scholarly journals Enteroadsorbent Polymethylsiloxane Polyhydrate vs. Probiotic Lactobacillus reuteri DSM 17938 in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers, a Randomized Controlled Trial

2020 ◽  
Vol 8 ◽  
Author(s):  
Leo Markovinović ◽  
Ivica Knezović ◽  
Tihana Kniewald ◽  
Lorna Stemberger Marić ◽  
Vladimir Trkulja ◽  
...  
Keyword(s):  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Similar Efficacy ◽  
University Hospital ◽  
Bowel Habit ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Recommended Treatment ◽  
Significant Difference ◽  
The University

Purpose: The aim of this study was to compare two adjunct therapies in the treatment of childhood rotavirus gastroenteritis (RVGE). We compared the recommended treatment, probiotic Lactobacillus reuteri DSM 17938 (BioGaia®), vs. a novel treatment, enterosorbent polymethylsiloxane polyhydrate (Enterosgel®).Methods: This was an open-label, randomized, clinical controlled trial at the University Hospital for Infectious Diseases (UHID) in Zagreb, Croatia. A total of 149 children aged 6–36 months with acute rotaviral gastroenteritis over a period of <48 h, with no significant chronic comorbidity, were randomized to receive the standard therapy with L. reuteri DSM 17938 (hereafter L. reuteri) or polymethylsiloxane polyhydrate (hereafter PMSPH) therapy, during 5 days. The primary end point was time to recovery in days in both groups. The recovery was defined as absence of fever and vomiting and either the first firm stool, absence of stool for more than 24 h, or return of usual bowel habit.Results: A total of 75 children were randomized into the L. reuteri group and 74 were randomized into the PMSPH group; after excluding missing data, the data from 65 children in each group were analyzed. There was no significant difference in the treatment efficacy between the two regimens with an estimated median time of recovery of 6 days in both groups (p = 0.754). No significant side effects were observed in either group.Conclusion: Novel enterosorbent PMSPH had a similar efficacy to probiotic L. reuteri in the treatment of rotaviral gastroenteritis in preschool children.Clinical Trial Registration:ClinicalTrials.gov Identifier: NCT04116307 [October 3, 2019] (retrospectively registered). https://clinicaltrials.gov/show/NCT04116307.

scholarly journals Nebulised colistin for ventilator-associated pneumonia prevention

2015 ◽  
Vol 46 (6) ◽  
pp. 1732-1739 ◽  
Author(s):  
Marios Karvouniaris ◽  
Demosthenes Makris ◽  
Paris Zygoulis ◽  
Apostolos Triantaris ◽  
Stelios Xitsas ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Multidrug Resistant ◽  
University Hospital ◽  
Incidence Density ◽  
Ventilator Associated Pneumonia ◽  
Open Label ◽  
The University ◽  
Incidence Density Rate ◽  
Density Rate

We evaluated whether prophylactic nebulised colistin could reduce ventilator-associated pneumonia (VAP) rates in an intensive care unit (ICU) setting with prevalent multidrug-resistant (MDR) bacteria.We used a single-centre, two-arm, randomised, open-label, controlled trial in a 12-bed ICU in the University Hospital of Larissa, Greece. Patient inclusion criteria included mechanical ventilation of >48 h. The two arms consisted of prophylaxis with 500 000 U colistin (Col group) or normal saline (NS group), thrice daily, for the first 10 ICU days or until extubation. The primary outcome of the study was the 30-day VAP incidence.In total, 168 patients entered the study. VAP incidence was not different between Col and NS group patients (14 (16.7%)versus25 (29.8%), respectively, p=0.07). Regarding the secondary outcomes, the intervention resulted in a lower VAP incidence density rate (11.4versus25.6, respectively, p<0.01), and less Gram-negative bacteria-VAP (p=0.03) and MDR-VAP (p=0.04). Among VAP patients (n=39), prophylaxis with inhaled colistin improved ICU survival (p=0.016). There was no evidence of increased resistance to colistin or multidrug resistance.Our findings suggest that nebulised colistin had no significant effect on VAP incidence.

Long- versus short-term androgen deprivation therapy with high-dose radiotherapy for biochemical failure after radical prostatectomy: a randomized controlled trial

2020 ◽  
Vol 16 (27) ◽  
pp. 2035-2044
Author(s):  
Charlien Berghen ◽  
Steven Joniau ◽  
Annouschka Laenen ◽  
Gaetan Devos ◽  
Kato Rans ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Androgen Deprivation Therapy ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Lymph Node Involvement ◽  
Androgen Deprivation ◽  
High Dose ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Substantial Risk

Radical prostatectomy is a well-established treatment option in the management of localized and locally advanced prostate cancer. An extended lymphadenectomy is performed in case of substantial risk for lymph node involvement. When biochemical recurrence (BCR) occurs, salvage radiotherapy (SRT) is performed. The benefit in terms of BCR-free survival (FS) and metastasis-FS by adding 6 months of androgen deprivation therapy (ADT) compared with SRT only has already been established. Retrospective evidence suggests that a longer schedule of ADT may be more beneficial compared with 6 months. This multicenter open-label randomized trial will include patients who need SRT after experiencing BCR post-radical prostatectomy with lymphadenectomy and pN0-status. Patients will be randomized for ADT duration (6 vs 24 months). Primary end point is distant metastasis-FS. Clinical Trial Registration: NCT04242017 ( ClinicalTrials.gov )

scholarly journals Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S383-S384
Author(s):  
Peyman Goldeh ◽  
Peter Kim ◽  
Salaheddin Abouanaser ◽  
Eric Partlow ◽  
Patricia Beckett ◽  
...  
Keyword(s):  
Fecal Microbiota Transplantation ◽  
Controlled Trial ◽  
Similar Efficacy ◽  
Fecal Microbiota ◽  
Efficacy And Safety ◽  
Open Label ◽  
Retention Enema ◽  
Recurrent Clostridium Difficile Infection ◽  
Laboratory Facility ◽  
History Of

Abstract Background Fecal microbiota transplantation (FMT) has shown to be effective for recurrent Clostridium difficile infection (rCDI). However, significant laboratory costs for donor screening and a lack of suitable donors and laboratory facility have restricted the availability of the treatment. In order to expand access to FMT, we have investigated the efficacy of lyophilized FMT, comparing it to the published historical efficacy of frozen FMT in preventing further episodes of CDI in patients with a history of rCDI. This study was designed to be open-labeled to expedite and minimize costs associated with conducting a two-armed randomized controlled trial, given that the efficacy of frozen FMT is known to be 85%. Additionally, using lyophilized FMT offers two major advantages: 1) its prolonged shelf life reduces cost because fewer donors need to be screened; and 2) it can be transported without freezing. Methods This is an open-labeled, prospective study involving 50 patients with a history of 2 or more rCDI who have failed at least 1 course of tapered vancomycin therapy. Eligible patients received 2 lyophilized FMT via retention enema within 8 days of each treatment and were followed for 13 weeks post last FMT to determine efficacy and safety of FMT. Results The efficacy of lyophilized FMTs in preventing further episodes of CDI in patients with rCDI was 80%. The adverse events associated with lyophilized FMT were similar to frozen FMT. Conclusion Lyophilized FMT in treating rCDI showed similar efficacy and safety to frozen FMT. Lyophilized FMT appears to be promising in preventing further episode of CDI and increasing accessibility for patients with rCDI. Disclosures All authors: No reported disclosures.

scholarly journals COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Karin Welén ◽  
Anna K Överby ◽  
Clas Ahlm ◽  
Eva Freyhult ◽  
David Robinsson ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Virus Disease ◽  
Controlled Trial ◽  
Scale Up ◽  
Standard Of Care ◽  
University Hospital ◽  
Ordinal Scale ◽  
Open Label ◽  
Full Protocol ◽  
Exploration Phase

Abstract Objectives The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. Trial design Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. Participants Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. Intervention and comparator Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. Main outcomes The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). Randomisation Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + “standard of care”: “standard of care”). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) Blinding (masking) This is an open-label trial. Numbers to be randomised (sample size) The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. Trial Status The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021. Trial registration Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601, registered June 8, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Comparing the first and second waves of COVID-19 in a tertiary university hospital in Barcelona

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 1197
Author(s):  
Yolima Cossio ◽  
Marta-Beatriz Aller ◽  
Maria José Abadias ◽  
Jose-Manuel Domínguez ◽  
Maria-Soledad Romea ◽  
...  
Keyword(s):  
Tertiary Hospital ◽  
Healthcare Systems ◽  
University Hospital ◽  
Emergency Rooms ◽  
Daily Number ◽  
Patient Demographics ◽  
Significant Difference ◽  
The University ◽  
Hospital Wards ◽  
Second Wave

Background: Hospitals have constituted the limiting resource of the healthcare systems for the management of the COVID-19 pandemic. As the pandemic progressed, knowledge of the disease improved, and healthcare systems were expected to be more adapted to provide a more efficient response. The objective of this research was to compare the flow of COVID-19 patients in emergency rooms and hospital wards, between the pandemic's first and second waves at the University Hospital of Vall d’Hebron (Barcelona, Spain), and to compare the profiles, severity and mortality of COVID-19 patients between the two waves. Methods: A retrospective observational analysis of COVID-19 patients attending the hospital from February 24 to April 26, 2020 (first wave) and from July 24, 2020, to May 18, 2021 (second wave) was carried out. We analysed the data of the electronic medical records on patient demographics, comorbidity, severity, and mortality. Results: The daily number of COVID-19 patients entering the emergency rooms (ER) dropped by 65% during the second wave compared to the first wave. During the second wave, patients entering the ER were significantly younger (61 against 63 years old p<0.001) and less severely affected (39% against 48% with a triage level of resuscitation or emergency; p<0.001). ER mortality declined during the second wave (1% against 2%; p<0.000). The daily number of hospitalised COVID-19 patients dropped by 75% during the second wave. Those hospitalised during the second wave were more severely affected (20% against 10%; p<0.001) and were referred to the intensive care unit (ICU) more frequently (21% against 15%; p<0.001). Inpatient mortality showed no significant difference between the two waves. Conclusions: Changes in the flow, severity and mortality of COVID-19 patients entering this tertiary hospital during the two waves may reflect a better adaptation of the health care system and the improvement of knowledge on the disease.

scholarly journals Efficacy and safety of a centrally acting analgesic flupirtine in primary knee osteoarthritis in comparison to tramadol: a randomized controlled trial

2018 ◽  
Vol 7 (3) ◽  
pp. 381
Author(s):  
Tanmoy Kanti Goswami ◽  
Pradip Kumar Ghoshal ◽  
Avijit Hazra ◽  
Asish Biswas
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Opioid Analgesics ◽  
Womac Score ◽  
Open Label ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Considerable Morbidity

Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder responsible for considerable morbidity, particularly in old age. Flupirtine, a new centrally acting analgesic, is devoid of the adverse effects of NSAIDs and opioid analgesics. In this study author compared the effectiveness and safety of flupirtine with tramadol in knee OA.Methods: An open label, randomized, controlled trial was done with patients of primary knee OA of both sexes, age >50 years. Patients were recruited from Rheumatology OPD of SSKM Hospital. A minimum WOMAC score of 35 was essential for recruitment. Patients with serious comorbidities were excluded. They were treated orally with either flupirtine (100mg thrice daily) or tramadol (50mg thrice daily) for 12 weeks.Results: Ninety patients were recruited and data of 42 on flupirtine and 41 on tramadol were analysed. There was significant improvement in pain, stiffness and physical function compared to baseline in both the groups. However, there was no significant difference between groups at 4, 8 and 12 weeks. Responder rate (50% reduction in pain score from baseline) was 66.67% with flupirtine and 48.78% with tramadol (p = 0.122). Flupirtine caused 4 adverse events compared to 16 with tramadol. However, both the drugs were well-tolerated.Conclusions: The effectiveness of flupirtine in knee OA is comparable to tramadol, while causing minimal adverse effects. Long-term benefits need to be explored.

P-681 Will the hCG trigger dose used for final oocyte maturation in IVF impact endogenous progesterone during the luteal phase? - A randomized controlled trial

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
L Svenstrup ◽  
J Fedder ◽  
S Möller ◽  
D Pedersen ◽  
K Erb ◽  
...  
Keyword(s):  
Oocyte Maturation ◽  
Luteal Phase ◽  
Controlled Trial ◽  
University Hospital ◽  
Final Oocyte Maturation ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
Hcg Trigger ◽  
Group 1

Abstract Study question Is there an association between the hCG dose used for ovulation trigger and the endogenous progesterone production during the luteal phase? Summary answer Increased hCG dosing significantly increased the endogenous progesterone level during the luteal phase. What is known already During the luteal phase of an IVF treatment, the endogenous progesterone (P4) production is negatively impacted due to reduced circulating endogenous LH, caused by negative feed-back of elevated steroids; thus, luteal phase support (LPS) with exogenous P4 remains mandatory in IVF. Apart from inducing final oocyte maturation, the gold standard HCG trigger also functions as an early LPS, boosting P4 production by the corpora lutea (CL). P4 plays a pivotal role for embryo implantation and pregnancy, and an optimal P4 level around peri-implantation seems to be essential for the reproductive outcomes of fresh and frozen/thaw embryo transfer cycles. Study design, size, duration A randomized controlled 4-arm study, including a total of 127 IVF patients, enrolled from January 2015 until September 2019 at the Fertility Clinic, Odense University Hospital, Denmark. Participants/materials, setting, methods IVF patients with ≤ 11 follicles ≥ 12 mm were randomized to four groups. Groups 1-3 were triggered with: 5.000 IU, 6.500 IU or 10.000 IU, hCG, respectively, receiving a LPS consisting of 17-α-hydroxy-progesterone (17α OH P4) to distinguish the endogenous P4 from the exogenous supplementation. Group 4 (control) was randomized to a 6.500 IU hCG trigger and standard LPS. A total of eight blood samples were drawn during the early luteal phase. Main results and the role of chance A total of 94 patients completed the study: 21, 22, 25 and 26 patients in each group, respectively. Baseline characteristics were similar, except for the endogenous LH level and cycle lengths. There were no significant differences between groups regarding ovarian stimulation, number of oocytes and embryos. The median number of follicles ≥ 12mm on the day of trigger was 8.5, resulting in 6.6 oocytes being retrieved. Significant differences in P4 levels were seen at OPU+8 (p &lt; 0.001), OPU+10 (p &lt; 0.001) and OPU+14 (p &lt; 0.001), with positive correlations between P4 level and hCG dose. Groups compared individually showed significant difference in P4 between low and high trigger dose at OPU+4 group 1 and 3 (p = 0.037) and OPU+8 group 1 and 3 (p = 0.007) and between all the three groups around implantation at OPU+6 group 1 and 2 (p = 0.011), group 2 and 3 (p = 0.042) and group 1 and 3 (p &lt; 0.001). Higher P4 levels around implantation were related to follicle count and to pregnancy. After logistic regression analyses there were still significant individual differences between the groups. Limitations, reasons for caution Although patients were randomized and strict inclusion and exclusion criteria were used, the RCT was un-blinded, including a relatively small number of patients. Moreover, for dosing purposes urinary hCG as well as recombinant hCG was used and pharmacokinetics differ. Finally, the P4 level could be influenced by circadian fluctuations. Wider implications of the findings This is the first study to explore dose-responses in circulating P4 after hCG trigger in IVF patients. Increasing the hCG trigger dose increased the endogenous P4 around peri-implantation. Personalizing the hCG trigger dose could be a key point to secure the most optimal P4 mid-luteal phase P4 level. Trial registration number Eudract 2013-003304-39

Single Centre Experience in Patients with Primary Hyperparathyroidism: Sporadic, Lithium-associated and in Multiple Endocrine Neoplasia

2019 ◽  
Vol 128 (10) ◽  
pp. 693-698
Author(s):  
Sabine Dillenberger ◽  
Detlef K. Bartsch ◽  
Elisabeth Maurer ◽  
Peter Herbert Kann
Keyword(s):  
Primary Hyperparathyroidism ◽  
Multiple Endocrine Neoplasia ◽  
University Hospital ◽  
Primary Surgery ◽  
Endocrine Neoplasia ◽  
Single Centre Experience ◽  
Significant Difference ◽  
History Of ◽  
The University

Abstract Purpose It is assumed that primary hyperparathyroidism (pHPT) in Multiple Endocrine Neoplasia (MEN) and lithium-associated pHPT (LIHPT) are associated with multiple gland disease (MGD), persistence and recurrence. The studies purpose was to determine frequencies, clinical presentation and outcome of sporadic pHPT (spHPT), LIHPT and pHPT in MEN. Additional main outcome measures were the rates of MGD and persistence/recurrence. Methods Retrospective analysis of medical records of 682 patients with pHPT who had attended the University Hospital of Marburg between 01–01–2004 and 30–06–2013. All patients were sent a questionnaire asking about their history of lithium medication. Results Out of 682 patients, 557 underwent primary surgery (532 spHPT, 5 LIHPT, 20 MEN), 38 redo-surgery (31 spHPT, 7 MEN), 55 were in follow-up due to previous surgery (16 spHPT, 1 LIHPT, 38 MEN) and 37 were not operated (33 spHPT, 1 LIHPT, 3 MEN). Primary surgeries were successful in 97.4%, revealed singular adenomas in 92.4%, double adenomas in 2.9% and MGD in 3.4% of the cases. Rates of MGD in MEN1 (82.35%) were significantly higher than in spHPT (3.8%), while there was no significant difference between LIHPT (20%) and spHPT. Rates of persistence/recurrence did not significantly differ due to type of surgery (bilateral/unilateral) or type of HPT (spHPT/LIHPT/MEN). Conclusions History of lithium medication is rare among pHPT patients. While MGD is common in MEN1, rates of MGD, persistence or recurrence in LIHPT were not significantly higher than in spHPT.

scholarly journals Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jan Bednarsch ◽  
Zoltan Czigany ◽  
Sven H. Loosen ◽  
Lara Heij ◽  
Lorenz Ruckgaber ◽  
...  
Keyword(s):  
Liver Function ◽  
Primary Endpoint ◽  
Major Hepatectomy ◽  
Controlled Trial ◽  
Liver Volume ◽  
Relative Increase ◽  
Control Group ◽  
Open Label ◽  
Significant Difference ◽  
The Impact

AbstractThe objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7–10 or 14–21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).

scholarly journals Seasonal variability in the incidence of carcinomatous meningitis

2015 ◽  
Vol 122 (3) ◽  
pp. 543-546 ◽  
Author(s):  
Angelos Koutras ◽  
Minas Sakellakis ◽  
Thomas Makatsoris ◽  
Charalabia Psachoulia ◽  
Maria Kardari ◽  
...  
Keyword(s):  
Seasonal Variability ◽  
Warm Season ◽  
Cold Climate ◽  
University Hospital ◽  
Carcinomatous Meningitis ◽  
Warm Climate ◽  
Significant Difference ◽  
The University ◽  
Official Data ◽  
Median Interval

OBJECT The aim of the study was to investigate whether there are seasonal differences in the occurrence of carcinomatous meningitis (CM), with a greater prevalence of the disease in months with higher temperatures. METHODS The authors searched the records of all patients with a diagnosis of CM from 1998 until 2013 at the University Hospital of Patras, Greece. The date of hospitalization was extracted for each patient. The cases were divided into 2 categories depending on the time of CM diagnosis. Based on the official data regarding the annual temperature distribution in this region, the authors divided the patients into 2 groups. The first group consisted of cases diagnosed with CM from October 15 to April 15 (cold climate and shorter daytime duration), whereas the second group comprised patients diagnosed between April 15 and October 15 (warm climate and longer daytime duration). RESULTS Overall, 44 confirmed cases of CM were found. The most common type of malignancy associated with the development of CM was breast cancer (27 patients), while the second most common tumor was lung carcinoma (11 patients). The median interval between the time of initial cancer diagnosis and CM was 4.5 years. Thirty-one patients were diagnosed with CM during the period between April 15 and October 15, while the remaining 13 patients developed CM between October 15 and April 15, a significant difference (p = 0.01). CONCLUSIONS Significantly more patients developed CM during the warm season of the year. To the authors' knowledge, this is the first study to provide evidence for the potential seasonal variability in CM incidence. However, these results should be validated prospectively in larger cohorts.

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