A comparative evaluation: Oral leukoplakia surgical management using diode laser, CO2 laser, and cryosurgery.

Background: The comparatively evaluate the three surgical treatment modalities namely cryosurgery, diode and CO2 laser surgery in terms of healing outcomes on the day of surgery, first and second week post operatively and recurrence at the end of 18 months was assessed.

Material And Methods: Thirty selected patients were divided randomly into three groups. Each group comprising of ten patients were subjected to one of the three modalities of treatment namely cryosurgery, diode laser or CO2 laser surgery for ablation of OL.

Baseline and new-onset morphologic ECG abnormalities in healthy volunteers in phase I studies receiving placebo: changes over a 6-week follow-up period.

Morphological ECG abnormalities occur in 5-12% healthy adults participating in early phase clinical trials. We retrospectively analyzed 16,472 12-lead ECGs recorded at multiple time points in 420 volunteers (282 males, 138 females; aged 18-76 years) randomized to receive placebo from 19 Phase I studies to see if some baseline ECG abnormalities may disappear or new abnormalities may appear during the study. One hundred forty-four (34.

Comparison of two methods of estimating reader variability in QT interval measurements in thorough QT/QTc studies.

Background: Two methods of estimating reader variability (RV) in QT measurements between 12 readers were compared.

Methods: Using data from 500 electrocardiograms (ECGs) analyzed twice by 12 readers, we bootstrapped 1000 datasets each for both methods. In grouped analysis design (GAD), the same 40 ECGs were read twice by all readers.

Reader variability in QT measurement due to measurement error and variability in leads selection: a simulation study comparing 2-way vs. 3-way interaction ANOVA model.

Reader variability (RV) results from measurement differences or variability in lead used for QT measurements; the latter is not reflected in conventional methods for estimating RV. Mean and SD of QT intervals in 12 leads of 100 ECGs measured twice were used to simulate data sets with inter-RV of 5, 10, 15, 20, and 25 ms and intra-RV of 3, 6, 9, 12, and 15 ms. Six hundred twenty-five data sets were simulated such that different leads were used in Read1 and Read2 in 0, 10%, 20%, 30%, 40% of ECGs by 25 readers.

Choice of an alternative lead for QT interval measurement in serial ECGs when Lead II is not suitable for analysis.

Introduction: Conventionally, QT interval is measured in lead II. There are no data to select an alternative lead for QT measurement when it cannot be measured in Lead II for any reason.

Methods And Results: We retrospectively analyzed ECGs from 1906 healthy volunteers from 41 phase I studies.

Morphological abnormalities in baseline ECGs in healthy normal volunteers participating in phase I studies.

Background & Objectives: Morphological abnormalities in 12-lead electrocardiograms (ECGs) are seen in subgroups of healthy individuals like athletes and air-force personnel. As these populations may not truly represent healthy individuals, we assessed morphological abnormalities in ECG in healthy volunteers participating in phase I studies, who are screened to exclude associated conditions.

Methods: ECGs from 62 phase I studies analyzed in a central ECG laboratory were pooled.

QTc interval and its variability in patients with schizophrenia and healthy subjects: implications for a thorough QT study.

We compared heart rate-corrected QT interval (QTc) and its within- and between-subject variability, in ECGs recorded several days apart for 207 patients with schizophrenia (age range 19-60 yr) with age- and gender-matched healthy controls. Patients had higher heart rates (mean±s.d.

Comparison of 5 methods of QT interval measurements on electrocardiograms from a thorough QT/QTc study: effect on assay sensitivity and categorical outliers.

Introduction: We studied moxifloxacin-induced QT prolongation and proportion of categorical QTc outliers when 5 methods of QT measurement were used to analyze electrocardiograms (ECGs) from a thorough QT study.

Methods: QT interval was measured by the threshold, tangent, superimposed median beat, automated global median beat, and longest QT methods in a central ECG laboratory in 2730 digital ECGs from 39 subjects during placebo and moxifloxacin treatment.

Results: All 5 methods were able to demonstrate statistically significant moxifloxacin-induced QTcF prolongation.

Limb lead interchange in thorough QT/QTc studies.

The investigators analyzed 85,133 electrocardiograms (ECGs) recorded in 484 subjects from 5 thorough QT/QTc studies (3 using Holter devices, 2 using 12-lead ECGs) for inadvertent limb lead interchanges using a dedicated quality control process in a central ECG laboratory. Limb lead interchanges were present in 2919 (3.4%) ECGs in 17.

Effect of number of replicate electrocardiograms recorded at each time point in a thorough QT study on sample size and study cost.

In a "thorough QT/QTc" (TQT) study, several replicate electrocardiograms (ECGs) are recorded at each time point to reduce within-subject variability. This decreases the sample size but increases the cost of ECG analysis. To determine the most cost-effective number of ECG replicates, the authors retrospectively analyzed data from the placebo and moxifloxacin arms of a TQT study with crossover design.

Intra- and interreader variability in QT interval measurement by tangent and threshold methods in a central electrocardiogram laboratory.

Background: The QT interval can be measured by tangent (QT(Tan)) and threshold (QT(Thr)) methods; the better method is the one with lower reader variability.

Methods: QT(Tan) and QT(Thr) were measured twice in 100 digital electrocardiograms (ECGs) by 8 experienced readers in a central laboratory. For QT(Thr), the end of the T wave was the point where the T wave reached the isoelectric baseline; for QT(Tan), it was the point where a line from the peak of the T wave through the steepest part of the descending limb intercepted the isoelectric baseline.

Use of ANOVA to estimate inter- and intra-reader variability for a group of readers in thorough QT/QTc studies.

The E14 guidelines of the International Conference on Harmonization require that all new drugs that have systemic bioavailability be subjected to a thorough QT/QTc study to look for possible effects on cardiac repolarization. Recent publications have discussed various aspects of thorough QTc studies. The thorough QTc study is designed to detect a mean drug-induced QTc prolongation of >5 ms with an upper bound of the 95% one-sided confidence limits of >10 ms.

Trends in cancers of the upper alimentary and respiratory tracts in women in bombay, India.

Cancers of the upper alimentary and respiratory tracts are proven to be causally associated with tobacco use and are therefore preventable. These cancers form 50% of all cancers in men and 20% in women in Bombay. This study reports on the trends in women for these cancers (observed in the Bombay Cancer Registry during 1964-81) which were found to be by and large similar to those reported elsewhere for males.

Cancer incidence in Indian Christians.

Differences in habits, customs and ethnic characteristics have provided important leads for the study of cancer in Indian Christians. It is a sign of the times that some of the social customs rigidly upheld by the older generations are rapidly giving way to "Modernism". An attempt has been made to examine the differences found in the site-specific cancer risks in this community in Bombay.

Cancer in Indian Moslems.

Moslems are the followers of Islam who, during the time of the Ghaznavid dynasty of Afghanistan, invaded India for the first time. Islam attaches equal importance to material and spiritual aspects of human life. Men and women have equal cultural rights.

Histological and epidemiological features of breast cancer in different religious groups in greater Bombay.

In this paper an attempt has been made to study the histologic and epidemiologic features of breast cancer in women from various religious groups of Greater Bombay. The crude and age-adjusted incidence rates are seen to be the highest in the Parsi community followed by the Christian, Moslem, and Hindu groups. In all the religious groups, an increase in incidence of breast cancer is first seen in the third decade.

Cancer in the Sindhi population of Greater Bombay.

The Sindhis are a Hindu subgroup identified by their place of origin and their written spoken language. These are the people who were originally inhabitants of the Province of Sind, which formed a part of the large Bombay Presidency in Undivided India before 1947. The Sindhi Hindus migrated en masse to India after partition.

Differences observed in the site incidence of cancer, between the Parsi community and the total population of greater Bombay: a critical appraisal.

The Bombay Cancer Registry has been in operation since June 1963 and reliable morbidity data on cancer have since been obtained for the first time in India, from a precisely outlined population base delineated by residential qualifications within strict geographicalboundaries. An attempt has been made to examine the differences noticed in the site-specific cancer risks, between 2 groups of people living in this area-the Parsi community and the total Bombay population. The over-all age adjusted rates for the Parsis were found to be lower than those for the total population and more noticeably, their site-specific risks seem to differ radically from the Greater Bombay pattern.