Effect of comprehensive rehabilitation on apnea hypopnea index in patients with obstructive sleep apnea: a protocol for randomized controlled trial.

PURPOSE: The aim of this study is to investigate the effect of comprehensive rehabilitation on apnea hypopnea index (AHI) in patients with obstructive sleep apnea (OSA). METHODS: Patients diagnosed with OSA and meeting the eligibility criteria will be randomly allocated in the groups. The experimental group will receive comprehensive rehabilitation, and the control group will receive myofunctional therapy. CPAP will be continued by all the participants. Both the groups will receive the interventions for 12 weeks. The primary outcome measures are AHI and Epworth Sleepiness Scale (ESS), and secondary outcomes are Pittsburg Sleep Quality Index (PSQI), Oxygen Desaturation Index (ODI), Snoring Index (SI), Manual Assessment of Respiratory Motion (MARM), Breath Hold Test (BHT), and Self Evaluation of Breathing Questionnaire (SEBQ). The outcomes will be assessed at baseline and at the end of 12 weeks. A follow-up will be taken at the end of 24 weeks. Power analysis suggests that enrollment of 118 patients will required. Repeated measures ANOVA will be used to analyze the effect of the intervention. CONCLUSION: By performing this research, we may develop insights on a novel comprehensive approach for treatment of patients with OSA. TRIAL REGISTRATION: CTRI/2023/10/058486.

Fixed dose combination of capecitabine and cyclophosphamide in metastatic breast cancer: Results from THE ENCLOSE phase 2/3 randomized multicenter study.

AIM: To evaluate pharmacokinetics, efficacy and safety of fixed-dose combination (FDC) of oral capecitabine + cyclophosphamide in metastatic breast cancer (MBC) patients progressing after anthracycline and/or taxane chemotherapy. METHODS: In this prospective, adaptive, phase-2/3, open-label study (CTRI/2014/12/005234), patients were randomized (1:1:1) to three FDC doses (doses/day: D1, capecitabine + cyclophosphamide 1400 mg + 60 mg; D2, 1800 mg + 80 mg; D3, 2200 mg + 100 mg) for 14 days, in 21-day cycles. In Part-I, multiple-dose pharmacokinetics and optimal dose(s) were evaluated with futility analysis. Group(s) with <3 responders based on best overall response rate (BOR, complete response [CR]+partial response [PR]), were discontinued. Efficacy (BOR, disease control rates [DCR; CR + PR + stable disease]) and safety of optimal dose(s) were evaluated in Part-II. RESULTS: Of 66 patients (n = 22/group) in Part-I, pharmacokinetics (D1 = 7/22, D2 = 9/22, D3 = 8/22) showed dose-proportionality for cyclophosphamide and greater than dose-proportionality for capecitabine. Modified intent-to-treat (mITT) analysis showed BOR of 7.14% (1/14) in D1 (discontinued), and 22.22% (4/18) each in D2 and D3, respectively. In Part-II, 50 additional patients were randomized in D2 and D3 (n = 144; total 72 [22 + 50] patients/group). mITT analysis in D2 (n = 54) and D3 (n = 58) showed BOR of 29.63% (16/54, 95%CI: 17.45-41.81%) and 22.41% (13/58, 95%CI: 11.68-33.15%), respectively. DCR in D2 and D3 were 87.04% (47/54, 95%CI: 78.08-96.00%) and 82.76% (48/58; 95%CI: 73.04-92.48%) after 3 and 57.41% (31/54; 95%CI: 52.41-79.50%) and 50.00% (29/58; 95%CI: 40.40-67.00%), after 6-cycles, respectively. Hand-foot syndrome (16.67%), vomiting (9.72%) in D2, and hand-foot syndrome (18.06%), asthenia (15.28%) in D3 were most-common adverse events. CONCLUSION: FDC of capecitabine + cyclophosphamide (1800 + 80 mg/day) showed high disease control rates and good safety profile in MBC patients.

Retrospective study of oxaliplatin, leucovarin and 5 fluoruracil regimen in patients with advanced gastric cancer with poor performance status: A study at a tertiary center of South India.

BACKGROUND: Gastric carcinoma is the leading cause of cancer in south India. Gastric cancer is frequently diagnosed in locally advanced or metastatic setting in Indian scenario and has a poor survival. There is no standard chemotherapy regimen which can be used in advanced gastric cancer (AGC) patients. OBJECTIVE: The aim of this study was to assess the clinical activity and toxicity of oxaliplatin with infusional 5-fluorouracil and leucovorin administered every 3 weeks in patients with locally advanced and inoperable gastric cancer. PATIENTS AND METHODS: In this retrospective study, the case records of 25 patients who have received OLF regimen were analyzed. RESULTS: The median number of cycles for patients was 6 (range: 4-12 cycles). Overall response rate was 36%, with all patients having stable disease. Median survival of patients was 6 months (7 months in locally advanced). Compared to other regimens, there was less toxicity (less hematologic toxicity, less nausea and vomiting, no hair loss, no renal toxicity, no hand foot syndrome, and lesser admissions). CONCLUSIONS: OLF regimen is an acceptable regimen in poor performance status AGC patients with adequate response and an acceptable toxicity profile.

Desmoplastic ameloblastoma of mandible.

Desmoplastic ameloblastoma is one of the six histopathological subtypes of ameloblastoma. The age and gender groups affected by desmoplastic are similar to those affected by the conventional ameloblastoma. It usually presents as a painless enlargement of the jaw. Owing to its deceptive radiological appearance as a mixed radiopaque-radiolucent lesion, it is often mistaken as a fibro-osseous lesion. Histologically, desmoplastic ameloblastoma has a densely collagenised and hypocellular stroma, where the epithelium tends to proliferate in the form of cords and nests instead of cellular islands. Most desmoplastic ameloblastomas display occasional classic islands of follicular ameloblastoma among the predominant strands and cords. Studies have shown that desmoplastic ameloblastoma shows a tendency to recur. We present a rare case of a tumour occurring in the anterior mandibular region in a 60-year-old man over a period of 11/2 months.

Role of hemoglobin and serum iron in oral submucous fibrosis: a clinical study.

BACKGROUND: Oral submucous fibrosis is a chronic, insidious oral mucosal condition affecting the most parts of the oral cavity with high malignant transformation rate triggered by areca nut chewing, nutritional deficiencies, immunologic processes, and genetic predisposition. OSF causes significant hematological abnormalities resulting in anemia and a decrease in serum iron levels. AIM: The aim of this study was to estimate the hemoglobin and serum iron levels among patients with oral submucous fibrosis and to compare the values with healthy subjects. MATERIALS AND METHODS: In this hospital-based study 30 diagnosed patients of OSMF and 15 healthy individuals were included, and the values of hemoglobin and serum iron levels were estimated using Sahli's and Ferrene methods. RESULTS: OSMF patients showed significantly lower levels of hemoglobin and serum iron when compared with the healthy subjects. CONCLUSION: The findings of the study emphasizes on the assessment of hemoglobin and serum iron for patients with oral submucous fibrosis. Also iron therapy should be instituted concomitantly with the initial diagnosis which helps to cease the further progression of the condition. Further extensive studies are indicated to understand the correlation between OSMF and iron deficiency.