Comparison of Sexual Function after Thermal Ablation Versus Loop Electrosurgical Excision Procedure (LEEP) for Cervical Intraepithelial Neoplasia (CIN 2 and 3): A Randomized Controlled Trial.

BACKGROUND: The prevention of cervical cancer can be achieved by treating high-grade cervical precancerous lesions. Treatment options for cervical precancer include excisional procedures, and ablation treatments. Despite the long pre-invasive course of the disease, literature addressing sexual function post-treatment for cervical pre-invasive lesions is scarce. This study aims to bridge this gap and assess the sexual function and the acceptability, efficacy, safety, and complications of loop electrosurgical excision procedure (LEEP) versus thermal ablation. METHODS: The prospective open-label randomized controlled trial recruited women aged 22-55 with histologically confirmed Cervical Intraepithelial Neoplasia (CIN) 2 and 3 lesions. Participants were randomly allocated to either thermal ablation or LEEP. All cases were followed up with a Pap smear at three- and six-months post treatment. Sexual health assessments were conducted using a questionnaire at baseline and 3 months post-procedure. Secondary outcome measures included comparison of acceptability, pain, and side effects between the two treatment measures. RESULTS: Out of 1356 screened cases, 60 were included in the study and randomized in two groups. The groups had similar baseline characteristics. Duration of LEEP was longer than thermal ablation (25.33 vs. 20.67 minutes), with higher pain reported 10 minutes post-procedure in the LEEP group. Three months post-procedure, both groups showed comparable acceptability and symptom relief. Sexual function parameters significantly improved in the thermal ablation group compared to LEEP, including satisfaction, desire, lubrication, flexibility, and ability to reach climax. CONCLUSION: LEEP and thermal ablation are effective treatments for CIN with similar efficacy at 6 months. Thermal ablation demonstrated advantages in procedure time and post-procedural pain but exhibited varying effects on sexual function, improving satisfaction and desire. In contrast, LEEP showed a decrease in satisfaction and potential alterations in lubrication and flexibility. Larger-sample, longer-term studies are recommended for further insights.

Prevalence of Stunting and its Biosocial Determinants among Young Children Enrolled at Urban Anganwadi Centers in Rishikesh, Uttarakhand.

Background: Stunting is a significant public health problem in childhood in developing countries. Sustainable Developmental Goals have mandated that each country reduce stunting by 50% by 2030. However, despite various nutrition and health programs, India still faces a massive burden of stunting. With the increasing urbanization in the country and its typical challenges related to health and nutrition, chronic malnutrition is a massive problem in urban areas, especially among people in the lower wealth quintile. Hence, current study has attempted to estimate the prevalence of stunting among children (0-6 years) and its determinants. Methodology: A cross-sectional study was conducted in the Urban Anganwadi centers of Rishikesh, Uttarakhand, for 6 months, from December 2021 to May 2022. Three hundred ten children from 13 selected Anganwadi centers were included using random sampling. Data were collected using a semi-structured validated and pretested questionnaire using Epicollect 5.0. Data were analyzed using the SPSS 23.0 version to estimate the prevalence of stunting and associated risk factors. Results: Out of 310 participants, 71 (22.9%) were stunted. Female children were slightly more stunted (24.7%) than males (21.1%). Maximum stunting (33.4%) was observed among children in the 5-6-year age group, and children with higher birth order were much more stunted. Stunting was reported more in children who were breastfed on demand (33.8%) than those fed every 2 hours (19.3%). Conclusion: Stunting prevalence in urban areas of Rishikesh is 22.9%, which is almost similar to the state average of 24.3% for urban areas; however, it was higher in comparison to the SDG 2030 global target of ending malnutrition of all forms. Stunting was significantly associated with feeding on demand and eating frequency less than twice a day.

Effect of 4-day Online Breath Meditation Workshop on Ballistocardiography-based Sleep and Cardiac Health Assessments among Medical Professionals of a Tertiary Care Hospital in North India during COVID-19.

BACKGROUND: Medical professionals (MPs) are facing stress, sleep deprivation, and burnout due to pandemic-related high patient inflow and consistent work shifts. Yoga and meditation are feasible, cost-effective, evidence-based, and well-accepted tools having multifold mental and physical health benefits. DESIGN: In this ongoing open-label single-arm trial, we assessed changes in sleep, heart rate variability (HRV), and vitals before and after a 4-day online breath meditation workshop (OBMW) among 41 MPs at a tertiary care hospital in northern India during COVID-19 pandemic. METHODS: Outcomes were assessed at baseline and after the 4-day workshop using a ballistocardiography-based contactless health monitoring device. The workshop was conducted online. Two participants were excluded due to a lack of adherence. RESULTS: A highly significant increase was seen in total sleep duration (p = 0.000) and duration of deep sleep (p = 0.001), rapid eye movement (REM) sleep (p = 0.000), and light sleep (p = 0.032). HRV outcomes of the standard deviation of normal-to-normal R-R intervals (SDNN) and root mean square of successive differences between adjacent normal heartbeat (RMSSD) also improved significantly (p = 0.000) while heart rate reduced significantly (p = 0.001). No significant change was observed in breath rate, total time awake, or in the low-frequency by high-frequency (LF/HF) spectrum of HRV. CONCLUSION: Four days of OBMW improved sleep and HRV among MPs, strengthening the fact that yoga and meditation can help induce psychophysical relaxation and prove to be an effective tool to combat stress and sleep deprivation. As the stakeholders in patient care, that is, MPs are healthy, it will further improve patient care and reduce the chance of medical errors.

Fear, Anxiety, Stress, and Depression of Novel Coronavirus (COVID-19) Pandemic Among Patients and Their Healthcare Workers - A Descriptive Study.

PURPOSE: Disease pandemics are known to cause psychological distress. The ensuing mental health issues are not only restricted to the patients and their relatives/friends but affect the healthcare workers (HCWs) as well. Our study aims to assess these psychological trends during the COVID-19 pandemic between the two most affected population groups, that is, patients and frontline healthcare workers. PATIENTS AND METHODS: A survey questionnaire, including scales to assess fear, anxiety, stress, depression - PSS 10, and DASS 21, was distributed and sent to all COVID-19 suspected/confirmed individuals and healthcare workers at a tertiary care center along with a second visit after 14 days of answering the first questionnaire and this continued as follow-up. Data were analyzed with the SPSS version 23 using various tests of significance. RESULTS: In the community, COVID-19 patients in the age group 41-50 with respiratory tract symptoms and those who were home isolated/quarantined experienced a greater tendency of mental health problems. Healthcare workers posted in COVID-19 designated areas of the hospital displayed higher levels of stress, anxiety, and depression. CONCLUSION: The high degree of uncertainty associated with novel pathogens has a profound effect on the psychological state of suspected/confirmed cases as well as healthcare workers. Within the community, individuals suspected of having COVID-19 display a significant mental health burden, while HCWs also experience an unprecedented amount of stress, anxiety, depression and fear during such enduring situations.

Antiviral Combination Clinically Better Than Standard Therapy in Severe but Not in Non-Severe COVID-19.

PURPOSE: Definitive antiviral treatment is not available for COVID-19 infection, with the exception of remdesivir, which still evokes many doubts. Various monotherapy or combination therapies with antivirals or other agents have been tried. The present study aims to evaluate the therapeutic potential of hydroxychloroquine and lopinavir-ritonavir in combination with ribavirin in mild-severe COVID-19. PATIENTS AND METHODS: A single-center, open-label, parallel-arm, stratified randomized controlled trial evaluated the therapeutic potential of combination antiviral therapies. Enrolled patients in the severe category were randomized into three groups: (A) standard treatment, (B) hydroxychloroquine+ribavirin+standard treatment, or (C) lopinavir+ritonavir+ribavirin+standard treatment; while the non-severe category comprised two groups: (A) standard treatment or (B) hydroxychloroquine+ribavirin. Combination antivirals were given for 10 days and followed for 28 days. The primary endpoints were safety, symptomatic and laboratory recovery of organ dysfunctions, and time to SARS-CoV-2 RT-PCR negative report. RESULTS: In total, 111 patients were randomized: 24, 23, and 24 in severe categories A, B, and C, respectively, and 20 in each of the non-severe groups. Two patients receiving ribavirin experienced drug induced liver injury, and another developed QT prolongation after hydroxychloroquine. In the severe category, 47.6%, 55%, and 30.09% in A, B, and C groups, respectively, showed symptomatic recovery, compared to 93.3% and 86.7% in A and B groups, respectively, in the non-severe category at 72 hours (P>0.05). CONCLUSION: Though the results failed to show statistical superiority of the antiviral combination therapies to that of the standard therapy in both the severe and non-severe categories in symptomatic adult patients of COVID-19 due to very small sized trial, clinically hydroxychloroquine+ribavirin therapy is showing better recovery by 7.4% than standard therapy in the former category. However, results do indicate the benefit of standard therapy in the non-severe category by 6.6%. Furthermore, the dose of ribavirin needs to be reconsidered in the Indian population.

Men's involvement in women's reproductive health: A community-based mixed-method study.

BACKGROUND: Female dominion in family planning has underestimated men's participation in female reproductive health. OBJECTIVE: To assess male's involvement in female reproductive health with regard to safe motherhood and family planning and to explore the factors influencing the participation of males in reproductive and sexual health. METHODS: A community-based, mixed-method study was conducted from May 2018 to January 2019 in urban Puducherry. All eligible couples with at least one child were included. Two-stage random sampling with a sample size of 373 was considered. Data were collected separately among spouses using epi-collect 5 and analyzed using the SPSS software version 23. Qualitative data were obtained using free-listing and pile-sorting techniques, analyzed in Anthropac software. RESULTS: 39.9% had planned their pregnancy. Only 33.5% of couples had decided together with the place of delivery. 76.7% of wives wish to involve their husbands in family planning. 88.2% of wives and 89.8% of husbands chose tubectomy as the preferred method of permanent contraception. Both husband and wife were involved in child rearing among 60.3% of participants. The changing dynamics of society, health-care provider initiative, and literacy level favored males' involvement in females' reproductive health. CONCLUSION: Men were involved in planning the pregnancy, supporting their spouse by accompanying for antenatal checkups, discussing with their partners about the complications faced during pregnancy. Health care facility-related factors and faith were perceived as hindering factors for males' involvement in reproductive health by either gender.

Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial): A structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: 1. To compare the safety and efficacy of Hydroxychloroquine with Ribavirin and standard treatment in patients with non-severe COVID-19 infection 2. To compare the safety and efficacy of standard treatment, Lopinavir-ritonavir with Ribavarin, and Hydroxychloroquine with Ribavirin in patients with severe COVID-19 infection TRIAL DESIGN: The study is an Open label, Parallel arm design, stratified randomised controlled trial. Patients will be categorised as non-severe or severe based on predefined criteria. Those who satisfy all inclusion criteria and no exclusion criteria in the respective categories, will be randomly assigned to one of the three treatment groups in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category. PARTICIPANTS: The trial will be undertaken in a tertiary care center of the country where both Covid and non-Covid patients are getting treated. All patients who are confirmed positive and admitted will be screened for the eligibility criteria and will be enrolled in the study after a written informed consent. Patients will be categorised as non-severe or severe based on predefined criteria. INCLUSION CRITERIA (ALL REQUIRED): 1. Age ≥18 years at time of participation in the study 2. Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3. Symptomatic (severe or non-severe) Covid-19 disease 4. Willingness of study participant to accept randomization to any assigned treatment arm EXCLUSION CRITERIA: 1. Use of medications that are contraindicated with Lopinavir/Ritonavir, Hydroxychloroquine/Chloroquine, or Ribavirin and that cannot be replaced or stopped 2. Patient already on antiretroviral therapy with Lopinavir-Ritonavir based regimen or on Hydroxychloroquine/Chloroquine or on Ribavirin 3. Any known contraindication to test drugs such as retinopathy and QT prolongation 4. Known allergic reaction or inability to take orally of Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine, Ribavarin 5. Pregnant or breastfeeding females 6. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within 30 days prior to participation in the present study or want to participate after enrolment INTERVENTION AND COMPARATOR: Two therapeutic interventions for non-severe category and three for severe category as described below NON-SEVERE TREATMENT ARMS (NS-GROUP): Treatment Arm Drug A Standard Treatment (STNS) B Hydroxychloroquine 400 mg twice on first day followed by 400 mg per oral daily for 10 days + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STNS) Standard Treatment for non-severe cases (STNS): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Hydration, Proper Nutrition, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1. SEVERE GROUP TREATMENT ARMS (S-GROUP): Treatment Arm Drug A Standard Treatment (STs) B Hydroxychloroquine 400mg BD on day1 followed by 400 mg once daily + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STs) C Lopinavir(200mg) + Ritonavir (50mg) two tablets twice daily+ Ribavirin (1.2g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STs)6 Standard Treatment for severe patients (STs): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Fluid Therapy, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Oxygen supplementation (As required), Invasive ventilation (As required), Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients), Vasopressor support, Renal-replacement therapy, Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1. MAIN OUTCOMES: Primary endpoints: (1) Time to Clinical recovery (TTCR) defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, oxygen saturation, and alleviation of cough, sustained for at least 72 hours. (2) Time to SARS-CoV-2 RT-PCR negative in upper respiratory tract specimen, time to laboratory recovery of each organ involvement. Secondary Endpoints: All causes mortality, Frequency of respiratory progression (defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support), time to defervescence (in those with fever at enrolment), frequency of requirement for supplemental oxygen or non-invasive ventilation, frequency of requirement for mechanical ventilation, frequency of serious adverse events as per DAIDS table grade of severity. Outcomes are monitored for 28 days from the time of enrolment into the study OR until the patient is discharged or death whichever is longer. RANDOMIZATION: The randomization will be done using a secured central computer-based randomization using a secure website using a central, computer-based randomisation program in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category. BLINDING (MASKING): This is an open labelled study i.e. Study assigned treatment will be known to the research team, the investigators and participants. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Since it is an exploratory trial as COVID-19 being a new disease, all patients who came under the purview of the inclusion criteria within the study period (5 months duration of the recruitment period of the total 6 months duration of the study i.e. from the month of June, 2020 to October 2020) and who have consented for the study will be included. TRIAL STATUS: Protocol version:1.0 Recruitment start: June 3rd, 2020 (Ongoing) Recruitment finish (expected): October 31st, 2020 TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI): CTRI/2020/06/025575 . Registration on 03 June 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.