscopist performed the procedures, and no analgesics or sedatives were used. We conducted a randomized, controlled clinical trial with a parallel design consisting of two groups masked for the intervention. The primary endpoint was pain, recorded on a 100-mm visual analogue scale (VAS). Our results found cap-assisted sigmoidoscopy to be significantly more painful than non-cap-assisted sigmoidoscopy (median VAS 50 vs. 38 mm; p = 0.047). We found no differences on time or success rate due to the cap. Our results suggest pain management, e.g. analgesics which is not routinely used for sigmoidoscopy, when a cap is used to gain therapeutic or diagnostic advantages. ClinicalTrials.gov Identifier: NCT02243930     

Treatment intensification in a hypertension telemanagement trial: clinical inertia or good clinical judgment?

Clinical inertia represents a barrier to hypertension management. As part of a hypertension telemanagement trial designed to overcome clinical inertia, we evaluated study physician reactions to elevated home blood pressures. We studied 296 patients from the Hypertension Intervention Nurse Telemedicine Study who received telemonitoring and study physician medication management. When a patient's 2-week mean home blood pressure was elevated, an "intervention alert" prompted study physicians to consider treatment intensification. We examined treatment intensification rates and subsequent blood pressure control. Patients generated 1216 intervention alerts during the 18-month intervention. Of 922 eligible intervention alerts, study physicians intensified treatment in 374 (40.6%). Study physician perception that home blood pressure was acceptable was the most common rationale for nonintensification (53.7%). When "blood pressure acceptable" was the reason for not intensifying treatment, the mean blood pressure was lower than for intervention alerts where treatment intensification occurred (135.3/76.7 versus 143.2/80.6 mm Hg; P<0.0001). Blood pressure acceptable intervention alerts were associated with the lowest incidence of repeat alerts (hazard ratio: 0.69 [95% CI: 0.58 to 0.83]), meaning that the patient home blood pressure was less likely to subsequently rise above goal, despite apparent clinical inertia. This telemedicine intervention targeting clinical inertia did not guarantee treatment intensification in response to elevated home blood pressures. However, when physicians did not intensify treatment, it was because blood pressure was closer to an acceptable threshold, and repeat blood pressure elevations occurred less frequently. Failure to intensify treatment when home blood pressure is elevated may, at times, represent good clinical judgment, not clinical inertia.     

Experimental and clinical study on tumor infiltrating lymphocytes in solid tumor

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Spontaneous tumor lysis syndrome in solid tumors: really a rare condition?

Acute tumor lysis syndrome (ATLS), which occurs spontaneously, without cytotoxic therapy, is a rare condition. Spontaneous TLS (STLS) has been seen most commonly in lymphoma and leukemia. We report a series of 3 cases of STLS in patients with solid tumors who were hospitalized in our department during a 9-month period and suggest that STLS is probably more frequent than previously thought.     

Are clinical trials in rheumatoid arthritis generalizable to routine practice? A re-evaluation of trial entry criteria

OBJECTIVE: Trials of disease-modifying anti-rheumatic drugs (DMARDs) enrol active rheumatoid arthritis patients identified using standard criteria (three out of four of: >/=6 tender joints, >/=6 swollen joints, ESR >/= 28 mm/h, >/=45 min morning stiffness). Concern has been expressed about generalizability, as many patients in routine practice have less active disease. Furthermore, these criteria do not map onto standard disease activity and treatment response measures. We examined how many routine patients were sufficiently active to meet trial recruitment criteria and whether alternative definitions of active disease were more appropriate. METHODS: We studied 504 patients in a cross-sectional study, 156 in a longitudinal study and 94 starting new DMARDs or biologics. Patients were classified as 'trial active' (met entry criteria), in remission or 'intermediately active' (between the two). We also evaluated the effect of amendments to criteria. RESULTS: Cross-sectionally only 38% patients were 'trial active', but longitudinally 68% were 'trial active' at least once. Thus, many clinic patients do have disease activity below the level required for trial entry, but over time most reach eligibility levels. More (62%) of the cohort starting new treatment were 'trial active', suggesting that recruitment criteria relate to clinical decisions. Criteria omitting morning stiffness and a disease activity score (DAS28) >/=5.4 replicated the classification given by current criteria. CONCLUSIONS: Trial results can be generalized to routine practice because most clinic patients are 'trial active' when their therapy is changed and most become 'trial active' over time. As DAS-based criteria are simpler and relate directly to response measures, their use should be considered in future.     

A clinical trial of rosiglitazone and 5-aminosalicylate combination for ulcerative colitis

Objective To investigate the therapeutic effects of the combination of rosiglitazone, which is peroxisome proliferators-activated receptorγ(PPARγ) ligands used to treat type 2 diabetes mellitus, and aminosalicylate on mildly or moderately active ulcerative colitis and on relevant cytokine expressions. Methods According to the     

Do commonly used clinical trial designs reflect clinical reality?

This paper contends that commonly used clinical trial designs do not reflect clinical reality as viewed by patients or physicians. Specifically, randomized phase III designs focus on improvements that are more significant statistically than medically and put an emphasis on avoiding a false positive result that is more appropriate for diseases that are curable, in contrast to acute leukemias. The resultant large sample sizes needed for each treatment restrict the trial to one or two new treatments, although historical reality suggests the difficulty in knowing, without clinical data, whether these are the best of several new treatments. The p value-based statistics discourage use of data from previous patients in the trial to inform treatment of subsequent patients, contravening patients’ assumptions. Standard phase II trials focus on a single outcome, ignoring the complexity of medical practice, and ignore prognostic heterogeneity. Finally, although patients are more interested in whether a new treatment is better than another, rather than whether it is active, randomization between different treatments does not begin until phase II trials have been completed. This paper proposes alternatives based on the Bayesian statistical approach. The thesis that I will develop here is that commonly used clinical trial designs are unrealistic in the sense that they do not correspond well to patients’ views of medical practice and greatly over-simplify such practice. By emphasizing Bayesian rather than p value-based statistics and focusing on acute myeloid leukemia, I hope to familiarize physicians with some of the many new published designs that address these problems.     

Need to reinvigorateTuberculosis research in India – A review of studies registered under clinical trial registry of India

Tuberculosis (TB) is one of the most serious public health issues in India. According to the global TB report 2020, India accounts for about one-quarter of the global TB burden. Despite considerable advances in mandatory notification of all TB cases, incorporation of the national health programmes with general health services (National Health Mission), and national drug resistance surveillance and many other accomplishments, much more needs to be considered in India to significantly decrease TB incidence. Research is the foundation for medical breakthroughs. In this study, all Tuberculosis-related studies registered under Clinical Trial Registry of India from its inception in July 2007 to February 2021 were reviewed and analysed using the keyword ‘’Tuberculosis’’ in the ‘Trial Search’ section. A total of 31,196 studies were registered in CTRI, with 180 studies (0.58%) being related to tuberculosis. Of these studies, 76 (42.2%) were interventional in nature. These consisted of evaluating different management or treatment TB (50%, n = 90), diagnostic studies (19.4%, n = 35) and studies related to screening and prevention of TB (7.8%, n = 14). Maximum studies were conducted to evaluate safety and efficacy of anti-TB drugs (10%, n = 18) and to evaluate efficacy of shortening of duration of treatment (8.9%, n = 16). The studies related to extra pulmonary TB, MDR TB and TB in special populations and sources of funding and locations of the study sites were also analysed. These indicate that only minimal TB-related researches are conducted in India. It is indispensable to promote tuberculosis research in India in order to eradicate this infectious disease.     

ISCHEMIA trial: Is there enough evidence to drive a change in clinical practice? A critical appraisal

Recently, ISCHEMIA trial was published in order to determine the effect of adding cardiac catheterization and revascularization when feasible to medical therapy in patients with stable CAD and moderate or severe ischemia. Over a median of 3.2 years of follow-up, among patients with stable CAD who had moderate or severe ischemia on stress testing, an initial invasive strategy, as compared with an initial conservative strategy, did not reduce the rates of the primary or key secondary composite outcomes. The primary outcome was the composite of death from cardiovascular causes, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. The key secondary outcomes were the composite of death from cardiovascular causes or MI and angina-related quality of life. Patients in the invasive-strategy group had more procedural myocardial MIs, and they had fewer spontaneous infarctions during follow-up. The incidence of death from any cause was low and similar in the two groups. However, the ISCHEMIA trial was challenging to implement, event rates were low and enrollment fell behind initial milestones. Furthermore, power of the study was compromised, composite end-point definition as well as definitions of crucial individual components were changed amid study progression. There was a “heterobaric” combined end-point with procedural MIs favoring the conservative arm and spontaneous MIs favoring the invasive arm. Finally, the duration of reported follow-up showed signals that findings may shift in favor of invasive treatment and results were sensitive to definition and type of MIs. Therefore, we believe that it is premature to change clinical practice in view of the results of ISCHEMIA trial. As stable CAD patients is a vastly heterogenous patient group, it may be prudent to apply common clinical judgement and individual decision-making according to current guidelines before changing our management strategies.     

Facilitating increased participation in clinical trials: what do consumers expect of clinical trial matching websites?

Clinical trials offer access to novel therapies and potential major benefits for patients, but identifying and accessing suitable trials remains a significant challenge for consumers. A burgeoning range of online services aims to meet this need; however, there is a paucity of data on whether these services are addressing the requirements and concerns of consumers. Here, we report our findings from a survey of cancer consumers, with results we believe are relevant to the broader research community.