scholarly journals Clinical Study Population Subgroup

2020 ◽  
Author(s):  
Keyword(s):  
Clinical Study ◽  
Population Subgroup ◽  
Study Population

scholarly journals Erythromelalgia? A Clinical Study of People Who Experience Red, Hot, Painful Feet in the Community

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
D. Friberg ◽  
T. Chen ◽  
G. Tarr ◽  
A. van Rij
Keyword(s):  
Quality Of Life ◽  
New Zealand ◽  
Clinical Study ◽  
Clinical Symptoms ◽  
Medical Profession ◽  
Medical Attention ◽  
Study Population ◽  
Seeking Help ◽  
Moderate Effect

We recruited a population of people who clinically suffer from the symptoms of erythromelalgia, red, hot, painful feet made worse by heat and improved by cooling, to better characterise this population and measure their quality of life (QOL). Ninety-two individuals completed the QOL surveys, and 56 individuals were clinically assessed. There was a 3 : 1 ratio of females to males with an average age of 61 years. The estimated prevalence of people who had clinical symptoms of erythromelalgia in the Dunedin community was 15/100,000. Only 27% of people had received a diagnosis for their symptoms despite seeking medical attention. People in the study population had worse quality of life than the general New Zealand population(P<0.001). In the majority of participants symptoms had a mild-moderate effect on their quality of life. The results of this study indicate that the number of people who have clinical symptoms of erythromelalgia is much greater than is commonly accepted and that the majority of these individuals go unrecognised by the medical profession despite seeking help. They have significantly diminished QOL with the majority of people having mild-to-moderate symptoms.

scholarly journals The Relationship of Behavior Factors with Helminthiasis Incident on Helminthiasis Infection Disease in Pregnant Mothers in Langkat Regency

2020 ◽  
Vol 2 (1) ◽  
pp. 327-342
Author(s):  
Rini Aswita ◽  
Fazidah Aguslina Siregar ◽  
Nurmaini
Keyword(s):  
Clinical Study ◽  
Pregnant Women ◽  
Sample Size ◽  
Common Type ◽  
Behavioral Factors ◽  
Study Population ◽  
Infection Disease ◽  
Relationship Of ◽  
The Relationship ◽  
Pregnant Mothers

The aim of the study is to find out the behavior factors helminthiasis Infection Disease in Pregnant Mothers. The sample size in this study was determined based on the sample size formula for testing the hypothesis of the proportion of one clinical study population of Skovland and Vatn (2007). The results of research on the influence of behavioral factors and environmental factors on helminthiasis in pregnant women in Langkat Regency in 2019 are Helminthiasis status. There are 175 pregnant women, 20 percent of pregnant women are infected with helminthiasis, and the most common type of worm is Ascaris lumbricoides. Behavioral factors. Behavioral factors have a significant influence on the incidence of helminthiasis in pregnant women, namely the habit of wearing footwear, the habit of washing hands with soap before eating and after defecation, the habit of consuming raw food and the habit of defecating in addition to toilet.

An analysis of deficiencies identified during investigational new drug (IND) application reviews by the Division of Drug Oncology Products (DDOP) of the US FDA

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6052-6052
Author(s):  
B. S. Mann ◽  
R. Kane ◽  
M. Brave ◽  
Q. Ryan ◽  
M. Hazarika ◽  
...  
Keyword(s):  
Clinical Study ◽  
Study Protocol ◽  
Drug Dose ◽  
Stopping Criteria ◽  
Study Results ◽  
The Us ◽  
Clinical Hold ◽  
Dose Study ◽  
Study Population ◽  
Us Fda

6052 Background: Regulations require IND application review by the FDA prior to initiation of the clinical study. Deficiencies identified in the study protocol require communication between the FDA reviewers and the Sponsor for resolution. If the deficiencies are not adequately resolved, clinical hold and subsequent delay in the start of the clinical study results. To identify and analyze the commonly encountered IND application deficiencies, data from recent reviews were collected. Methods: Eight clinical reviewers analyzed the deficiencies that had been identified in 268 IND applications reviewed in the DDOP FDA from January 2003 to June 2005. All of the study protocol deficiencies leading to a clinical hold, or requiring resolution prior to study initiation were categorized as deficiencies pertaining to: patient eligibility; starting drug dose; study conduct (toxicity management, dose adjustment, stopping criteria); statistical or endpoints; non-clinical; and other issues. Results: 268 IND applications reviewed over a 30-month period by eight medical officers were analyzed. One hundred and twelve (42%) of the applications had no deficiencies; however, 156 (58%) had one (31%) or multiple (69%) deficiencies. Deficiencies pertained to study conduct/scheme (65%), dose (48%), patient eligibility (46%), others (31%), statistics or endpoints (15%), and non-clinical (4%) issues. In 141 (90%) of the deficient applications the deficiencies were adequately addressed by FDA reviewer-Sponsor communication and the trials could start as scheduled. Fifteen (10%) deficient trials were placed on clinical hold. Fourteen (93%) of these trials had multiple deficiencies that pertained to patient eligibility in 12 (80%), starting drug dose in 12 (80%), study conduct in 11 (73%), other in 7 (47%), and non-clinical and statistical issues in 2 (13%) each. Conclusions: Deficiencies were identified in 58% of the reviewed IND applications: 90% of these were resolved by FDA-Sponsor communication. Only 10% of deficient studies were placed on clinical hold; all except one had multiple deficiencies. The most common deficiencies leading to clinical hold pertained to eligibility of study population and proposed starting drug dose. No significant financial relationships to disclose.

scholarly journals Incidence of Salivary gland stone as a main cause of sialoadenitis a clinical study was done on a sample of 22 Iraqi patients

2019 ◽  
Vol 41 (2) ◽  
pp. 11-14
Keyword(s):  
Salivary Gland ◽  
Clinical Study ◽  
Surgical Techniques ◽  
Diagnostic Tools ◽  
City Hospital ◽  
Salivary Calculi ◽  
Major Teaching ◽  
Medical City ◽  
Study Population ◽  
Age Range

Background: sialolithiasis remains an entity carrying a significant morbidity. This study covers the current principles guiding the surgical management of sialolithiasis in Iraqi sample including diagnostic tools, interventional options, surgical techniques and their outcomes. Materials and Methods: A clinical study of 22 cases with salivary gland stones were collected from two major teaching and referral hospital in Baghdad “Medical city, hospital of surgical specialities” and “Al-Kinidy hospital, maxillofacial department” from 2010-2015 Results: The study population composed of 22 cases. The age range was from 10-70 year with average of 40 years. The females were 7 cases (31.81%) and males were15 (68.18%). The majority of cases were submandibular gland 16 cases (72.72%) followed by sublingual gland 5 cases (22.72%) and the parotid gland (4.54%). The presence of stone was similar on both sides. The surgical approach was applied by removal of stone in 11 cases and removal of gland in 11 cases. Conclusion: Salivary calculi are common cause of salivary gland disorder. Sialography is an important tool for assessment of salivary gland obstruction in patients presenting with It should be done after the acute symptoms are subsided. Success is measured by treatment that is efficient, clinically effective and glad sparing.

Sign in / Sign up

Export Citation Format

Share Document