Poziotinib treatment in patients with HER2-positive advanced breast cancer who have received prior anti-HER2 regimens.

PURPOSE: Poziotinib is an irreversible pan-inhibitor of the human epidermal growth factor receptor (HER) that has shown acceptable tolerability and antitumor activity in phase I and II trials in patients with advanced solid tumors. In the present open-label, multicenter phase II study, we demonstrate safety, tolerability, and preliminary efficacy data from two different dosing schedules in patients with HER2-positive advanced breast cancer. PATIENTS AND METHODS: Patients who had received at least two prior HER2-directed therapy lines for advanced disease, received 24 mg poziotinib on an intermittent dosing schedule (cohort 1) or 16 mg poziotinib once daily on a continuous dosing schedule (cohort 2). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), disease control rate (DCR), and time to progression (TTP). Secondary endpoints additionally included safety and pharmacokinetics. RESULTS: A total of 67 patients were enrolled. The ORR was 30% in both groups (p = 0.98). DCR was 60% vs 78% (p = 0.15) and median PFS and TTP were 4.1 vs 4.9 months (both p = 0.30) for cohorts 1 and 2, respectively. The most common treatment related adverse events (AEs) of any grade included diarrhea (88% vs 85%, p = 0.76), rash (88% vs 88%, p = 0.96), and stomatitis (64% vs 56%, p = 0.52), with grade 3-4 diarrhea occurring in 33% vs 32% of patients (p = 0.93) and grade 3-4 rash in 27% vs 35% of patients (p = 0.48) in cohort 1 vs cohort 2, respectively. CONCLUSION: Poziotinib demonstrated evidence of clinical activity in patients with pre-treated HER2-positive advanced breast cancer, although high levels of toxicity may preclude further studies at this time.

Sexually Induced Orgasm to Improve Postpartum Pelvic Floor Muscle Strength and Sexual Function in Primiparous Women After Vaginal Delivery: A Prospective Randomized Two-Arm Study.

BACKGROUND: Postpartum pelvic floor dysfunction is known to affect the quality of life of women and the methods to treat it are more complex with majority requiring training under supervision. AIM: To compare the efficacy of sexually induced orgasm along with Kegels exercises versus Kegels exercises alone as a treatment method to enhance postpartum pelvic floor muscle strength and sexual function in primiparous women undergoing uncomplicated vaginal deliveries. METHODS: The prospective randomized two-arm study was conducted on sexually active primiparous women who had undergone uncomplicated vaginal deliveries. Those with risk factors for female sexual dysfunction and pelvic floor muscle dysfunction were excluded. Participants in Group 1 were advised daily Kegel's exercises, whereas, those in Group 2 were advised to initiate self-initiated/partnered sexual activity-induced orgasms along with daily Kegel's exercises. Their pelvic floor muscle strength on voluntary contraction, ability to relax pelvic floor voluntarily, and sexual function (using FSFI-6) were assessed monthly for 6 months and the analysis was done using G* Power software (© 2021 Heinrich-Heine-Universität Düsseldorf, Germany). MAIN OUTCOME MEASURE: Postpartum pelvic floor strength and sexual function in 2 groups of women under study. RESULTS: The study period was from January 2020 to December 2020. The Group 1 had 26 participants (mean age 29.69 ± 2.2 years) and Group 2 had 29 participants (mean age 30.07 ± 2.57 years). The sexual function as well as ability to relax pelvic floor were significantly better in Group 2 compared to Group 1 at each monthly intervals whereas strength of pelvic floor muscles during voluntary contraction was significantly higher in Group 2 compared to Group 1 at the end of 6 months and it was statistically significant at a P value of .05. CLINICAL IMPLICATIONS: Novel method of using naturally occurring sexually induced orgasms for postpartum pelvic floor rehabilitation can revolutionize postpartum pelvic floor training in women, as it can be practiced at home with ease, along with easily performable Kegel's exercises. STRENGTHS AND LIMITATIONS: Use of prospective randomization and minimization of confounding factors is the strength of the study. The small sample size is the limitation of the study. CONCLUSIONS: Postpartum pelvic floor muscle strength and sexual function in primiparous women who have undergone uncomplicated vaginal deliveries can be significantly improved with the addition of sexually induced orgasm as a therapeutic tool along with physical exercises such as Kegels exercises in these women. Bhat GS, Shastry A. Sexually Induced Orgasm to Improve Postpartum Pelvic Floor Muscle Strength and Sexual Function in Primiparous Women After Vaginal Delivery: A Prospective Randomized Two-Arm Study. J Sex Med 2022;19:1634-1643.

Validation of holding time, a novel tool to assess control over ejaculation in males: A pilot study.

Premature ejaculation (PE) is considered as a disorder of perceived loss of ejaculatory control. However, we cannot objectively estimate ejaculatory control due to the absence of an objective tool to measure it. Hence, we designed a pilot study to validate holding time (HoT), a novel objective tool, hypothesized by us, to measure ejaculatory control in men. The construct validity of this tool to differentiate premature ejaculators from normal ejaculators was also assessed in our sample. The study sample had 10 healthy, sexually active normal ejaculators, and 10 premature ejaculators, who volunteered to participate in the study conducted from May 2020 to April 2021. The mean HoT in normal ejaculators was 120.2 ± 31.7 s and the same in premature ejaculators was 32.9 ± 12.9 s. Both the normal (r = 0.983) as well as premature ejaculators (r = 0.839) had good test-retest reliability. The construct validity of HoT to diagnose PE was good with 90% sensitivity, 91% specificity, 63.8% positive predictive value, and 98.1% negative predictive value to diagnose PE when compared with diagnosis by a standard tool. It could be concluded that HoT successfully measured ejaculatory control in men and differentiated normal ejaculators from the premature ejaculators in the sample studied.

Defining ejaculatory latencies in heterosexual males using novel tools in all types of sexual encounters in multinational population sample.

Research into ejaculatory dysfunction in sexual activities other than penovaginal intercourse is limited due to the absence of well-defined tools to measure ejaculatory latencies in these sexual activities. Our pilot study using Arousal to Ejaculation Time Interval (AETI) and Erection to Ejaculation Time Interval (EETI) as tools to measure ejaculatory latencies in different types of sexual encounters in medical professionals had yielded promising results. Hence, we conducted a similar study using AETI and EETI as tools, measured using stopwatch in healthy, sexually active heterosexual male population in a multinational sample from January 2018 to December 2020. Though mean AETI and EETI differed in different sexual activities, on analysing them across all sexual activities, mean AETI and EETI in normal ejaculators, premature ejaculators and delayed ejaculators were 10.3 ± 5.81 min and 6.8 ± 4.13 min, 4.31 ± 2.98 min and 3.35 ± 3.06 min and 20.9 ± 16.1 min and 16.3 ± 10.6 min respectively. Both AETI and EETI were significantly different from normal to premature as well as normal to delayed ejaculators (p-value < 0.05). It could be concluded that these novel tools can help to measure ejaculatory latencies in sexual activities in heterosexual males.

Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial.

BACKGROUND: Eflapegrastim, a novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open-label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia. MATERIALS AND METHODS: Patients with early-stage breast cancer were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim (6 mg G-CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1. RESULTS: Eligible patients were randomized 1:1 to study arms (eflapegrastim, n = 196; pegfilgrastim, n = 210). The incidence of cycle 1 severe neutropenia was 16% (n = 31) for eflapegrastim versus 24% (n = 51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (-0.148 day) met the primary endpoint of noninferiority (p < .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms. CONCLUSION: These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G-CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN. IMPLICATIONS FOR PRACTICE: Chemotherapy-induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, the efficacy of eflapegrastim was noninferior to pegfilgrastim and had comparable safety. Nevertheless, the risk of CIN remains a great concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.

Time to Orgasm in Women in a Monogamous Stable Heterosexual Relationship.

BACKGROUND: Orgasm in women is a complex phenomenon, and the sparse data about time to orgasm (TitOr) in women are an impediment to the research on this complex phenomenon. AIM: To evaluate the stopwatch measured TitOr in women in a monogamous stable heterosexual relationship. METHODS: The study was conducted through web-based and personal interview using a questionnaire, which addressed the issues related to TitOr. Sexually active women older than 18 years and women in a monogamous stable heterosexual relationship were included in the study. Those with comorbidities such as diabetes, hypertension, asthma, psychiatric illness, sexual dysfunction and those with partners with sexual dysfunction were excluded. The participants reported stopwatch measured TitOr after adequate sexual arousal over an 8-week period. The data analysis was performed using GraphPad software (©2018 GraphPad Software, Inc, USA). OUTCOMES: The outcomes included stopwatch measured average TitOr in women. RESULTS: The study period was from October 2017 to September 2018 with a sample size of 645. The mean age of the participants was 30.56 ± 9.36 years. The sample was drawn from 20 countries, with most participants from India, the United Kingdom, the Netherlands, and the United States of America. The mean reported TitOr was 13.41 ± 7.67 minutes (95% confidence interval: 12.76 minutes-14.06 minutes). 17% of the participants had never experienced the orgasm. Penovaginal intercourse was insufficient to reach orgasm in the majority, in whom it was facilitated by certain positions and maneuvers. CLINICAL IMPLICATIONS: The knowledge of stopwatch measured TitOr in women in real-life setting helps to define, treat, and understand female sexual function/dysfunction better and it also helps to plan treatment of male ejaculatory dysfunction, as reported ejaculatory latency in healthy men is much less than the reported TitOr here. STRENGTHS & LIMITATIONS: Use of stopwatch to measure TitOr and a large multinational sample are the strength of the study. The absence of a crosscheck mechanism to check the accuracy of the stopwatch measurement is the limitation of the study. CONCLUSION: Stopwatch measured average TitOr in the sample of women in our study, who were in a monogamous stable heterosexual relationship, is 13.41 minutes (95% confidence interval: 12.76 minutes-14.06 minutes) and certain maneuvers as well as positions during penovaginal intercourse help achieving orgasm, more often than not. Bhat GS, Shastry A. Time to Orgasm in Women in a Monogamous Stable Heterosexual Relationship. J Sex Med 2020;17:749-760.

A prospective double-blind, randomized, placebo-controlled study to evaluate the efficacy of silodosin 8 mg as an on-demand, reversible, nonhormonal oral contraceptive for males: a pilot study.

PURPOSE: As silodosin 8 mg, used for treating BPH, is known to cause absence of sperms in the ejaculate, its potential as an on-demand, reversible, nonhormonal oral contraceptive for males was assessed in this pilot study. METHODS: In this randomized, double-blind, placebo-controlled pilot study, healthy, sexually active adult male volunteers in a stable sexual relationship with a female partner with proven fertility were recruited. Those using other contraceptive methods were excluded. During the first part of the study, silodosin 8 mg and placebo were crossed over among the randomly assigned two groups of participants and their post-masturbation semen and post-ejaculation urine were analyzed for spermatozoa. During the second part, both groups received silodosin 8 mg 3 h prior to heterosexual vaginal intercourse for 1 year. The primary outcome measure was the number of unintended pregnancies in their female partners. The secondary outcome measure was dropout rate due to adverse events. The clinical trial registry number was CTRI/2017/09/009872. RESULTS: The study period was January 2017 to December 2017 with sample size 63. Reversible azoospermia was noted following silodosin intake during the first part of the study. During the second part, no untended pregnancy was reported. None of the participants dropped out due to adverse events. Four patients were lost to follow-up. CONCLUSIONS: Silodosin 8 mg achieved total reversible azoospermia, hence prevented unintended pregnancies in the female partners of the males who used the drug as an on-demand oral contraceptive.

Association Between Post-Ejaculatory Refractory Time (PERT) and Premature Ejaculation (PE).

INTRODUCTION: Patients with premature ejaculation (PE) often complain of difficulty in having second erection, which is not yet investigated using scientific methodology. AIM: Evaluation of the association between post-ejaculation refractory time (PERT) with PE by comparing PERT in premature ejaculators with their age-matched control subjects. METHODS: After ethical committee approval and written informed consent from the participants were obtained, men in a monogamous stable sexual relationship and reporting PE were recruited into the study. Sexually active, matched control subjects were recruited for comparison. Exclusion criteria were erectile dysfunction, diabetes mellitus, cardiovascular diseases, hypogonadism, psychiatric conditions, instrumentation of the genitourinary tract, genitourinary anomalies, and genitourinary infections. Both the premature ejaculators and their control subjects were evaluated with the PE diagnostic tool before initiation of the study. They were asked to record their IELT and PERT over 4 weeks. The statistical analysis was done to obtain descriptive statistics, namely, mean and SD, paired t-tests, and logistic regression analysis. P < .001 was considered significant. MAIN OUTCOME MEASURE: There was a statistically significant association between prolonged PERT and PE in patients with PE compared with their age-matched control subjects. RESULTS: 102 premature ejaculators and an equal number of matched control subjects were evaluated from January 2016-December 2017. The average PERT in premature ejaculators and control subjects was 330 ± 296.63 minutes and 105.64 ± 98.59 minutes, respectively (P < .0001). Increasing age was associated with increasing PERT. PE was more common in patients when PERT exceeded a threshold of 590 minutes. CLINICAL IMPLICATIONS: Until now, the association between PE and PERT with matched-pair analysis was not reported. Our study addresses this association, which can add a new paradigm in the evaluation and management of PE. STRENGTH & LIMITATIONS: The association between PE and prolonged PERT using a statistically appropriate, adequately powered methodology is the strength of the study. The inability to address the causal association between prolonged PERT and PE because of the paucity of evidence at present is the limitation of the study. We believe that the results of this study could trigger further research into such an association, so the mystery of such an association can be unraveled. CONCLUSIONS: The association between prolonged PERT and PE, as seen in our study, is a finding, that needs further research to establish a causal association. However, reporting such an association is necessary because it is contrary to the present understanding. Bhat GS, Shastry A. Association Between Post-Ejaculatory Refractory Time (PERT) and Premature Ejaculation (PE). J Sex Med 2019;16:1364-1370.

Environmentally-friendly thermal and acoustic insulation materials from recycled textiles.

Continuing increase in energy consumption and environmental pollution are some of the main challenges of the 21st century. One of the approaches to overcome these challenges is to increase the use of recycled materials and environmentally-friendly approaches to manufacturing. Thermal and acoustic insulation in buildings and transport vehicles from recycled textiles can play an important role in energy savings and reduction of environmental pollution. Textiles contribute a significant amount to the waste stream since most of these valuable fiber products are discarded after use. These discarded but valuable textiles can be recycled to produce several products including thermal and acoustic insulation materials. In this paper, a comprehensive review of the current state of textile waste generation and its environmental effects, and present progress of using industrial and post-consumer recycled textiles in insulation materials is provided. Mechanism of acoustic and thermal insulation materials of textile fibers are also reviewed. Existing research of some textile waste used as building insulation materials, method of conversion of textile waste into building insulation materials, comparative analysis of different insulation materials and life cycle assessment of textile fibers are assessed.

Improving mechanical properties of carbon nanotube fibers through simultaneous solid-state cycloaddition and crosslinking.

Individual carbon nanotubes (CNTs) exhibit exceptional mechanical properties. However, difficulties remain in fully realizing these properties in CNT macro-assemblies, because the weak inter-tube forces result in the CNTs sliding past one another. Herein, a simple solid-state reaction is presented that enhances the mechanical properties of carbon nanotube fibers (CNTFs) through simultaneous covalent functionalization and crosslinking. This is the first chemical crosslinking proposed without the involvement of a catalyst or byproducts. The specific tensile strength of CNTFs obtained from the treatment employing a benzocyclobutene-based polymer is improved by 40%. Such improvement can be attributed to a reduced number of voids, impregnation of the polymer, and the formation of covalent crosslinks. This methodology is confirmed using both multiwalled nanotube (MWNT) powders and CNTFs. Thermogravimetric analysis, differential scanning calorimetry, x-ray photoelectron spectroscopy, and transmission electron microscopy of the treated MWNT powders confirm the covalent functionalization and formation of inter-tube crosslinks. This simple one-step reaction can be applied to industrial-scale production of high-strength CNTFs.

Use of a stopwatch to measure ejaculatory latency may not be accurate among Indian patients.

INTRODUCTION: Although the use of a stopwatch is recommended to record intravaginal ejaculatory latency time (IELT) for premature ejaculation, there is no Indian literature which assesses the reliability of this method among our patients. Hence, we assessed the accuracy of stopwatch-measured IELT and compared it with other methods such as number of thrusts and self-assessed IELT in an Indian context. METHODS: Between January 2015 and December 2015, couples with premature ejaculation (PE) confirmed with the Premature Ejaculation Diagnostic Tool were enrolled in this study. They were asked to report self-assessed IELT for the first 2 weeks, number of thrusts before ejaculation following vaginal penetration for the next 2 weeks, and stopwatch-clocked IELT for the last 2 weeks. At each 2-week interval, the couples answered erectile/ejaculatory performance anxiety index questionnaire (EPAI). The data were analyzed at the end of 6 weeks. RESULTS: A total of 42 couples with an average married life of 5.53 years were included in the study. Average stopwatch-clocked IELT was almost 1 min more than the self-reported IELT, which was statistically significant. The average number of thrusts reported was 6.31. Anxiety on the EPAI scale was maximum while using stopwatch to measure IELT. CONCLUSION: Use of stopwatch to clock the IELT does not appear to represent true IELT in Indian patients. Self-assessed IELT correlated more accurately with symptoms of PE.

A Phase IIb, Multicenter, Open-Label, Safety, and Efficacy Study of High-Dose, Propylene Glycol-Free Melphalan Hydrochloride for Injection (EVOMELA) for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation.

Autologous stem cell transplantation (ASCT) after high-dose melphalan conditioning is considered a standard of care procedure for patients with multiple myeloma (MM). Current formulations of melphalan (eg, Alkeran for Injection [melphalan hydrochloride]; GlaxoSmithKline, Research Triangle Park, NC, USA) have marginal solubility and limited chemical stability upon reconstitution. Alkeran requires the use of propylene glycol as a co-solvent, which itself has been reported to cause such complications as metabolic/renal dysfunction and arrhythmias. EVOMELA (propylene glycol-free melphalan HCl; Spectrum Pharmaceuticals, Inc., Irvine, CA, USA) is a new i.v. melphalan formulation that incorporates Captisol (Ligand Pharmaceuticals, Inc., La Jolla, CA, USA), a specially modified cyclodextrin that improves the solubility and stability of melphalan and eliminates the need for propylene glycol. This new formulation has been shown to be bioequivalent to Alkeran. EVOMELA (200 mg/m(2)) was administered as 2 doses of 100 mg/m(2) each in a phase IIb, open-label, multicenter study to confirm its safety and efficacy as a high-dose conditioning regimen for patients with MM undergoing ASCT. At 5 centers, 61 patients (26 women) with a median age of 62 years (range, 32-73) were enrolled. All patients achieved myeloablation with a median time of 5 days post-ASCT, and all successfully achieved neutrophil and platelet engraftment with median times of 12 days post-ASCT and 13 days post-ASCT, respectively; treatment-related mortality on day 100 was 0%. Overall response rate (according to independent, blinded review) was high (100%), with an overall complete response rate of 21% (13% stringent complete response; 8% complete response) and overall partial response rate of 79% (61% very good partial response; 18% partial response). The incidence of grade 3 mucositis and stomatitis was low (10% and 5%, respectively) with no grade 4 mucositis or stomatitis reported (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events). Based on investigators' assessment of mucositis using the World Health Organization (WHO) oral toxicity scale, 75% of patients had a shift in mucositis score from WHO grade 0 at baseline to a higher grade on study, of which 13% of patients reported WHO grade 3 as the worst post-treatment mucositis over the course of the study; there were no reports of WHO grade 4 mucositis during the study. This study confirms the efficacy and acceptable safety profile of EVOMELA, a new propylene glycol-free melphalan formulation, as a high-dose conditioning regimen for ASCT in patients with MM.

A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma.

Belinostat is a pan-histone deacetylase inhibitor with antitumour and anti-angiogenic properties. An open label, multicentre study was conducted in patients with peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) who failed ≥1 prior systemic therapy and were treated with belinostat (1000 mg/m(2) intravenously ×5 d of a 21-d cycle). The primary endpoint was objective response rate (ORR). Patients with PTCL (n = 24) had received a median of three prior systemic therapies (range 1-9) and 40% had stage IV disease. Patients with CTCL (n = 29) had received a median of one prior skin-directed therapy (range 0-4) and four prior systemic therapies (range 1-9); 55% had stage IV disease. The ORRs were 25% (PTCL) and 14% (CTCL). Treatment-related adverse events occurred in 77% of patients; nausea (43%), vomiting (21%), infusion site pain (13%) and dizziness (11%) had the highest incidence. Treatment-related serious adverse events were Grade 5 ventricular fibrillation; Grade 4 thrombocytopenia; Grade 3 peripheral oedema, apraxia, paralytic ileus and pneumonitis; and Grade 2 jugular vein thrombosis. Belinostat monotherapy was well tolerated and efficacious in patients with recurrent/refractory PTCL and CTCL. This trial was registered at www.clinicaltrials.gov as NCT00274651.

Assessment of pain and activity using an electronic pain diary and actigraphy device in a randomized, placebo-controlled crossover trial of celecoxib in osteoarthritis of the knee.

OBJECTIVE: The primary goal was to determine whether a composite measure of pain and activity is a more responsive assessment of analgesic effect than pain alone or activity alone in patients with osteoarthritis (OA) of the knee. DESIGN: We conducted a randomized, double-blind, placebo-controlled, 2-period, crossover study of celecoxib vs. placebo in subjects with chronic pain due to knee OA. Patients with knee OA and baseline pain intensity score ≥4 on a 0-10 numerical rating scale (NRS) before each period were randomized. Pain endpoints included in-clinic pain score (24-hour and 1-week recall), daily paper diary pain score, current pain on an electronic pain diary (each on NRS), and WOMAC pain subscale. Activity measures included WOMAC function subscale and actigraphy using a device. Three composite pain-activity measures were prespecified. RESULTS: Sixty-three patients were randomized and 47 completed the study. The WOMAC pain subscale was the most responsive of all five pain measures. Pain-activity composites resulted in a statistically significant difference between celecoxib and placebo but were not more responsive than pain measures alone. However, a composite responder defined as having 20% improvement in pain or 10% improvement in activity yielded much larger differences between celecoxib and placebo than with pain scores alone. Actigraphy was more responsive than the WOMAC function scale, possibly due to lower placebo responsiveness. CONCLUSION: We have identified composite pain-activity measures that are similarly or more responsive than pain-alone measures in patients with OA. Further research is warranted to determine the optimal method for computing these composites.

Prospective, randomized, placebo-controlled, two-arm study to evaluate the efficacy of coadministration of garlic as a hydrogen sulfide donor and tadalafil in patients with erectile dysfunction not responding to tadalafil alone - A pilot study.

OBJECTIVE: The objective is to evaluate the efficacy of coadministration of garlic (as a hydrogen sulfide [H2S] donor) and tadalafil for patients with ED using a placebo-controlled, prospective, randomized, two-arm pilot study in patients responding poorly to tadalafil alone. MATERIALS AND METHODS: The patients with complaints of ED (with normal penile Doppler) who failed to maintain sustained improvement in erectile function with tadalafil were recruited after excluding those with comorbidities. The study sample was randomized into two groups. Group A received garlic 5 g twice a day orally and Group B received a placebo twice daily orally for 4 weeks. Both groups continued tadalafil 5 mg in the night for 4 weeks. Their erectile function was assessed at the beginning and at the end of 4 weeks using the International Index of Erectile Function (IIEF-EF), erectile function domain and compared. A value of P ≤ 0.05 was considered statistically significant. RESULTS: Nineteen patients in Group A (mean age 37.5 ± 10.6 years) and 16 patients in Group B (mean age 39.6 ± 9.6 years) participated in the pilot study conducted from May 2022 to August 2022. The participants treated with garlic (as an H2S donor) as a coadministrant had statistically significant improvement in IIEF-EF score (P ≤ 0.0001) at the end of 4 weeks compared to placebo. CONCLUSIONS: Garlic (as an H2S donor) as adjunctive therapy was beneficial in our study participants responding poorly to tadalafil alone.

Prospective randomized study to evaluate and compare the post-procedural sexual function in patients undergoing semi-rigid ureterorenoscopy for distal ureteric stones in three different operating room settings.

Objective: To evaluate and compare the effect of semi-rigid ureterorenoscopy on post-procedural sexual function with three different operating room settings. Methods: In this prospective randomized study, consecutive sexually active patients with normal pre-operative sexual function undergoing uncomplicated semi-rigid ureterorenoscopy for distal ureteric stones were randomized into three groups, with three different operating room settings. Procedure-related anxiety and sexual function were assessed pre-operatively using Amsterdam Preoperative Anxiety and Information Scale and Brief Sexual Function Inventory (in males) and Female Sexual Function Index-6 (in females), respectively. All the participants were stented following the procedure, and the stent was removed after 3 weeks. Post-procedural sexual function and general discomfort were assessed and compared between three groups at 1 week, 3 weeks, and 12 weeks. The effect of surgery-related anxiety, preoperative sexual function, age, and general discomfort (including stent-related discomfort) on post-procedural sexual function were analyzed using multiple regression analysis. A p-value of less than 0.05 was considered statistically significant. Results: Totally, 327 eligible patients were randomized into three groups. The group of patients who underwent the procedural with a screen separating the operating area from the patient vision, while the patient could watch the endoscopy through a separate monitor, had better post-procedural sexual function compared to those who had total vision of the operating area as well as to those whose eyes were blocked. This difference was statistically significant. This post-procedural reduction in sexual function could not be attributed to in situ stent alone. Conclusions: Our study showed that semi-rigid ureterorenoscopy can have significant negative effect on sexual function, which can be reduced with proper preoperative counseling and an ideal operating room settings.

Synthesis, Activation, and Characterization of Carbon Fiber Precursor Derived from Jute Fiber.

Activated carbon (AC) fiber is a carbonaceous material with a porous structure that has a tremendous scope of application in different fields. Conventionally, AC is derived from fossil fuel-based raw materials like polyacrylonitrile (PAN) and pitch. In this work, AC was synthesized from eco-friendly, renewable, and ubiquitous jute fiber. Systematically, the jute fiber was washed and pretreated with NaOH. Raw jute and NaOH-treated jute were carbonized/pyrolyzed at 500 °C for 1 h in presence of N2 gas. The carbonized carbon was activated with H3PO4 and KOH and again pyrolyzed at 650 °C for 1.5 h maintaining the inert condition. The different features of activated carbons were characterized with field emission-scanning electron microscope, energy-dispersive X-ray spectroscopy (EDX), transmission electron microscopy (TEM), X-ray diffraction (XRD), and thermogravimetric analysis. The average yield of carbonized and activated carbons was recorded at 19 and 13.8%, respectively. The scanning electron microscopic images confirmed a honeycomb-like porous structure. It was observed that KOH-activated carbon exhibited a more porous structure than the H3PO4-activated carbons. The average pore diameter of activated carbons was noted to be 1.3 µm. The pore density was higher in case of KOH-activated carbons accounting for 2.15 pore/µm. The EDX analysis showed that H3PO4-activated carbons had more than 90% carbon atoms indicating a significant carbon content. The TEM images revealed that AC particles were in the nanoscale range. The average particle sizes of H3PO4-activated carbon and KOH-activated carbon were 36.38 and 32.8 nm, respectively. The XRD study demonstrated the highly disordered and low level of crystallinity of AC. It was detected that the AC showed much higher thermal resistance than the jute fiber. The H3PO4-activated carbon obtained from NaOH-treated jute remained at 84% even after 500 °C. A higher thermal resistance was achieved with H3PO4-activated carbon since it contains 0.56% phosphorus, which was confirmed by EDX investigation. It was found that a higher carbon yield was obtained from NaOH-treated jute. The porous structure of the material showed that it could be used as an adsorbent. Due to its high thermal stability, it is recommended for flame retardants and heat insulation applications as well.

Evaluation of environmental impacts of cotton polo shirt production in Bangladesh using life cycle assessment.

The textile industry is widely considered as one of the most pollutant-releasing sectors globally. As the world is moving toward sustainability, it is essential to thoroughly assess how a textile product affects the environment. The aim of this study is to investigate the environmental impact of textile manufacturing in Bangladesh using life cycle assessment (LCA) method. A cradle-to-gate LCA was conducted to produce 1000 units of cotton polo shirts following ISO 14040 standards. LCA was also conducted for each final product at every manufacturing stage of cotton polo shirt, including the production of 1000 kg of cotton fibers, 1000 kg of yarn, 1000 kg of grey fabrics, 1000 kg of dyed-finished fabrics, and finally, assembling of 1000 pieces of polo shirts. Inventory analysis revealed that for producing 1000 pieces of polo shirts, 0.12 hector of land, 363.89 kg of cotton fiber, 324.84 kg of yarn, 320.45 kg of knitted fabric, and 299.5 kg of dyed-finished fabrics were required. The study also found that 1550.9 kWh of electricity, 15.47 L of diesel, and 72.54 m3 of natural gas were needed to produce 1000 pieces of polo shirts. The potential environmental impacts were categorized into 12 different types based on the CML 2001 method and calculated using openLCA 2.0 software. The outcomes of LCA revealed considerable environmental impacts in different categories during manufacturing of cotton polo shirts in Bangladesh. For example, the global warming potential (GWP) associated with the manufacturing of 1000 pieces of polo shirts was 1345.97 kg CO2-eq. Among several production stages of polo shirts, the highest contributor of GWP was dyeing section (38.36 %), followed by cotton fiber production (29.32 %) and yarn manufacturing (18.92 %). The obtained data also revealed that for cultivating cotton fibers, manufacturing of yarn and grey fabrics, and finally dyeing-finishing of same quantity fabric (1000 kg), the GWP were 1084.41 kg CO2-eq, 783.67 kg CO2-eq, 145.88 kg CO2-eq, 1723.88 kg CO2-eq, 314.94 kg CO2-eq, respectively. The outcome of the impact assessment will be crucial for decision-making when it comes to taking remedial actions to lessen negative environmental consequences for the sustainable development of textile industry in Bangladesh.

Carbon nanofibers based carbon-carbon composite fibers.

Textile grade polyacrylonitrile (PAN) was used as a precursor material for carbon fiber preparation. E-beam irradiated polyacrylonitrile grafted carbon nanofibers were dispersed in polyacrylonitrile solution (dissolved in dimethyl formamide). Carbon nanofibers (CNF) infused polyacrylonitrile solution was wet spun on a lab-scale wet-spinning setup to form 50 to 70 µm diameter fibers with 3.2 wt.% CNF-PAN, 6.4 wt.% CNF-PAN, and neat PAN. Precursor fibers were characterized for thermal, mechanical and morphological properties using various techniques. Drawing the precursor fibers further enhanced polymer chain orientation and coalesced the voids, enhancing tensile strength and modulus by more than 150% compared to those of the undrawn fibers. Precursor composite fibers on carbonization showed enhanced strength, compared to that of pristine PAN fibers, by four times and stiffness by 14 times. The carbon-carbon composite fibers were further characterized with SEM/FIB, XRD and tensile strength. The property improvements were dependent on the uniform distribution of carbon nanofibers, and surface modification of carbon nanofibers further enabled their dispersion in the composite fibers. Furthermore, 3.2 wt.% CNFs in PAN fibers showed maximum improvement in properties compared to 6.4 wt.% CNF in PAN fibers, indicating that the property enhancements go through a maximum and then drop off due to challenge in getting uniform distribution of nanofibers.