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Study Protocol (study + protocol)
Selected AbstractsTrials update in walesCYTOPATHOLOGY, Issue 2007A. Fiander Three ongoing studies will be presented and discussed. Prevalence of Human Papillomavirus Infection in a South Wales Screening population Methods: A total of 10 000 consecutive, anonymous liquid based cytology screening samples were collected over a five month period in 2004. Age, cytology result and social deprivation score was provided for each specimen. The methodology was chosen to ensure inclusion of all women attending routine cervical screening, avoiding potential constraints associated with obtaining individual informed consent. The liquid based cytology samples were processed and reported by the receiving cytology laboratory and the residual specimens sent to the HPV Research Laboratory, Wales College of Medicine, where they were processed and stored at -80°C until analysis. High risk and low risk HPV Typing was undertaken using PCR , EIA (Jacobs et al 1997). Full high risk typing was performed on HPV positive specimens. Results: The study population had a mean age of 38 years with 92% negative, 5% borderline and 3% dyskaryotic cytology. The average social deprivation score was 17.4 (based upon the Welsh Index of multiple deprivation). The following results will be presented: HPV prevalence by age. HPV prevalence by cytology result. Type specific HPV prevalence in single and multiple infection. Conclusion: This study represents the largest type specific HPV Prevalence Study in the UK to date. As such it will form a useful base line against which to access performance of marketed HPV tests and evaluating the impact following implementation of HPV vaccination. [Funded by Welsh Office for Research and Development] CRISP , 1 Study (Cervical Randomized Intervention Study Protocol -1) Background: Indole-3-carbinol (I3C) and Diindolylmethane (DIM) are found in cruciferous vegetables and have been identified as compounds that could potentially prevent or halt carcinogenesis. I3C spontaneously forms DIM in vivo during acid digestion. I3C has been shown to prevent the development of cervical cancer in HPV 16 transgenic mice and both I3C and DIM have been shown to promote cell death in cervical cancer cell models. DIM is the major active bi-product of I3C and preliminary data indicate that DIM is active in cervical dysplasia and may be better tolerated than I3C. Aim: To investigate chemoprevention of high grade cervical neoplasia using Diindolylmethane (DIM) supplementation in women with low grade cytological abnormalities on cervical cytology. Objectives: To observe any reduction in the prevalence of histological proven high-grade cervical intraepithelial neoplasia (CIN) after 6 months of supplementation. ,,To observe any reduction in the prevalence of cytological abnormalities. ,,To observe any changes in the clinical appearance of the cervix. To assess acceptability and monitor any side effects of DIM supplementation. ,,To assess whether any benefit is seen in relation to Human Papillomavirus (HPV) status including HPV Type, Viral load and integration. Methods: This is a double blind randomized placebo-controlled trial involving 600,700 women with low grade cytological abnormalities on a cervical smear. Randomization is in the ratio of 2 : 1 in favour of active medication. Women with first mildly dyskaryotic smear or second borderline smear are eligible. They are asked to take two capsules daily for 6 months. At the end of 6 months they undergo repeat cervical cytology, HPV testing and colposcopy. Results: A progress report will be given for this ongoing study. [Funded: - Cancer Research UK] Type Specific HPV Infection in Welsh Cervical Cancers Background: Whilst there have been numerous studies of HPV infection associated with cervical cancer and on prevalence of Human Papillomavirus in diverse populations there have been no studies of these variables in the same population. Against a background of prophylactic HPV vaccination it is important to assess potential protection against cervical cancer within a given population. The most comprehensive analysis of HPV type specific cervical cancer is a meta-analysis published by the IARC in 2003. This however included only three UK based studies, totalling 118 cases, 75 of which were only investigated by HPV type PCR for four high risk types. None of this data was presented with associated population based prevalence data. Therefore, the research objectives for this study in combination with the first study above, are as follows: To determine the frequency of specific HPV types in cervical cancers in Wales. To compare the distribution of specific HPV types amongst cervical cancers with their prevalence in the general population. This will allow accurate delineation of the relationship between prevalence of specific HPV types in the general population and their association with clinically relevant disease. This information is a pre-requisite to assess the potential impact of prophylactic vaccination against HPV infection in Wales. Methods: Welsh Cervical Cancer specimens from 2000,2005 will be identified from pathology departments within Wales. The pathology of each tumour will be reviewed by a single Gynaecological Pathologist. The age of the patient and pathological features of the tumour will be noted. DNA will be extracted from the paraffin sections and HPV typed by PCR-EIA. Results: A progress report will be given for this ongoing study. [Funded by Welsh Office for Research and Development] [source] Preserving Normal Ventricular Activation Versus Atrioventricular Delay Optimization During Pacing: The Role of Intrinsic Atrioventricular Conduction and Pacing RatePACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1 2000IVAN ILIEV ILIEV The purpose of the study was to compare the effects of DDD pacing with optimal AV delay and AAI pacing on the systolic and diastolic performance at rest in patients with prolonged intrinsic AV conduction (first-degree AV block). We studied 17 patients (8 men, aged 69 ± 9 years) with dual chamber pacemakers implanted for sick sinus syndrome in 15 patients and paroxysmal high degree AV block in 2 patients. Aortic flow and mitral flow were evaluated using Doppler echocardiography. Study protocol included the determination of the optimal A V delay in the DDD mode and comparison between AAI and DDD with optimal A V delay for pacing rate 70/min and 90/min. Stimulus-R interval during AAI (AHI) was 282 ± 68 ms for rate 70/min and 330 ± 98 ms for rate 90/min (P < 0.01). The optimal A V delay was 159 ± 22 ms, A V delay optimization resulted in an increase of an aortic flow time velocity integral (AFTVI) of 16%± 9%. At rate 70/min the patients with ARI , 270 ms had higher AFTVI in AAI than in DDD (0.214 ± 0.05 m vs 0.196 ± 0.05 m, P < 0.01), while the patients with ARI > 270 ms demonstrated greater AFTVI under DDD compared to AAI(0.192 ± 0.03 m vs 0.166 ± 0.02 m, P < 0.01). At rate 90/min AFTVI was higher during DDD than AAI (0.183 ± 0.03 m vs 0.162 ± 0.03 m, P < 0.01). Mitral flow time velocity integral (MFTVI) at rate 70/min was higher in DDD than in AAI (0.189 ± 0.05 m vs 0.173 ± 0.05 mP < 0.01), while at rate 90/min the difference was not significant in favor of DDD (0.149 ± 0.05 m vs 0.158 ± 0.04 m). The results suggest that in patients with first-degree AV block the relative impact of DDD and AAI pacing modes on the systolic performance depends on the intrinsic AV conduction time and on pacing rate. [source] KERNEL DENSITY ESTIMATION WITH MISSING DATA AND AUXILIARY VARIABLESAUSTRALIAN & NEW ZEALAND JOURNAL OF STATISTICS, Issue 3 2009Suzanne R. Dubnicka Summary In most parametric statistical analyses, knowledge of the distribution of the response variable, or of the errors, is important. As this distribution is not typically known with certainty, one might initially construct a histogram or estimate the density of the variable of interest to gain insight regarding the distribution and its characteristics. However, when the response variable is incomplete, a histogram will only provide a representation of the distribution of the observed data. In the AIDS Clinical Trial Study protocol 175, interest lies in the difference in CD4 counts from baseline to final follow-up, but CD4 counts collected at final follow-up were incomplete. A method is therefore proposed for estimating the density of an incomplete response variable when auxiliary data are available. The proposed estimator is based on the Horvitz,Thompson estimator, and the propensity scores are estimated nonparametrically. Simulation studies indicate that the proposed estimator performs well. [source] Is there a SSRI dose response in treating major depression?DEPRESSION AND ANXIETY, Issue 1 2003The case for re-analysis of current data, for enhancing future study design Abstract It has been widely stated that the available research data has not demonstrated a SSRI dose response for major depression. We re-evaluated the methods used to analyze the SSRI data by clarifying two key alternative definitions of dose response and their implications for enhancing analysis of currently available data as well as future study design. We differentiated "potential" dose response, which focuses exclusively on response excluding tolerability effects and asks whether differences in dose can result in significant differences in response, from "expressed" dose response, which incorporates all tolerability effects currently associated with dose (including those caused by study protocol or treatment practice) and asks whether differences in dose do result in significant differences in response. To analyze potential dose response for all studies, one should use a "dose-tolerant" sample, i.e., an ITT sample from which dropouts due to adverse events have been removed. To analyze an expressed dose response, an ITT sample is the optimum sample if the study conforms to several design specifications. In the absence of conformance to these specifications, an ITT sample may be an approximation of the appropriate sample. Given design limitations of currently available studies, a dose-tolerant sample may provide a more informative approximation of an optimal sample to be used in evaluating the expressed dose response that could be expected in the best clinical practice. Future studies of dose-response relations could be enhanced by taking into account the principles noted above, and currently available data should be reanalyzed based on these principles. This re-analysis is performed in a companion article [Baker et al. 2003, Depress Anxiety 17:1-9]. Depression and Anxiety 17:10,18, 2003. © 2003 Wiley-Liss, Inc. [source] ,Rescue' Therapy with Rifabutin after Multiple Helicobacter pylori Treatment FailuresHELICOBACTER, Issue 2 2003Javier P. Gisbert abstract Aim. Eradication therapy with proton pump inhibitor, clarithromycin and amoxicillin is extensively used, although it fails in a considerable number of cases. A ,rescue' therapy with a quadruple combination of omeprazole, bismuth, tetracycline and metronidazole (or ranitidine bismuth citrate with these same antibiotics) has been recommended, but it still fails in approximately 20% of cases. Our aim was to evaluate the efficacy and tolerability of a rifabutin-based regimen in patients with two consecutive H. pylori eradication failures. Patients and Methods. Design: Prospective multicenter study. Patients: Consecutive patients in whom a first eradication trial with omeprazole, clarithromycin and amoxicillin and a second trial with omeprazole, bismuth, tetracycline and metronidazole (three patients) or ranitidine bismuth citrate with these same antibiotics (11 patients) had failed were included. Intervention: A third eradication regimen with rifabutin (150 mg bid), amoxicillin (1 g bid) and omeprazole (20 mg bid) was prescribed for 14 days. All drugs were administered together after breakfast and dinner. Compliance with therapy was determined from the interrogatory and the recovery of empty envelopes of medications. Outcome: H. pylori eradication was defined as a negative 13C-urea breath test 8 weeks after completing therapy. Results. Fourteen patients have been included. Mean age ± SD was 42 ± 11 years, 41% males, peptic ulcer (57%), functional dyspepsia (43%). All patients took all the medications and completed the study protocol. Per-protocol and intention-to-treat eradication was achieved in 11/14 patients (79%; 95% confidence interval = 49,95%). Adverse effects were reported in five patients (36%), and included: abdominal pain (three patients), nausea and vomiting (one patient), and oral candidiasis (one patient); no patient abandoned the treatment due to adverse effects. Conclusion. Rifabutin-based rescue therapy constitutes an encouraging strategy after multiple previous eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole and tetracycline. [source] Benzodiazepine use in the elderly: an indicator for inappropriately treated geriatric depression?INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 6 2009Eva Assem-Hilger Abstract Objective To measure the prevalence of benzodiazepine (BZD) use and to explore associated demographic and clinical variables of BZD use within a cohort of 75-year- old inhabitants of an urban district of Vienna. Methods This is a prospective, interdisciplinary cohort study on aging. Our investigation is based on the first consecutive 500 subjects that completed the study protocol. Demographic and clinical characteristics, benzodiazepine and antidepressant use were documented using a standardized questionnaire. Affective status was assessed using the Hamilton Depression Rating Scale (HAMD), the Geriatric Depression Scale (GDS), and the Spielberger State-and Trait Anxiety Inventory subscales (STAI). Results Prevalence of BZD use was 13.8%. Compared to non-users, BZD users had significantly higher mean scores at the HAMD (p,=,0.001), the GDS (p,=,0.026), and the Spielberger State-and Trait Anxiety Inventory subscales (p,=,0.003; p,=,0.001). Depression was found in 12.0% (HAMD) and 17.8% when using a self-rating instrument (GDS). Less than one-third of depressed subjects were receiving antidepressants. Statistically equal numbers were using benzodiazepines. Conclusions Inappropriate prescription of BZD is frequent in old age, probably indicating untreated depression in many cases. The implications of maltreated geriatric depression and the risks associated with benzodiazepine use highlight the medical and socioeconomic consequences of inappropriate BZD prescription. Copyright © 2008 John Wiley & Sons, Ltd. [source] Effect of xylitol and xylitol,fluoride lozenges on approximal caries development in high-caries-risk childrenINTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 3 2008CHRISTINA STECKSÉN-BLICKS Aim., To evaluate the effect of xylitol- and xylitol/fluoride-containing lozenges on approximal caries development in young adolescents with high caries risk. Study design., A 2-year double-blind trial with two parallel arms and a nonrandomized reference group. Material and methods., One hundred and sixty healthy 10- to 12-year-old children with high caries risk were selected. After informed consent, they were randomly assigned into a xylitol and a xylitol/fluoride group. They were instructed to take two tablets three times a day (total xylitol and fluoride dose 2.5 g and 1.5 mg, respectively). The compliance was checked continuously and scored as good, fair, or poor. A reference no-tablet group was also selected (n = 70) for group comparison. The outcome measure was approximal caries incidence. Results., The dropout rate was 28%, and 41% exhibited a good compliance with the study protocol. No statistically significant differences in caries incidence could be found between the study groups (P > 0.05). Among a subgroup of children who demonstrated good compliance, the mean ,DMFSa value was significantly lower in the xylitol/fluoride group compared to the xylitol group, 1.0 ± 2.3 vs. 3.3 ± 4.6 (P < 0.05), while no difference could be displayed between any of the study groups and the reference group (P > 0.05). Conclusion., The results from this 2-year trial did not support a self-administered regimen of xylitol- or xylitol/fluoride-containing lozenges for the prevention of approximal caries in young adolescents with high caries risk. [source] A bladder preservation regimen using intra-arterial chemotherapy and radiotherapy for invasive bladder cancer: A prospective studyINTERNATIONAL JOURNAL OF UROLOGY, Issue 2 2000Naoto Miyanaga Abstract Background: A prospective study was performed to investigate combined treatment with intra-arterial chemotherapy and radiation therapy for bladder preservation in locally invasive bladder cancer. Methods: Patients with invasive bladder cancer, stage T2,3N0M0, were included in the study. Intra-arterial chemotherapy was performed with three injections of methotrexate and cisplatin at 3-week intervals. Simultaneously, the patients underwent X-ray irradiation (40 Gy) of the small pelvic space. Where a post-treatment transurethral resection (TUR) biopsy showed no residual tumor, the tumor site was irradiated by a 30 Gy proton beam and the bladder was preserved. Where tumors remained, radical cystectomy was performed. Results: Between 1990 and 1996, 42 patients were treated according to this protocol. Post-treatment TUR biopsy and urine cytology showed no residual tumors in 39 of 42 cases (93%). The bladder was preserved in accordance with the study protocol in 36 cases. A median follow-up of 38 months showed 3-year non-recurrence in 72% of bladder-preserved patients and the rate of bladder preservation was 84%. The nine recurrences included eight cases of superficial bladder recurrence. One cancer death occurred among the bladder-preservation patients, giving 3-year survival and cause-specific survival rates of 84% and 100%, respectively. Although bladder function decreased slightly in compliance, bladder capacity was retained in almost all cases. Conclusions: This regimen is useful for bladder preservation in T2,3 locally invasive bladder cancer. Information from more cases and the results of more long-term observations are needed, as is an evaluation of appropriate subject selection and factors associated with quality of life issues, particularly regarding bladder function. [source] Realistic Evaluation of Early Warning Systems and the Acute Life-threatening Events , Recognition and Treatment training course for early recognition and management of deteriorating ward-based patients: research protocolJOURNAL OF ADVANCED NURSING, Issue 4 2010Jennifer McGaughey mcgaughey j., blackwood b., o'halloran p., trinder t.j. & porter s. (2010) Realistic Evaluation of Early Warning Systems and the Acute Life-threatening Events , Recognition and Treatment training course for early recognition and management of deteriorating ward-based patients: research protocol. Journal of Advanced Nursing66(4), 923,932. Abstract Title.,Realistic Evaluation of Early Warning Systems and the Acute Life-threatening Events , Recognition and Treatment training course for early recognition and management of deteriorating ward-based patients: research protocol. Aim., This paper is a description of a study protocol designed to evaluate the factors that enable or constrain the delivery and sustainability of Early Warning Systems and the Acute Life-threatening Events , Recognition and Treatment training course in practice. Background., Rapid response system initiatives have been introduced to try to improve early detection and treatment of patients who deteriorate on general hospital wards. However, recent systematic reviews of the effectiveness of these initiatives show no effect on patient outcomes. Systematic reviews and professional consensus recommend that future research should focus on a broader range of process and outcome measures which consider the social, behavioural and organizational factors that had an impact on the delivery of these initiatives. Design., The design is a multiple case study on four wards in two hospitals in Northern Ireland that have implemented Early Warning Systems and Acute Life-threatening Events , Recognition and Treatment training. Data will be collected from key stakeholders using individual and focus group interviews, non-participant observation, Acute Life-threatening Events , Recognition and Treatment training records and audit of patients' observation charts and medical notes. Realistic Evaluation of the data will enable the development and refinement of theories to explain which mechanisms work in a particular context to achieve desired outcomes. Discussion., This study will produce important information that will contribute to knowledge of the organizational processes that have an impact on the delivery of initiatives to identify, respond and manage acutely ill patients in hospital. [source] Parent's involvement in decisions when their child is admitted to hospital with suspected shunt malfunction: study protocolJOURNAL OF ADVANCED NURSING, Issue 10 2009Joanna Smith Abstract Title., Parent's involvement in decisions when their child is admitted to hospital with suspected shunt malfunction: study protocol. Aim., This paper outlines the protocol for a study aimed at exploring parent's involvement during professional,parent interactions and decisions about their child's care in the context of suspected shunt malfunction. Background., Hydrocephalus is a long-term condition treated primarily by the insertion of a shunt that diverts fluid from the brain to another body compartment. Shunts frequently malfunction, and parents of children with shunted hydrocephalus are responsible for recognizing and responding to shunt complications. Parents feel that interactions with professionals when they seek healthcare advice for their child do always not encourage active participation in care decisions. Methods., The study design is based on qualitative methodologies: a combination of conversation analysis applied to consultation recordings of professional,parent interactions when a child is admitted to hospital with suspected shunt malfunction, and semi-structured follow-up interviews with the same participants within 2 weeks of the consultation. Participants., This is a prospective study and participants will be purposefully selected. Parents of children who have been admitted to hospital with suspected shunt malfunction and healthcare professionals responsible for the initial assessment of the child will be invited to participate. Discussion., The study will identify how decisions about a child's care are negotiated between parents and healthcare professionals at key stages of the care pathway. In addition, examining interactions between healthcare professionals and parents may identify approaches that support or hinder parents in contributing to the decision-making processes when they seek advice from healthcare professionals. [source] Lifestyle limitations of children and young people with severe cerebral palsy: a population study protocolJOURNAL OF ADVANCED NURSING, Issue 5 2008Collette Donnelly Abstract Title.,Lifestyle limitations of children and young people with severe cerebral palsy: a population study protocol Aim., This paper is a presentation of a study protocol to establish the prevalence of orthopaedic problems (hip dislocation, pelvic obliquity, spinal deformity and contractures) and their impact on pain, function, participation and health in a population of children and young people with severe cerebral palsy. Background., Cerebral palsy is the commonest cause of motor impairment in childhood and is associated with life-long disability. An estimated 30% of people with cerebral palsy have severe forms and are non-ambulant. Although the underlying neurological damage is not amenable to correction, many health services are dedicated to providing therapeutic and adaptive support to help people with the condition reach their potential. Method., A cross-sectional survey of children and young people, aged 4,25 years with severe, non-ambulant cerebral palsy as defined using the Gross Motor Function Classification System (Levels IV and V). Study participants will be identified from a pre-existing, geographically defined case register and recruited via a healthcare professional known to them. Two assessments will be undertaken: one involving parents/carers at home and using questionnaires; the other involving the child/young person ideally in one of three settings and including X-rays if clinically indicated. Discussion., This study will contribute to our knowledge of the history and epidemiology of orthopaedic problems in children and young people with cerebral palsy and how these problems accumulate and impact on participation, health and well-being. The study will also identify unmet need and make recommendations for good practice in relation to the orthopaedic care and management for people with severe cerebral palsy. [source] High intrathecal bupivacaine for severe pain in the head and neckACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 7 2009C. LUNDBORG Background: Severe pain in the head and neck is associated with a lowered quality of life and conventional pain therapy often does not provide adequate relief. The aims of this study were to investigate the efficacy, pain relief, benefits and adverse effects of intracisternal or high cervical (IHC) administration of bupivacaine in patients with severe pain in the head, neck and face regions. Methods: Between 1990 and 2005, 40 patients (age 27,84 years) were treated with continuous IHC infusions of bupivacaine for various non-cancer (n=15) or cancer-related (n=25) refractory pain conditions (duration 1 month,18 years) in the head, neck, mouth and shoulder regions. Results: Visual analogue scale scores and opioid requirements decreased markedly after the start of the treatment and remained lowered throughout the study. No tachyphylaxis for bupivacaine was observed. Major side effects were few and most often transient. Most patients showed unchanged or improved mobility. There was no mortality, neurological damage or other severe events attributable to procedures in the study protocol. Conclusion: For patients with severe and refractory pain in areas innervated by cranial and upper cervical nerves, cervical high spinal analgesia can provide safe and effective analgesia. [source] Efficacy of a standardized echinacea preparation (EchinilinTM) for the treatment of the common cold: a randomized, double-blind, placebo-controlled trialJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 1 2004V. Goel PhD Summary Background:, Recently, echinacea has regained popularity as one of the treatments chosen most commonly by consumers with the expectation that it will reduce the severity and duration of the common cold. However, the results from a limited number of clinical trials for this application have thus far been inconclusive. This incongruity may be the result of investigators utilizing poorly standardized echinacea products, likely devoid of sufficient quantities of active constituents necessary to exert a definitive clinical effect. Therefore, a formulation containing alkamides, cichoric acid, and polysaccharides at concentrations of 0·25, 2·5, and 25 mg/mL, respectively, was prepared from freshly harvested Echinacea purpurea plants (commercially available as Echinilin, Natural Factors Nutritional Products, Inc., Vancouver, BC, Canada). The objective of this study was to test the efficacy of this highly standardized formulation in reducing the severity and duration of symptoms of a naturally acquired common cold. Methods:, In a randomized, double-blind, placebo-controlled trial, 282 subjects aged 18,65 years with a history of two or more colds in the previous year, but otherwise in good health, were recruited. The subjects were randomized to receive either echinacea or placebo. They were instructed to start the echinacea or placebo at the onset of the first symptom related to a cold, consuming 10 doses the first day and four doses per day on subsequent days for 7 days. Severity of symptoms (10-point scale: 0, minimum; 9, maximum) and dosing were recorded daily. A nurse examined the subjects on the mornings of days 3 and 8 of their cold. Results:, A total of 128 subjects contracted a common cold (59 echinacea, 69 placebo). The total daily symptom scores were found to be 23·1% lower in the echinacea group than in placebo in those who followed all elements of the study protocol (P < 0·01). Throughout the treatment period, the response rate to treatments was greater in the echinacea group. A few adverse event profiles were observed in both groups. Conclusions:, Early intervention with a standardized formulation of echinacea resulted in reduced symptom severity in subjects with naturally acquired upper respiratory tract infection. Further studies with larger patient populations appear to be warranted. [source] Magnetic resonance imaging for ischemic heart diseaseJOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 1 2007Hajime Sakuma MD Abstract Cardiac MRI has long been recognized as an accurate and reliable means of evaluating cardiac anatomy and ventricular function. Considerable progress has been made in the field of cardiac MRI, and cardiac MRI can provide accurate evaluation of myocardial ischemia and infarction (MI). Late gadolinium (Gd)-enhanced MRI can clearly delineate subendocardial infarction, and the assessment of transmural extent of infarction on late enhanced MRI has been shown to be useful in predicting functional recovery of dysfunctional myocardium in patients after MI. Stress first-pass contrast-enhanced (CE) myocardial perfusion MRI can be used to detect subendocardial ischemia, and recent studies have demonstrated the high diagnostic accuracy of stress myocardial perfusion MRI for detecting significant coronary artery disease (CAD). Free-breathing, whole-heart coronary MR angiography (MRA) was recently introduced as a method that can provide visualization of all three major coronary arteries within a single three-dimensional (3D) acquisition. With further improvements in MRI techniques and the establishment of a standardized study protocol, cardiac MRI will play a pivotal role in managing patients with ischemic heart disease. J. Magn. Reson. Imaging 2007;26:3,13. © 2007 Wiley-Liss, Inc. [source] Accrediting radiation technique in a multicentre trial of chemoradiation for pancreatic cancerJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 6 2008N Spry Summary Before a multicentre trial of 3-D conformal radiotherapy to treat cancer of the pancreas, participating clinicians were asked to complete an accreditation exercise. This involved planning two test cases according to the study protocol, then returning hard copies of the plans and dosimetric data for review. Any radiation technique that achieved the specified constraints was allowed. Eighteen treatment plans were assessed. Seven plans were prescribed incorrect doses and two of the planning target volumes did not comply with protocol guidelines. All plans met predefined normal tissue dose constraints. The identified errors were attributable to unforeseen ambiguities in protocol documentation. They were addressed by feedback and corresponding amendments to protocol documentation. Summary radiobiological measures including total weighted normal tissue equivalent uniform dose varied significantly between centres. This accreditation exercise successfully identified significant potential sources of protocol violations, which were then easily corrected. We believe that this process should be applied to all clinical trials involving radiotherapy. Due to the limitations of data analysis with hard-copy information only, it is recommended that complete planning datasets from treatment-planning systems be collected through a digital submission process. [source] Fetal arrhythmia: Prenatal diagnosis and perinatal managementJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 4 2009Yasuki Maeno Abstract The importance of managing fetal arrhythmia has increased over the past three decades. Although most fetal arrhythmias are benign, some types cause fetal hydrops and can lead to fetal death. With the aim of improving the outcome in such cases, various studies for prenatal diagnosis and perinatal management have been published. Detailed analysis of the type of arrhythmia in utero is possible using M-mode and Doppler echocardiography. In particular, a simultaneous record of Doppler waveform at the superior venous cava and the ascending aorta has become an important and useful method of assessing the interval between atrial and ventricular contractions. Common causes of fetal tachycardia (ventricular heart rate faster than 180 bpm), are paroxysmal supraventricular tachycardia (SVT) with 1:1 atrioventricular (AV) relation and atrial flutter with 2:1 AV relation. Of fetal SVT, short ventriculo-atrial (VA) interval tachycardia due to atrioventricular reentrant tachycardia is more common than long VA interval. Most fetuses with tachycardia are successfully treated in utero by transplacental administration of antiarrhythmic drugs. Digoxin is widely accepted as a first-line antiarrhythmic drug. Sotalol, flecainide and amiodarone are used as second-line drugs when digoxin fails to achieve conversion to sinus rhythm. Fetal bradycardia is diagnosed when the fetal ventricular heart rate is slower than 100 bpm, mainly due to AV block. Approximately half of all cases are caused by associated congenital heart disease, and the remaining cases that have normal cardiac structure are often caused by maternal SS-A antibody. The efficacy of prenatal treatment for fetal AV block is limited compared with treatment for fetal tachycardia. Beta stimulants and steroids have been reported as effective transplacental treatments for fetal AV block. Perinatal management based on prospective clinical study protocol rather than individual experience is crucial for further improvement of outcome in fetuses with tachycardia and bradycardia. [source] Transvaginal Hysterosalpingo-Contrast Sonography (HyCoSy) Compared with ChromolaparoscopyJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 1 2000Dr. Somchai Tanawattanacharoen Abstract Objective: To compare the efficacy and safety of HyCoSy with chromolaparoscopy for the diagnosis of tubal occlusion and uterine abnormalities. Methods: Sixty infertile women in whom the cause of infertility was thought to be tubal occlusion or uterine abnormalities and who satisfied the inclusion and exclusion criteria as specified in the study protocol were included. HyCoSy was performed during the first half of the menstrual cycle at least 24 hours prior to chromolaparoscopy. The results from both HyCoSy and chromolaparoscopy were compared in assessing tubal occlusion and uterine pathology. Results: For the evaluation of fallopian tubes, we found corresponding results between HyCoSy and chromolaparoscopy in 80.0%. The agreement between both procedures in assessing the uterine pathology was 80.4%. Twenty-two women experienced adverse events. The most common complaint was pelvic pain. Other events encountered were: nausea (3 women) and vaginal bleeding (2 women). All events were thought to be not related to the study drug. Conclusion: HyCoSy showed good diagnostic performance in the evaluation of the fallopian tubes and uterus in infertile women. The adverse events reported in this study are minor and procedure-related (catheter insertion) rather than the trial substance. [source] Criteria for Pacemaker Explant in Patients Without a Precise Indication for Pacemaker ImplantationPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 3 2002MARTINO MARTINELLI MARTINELLI, M., et al.: Criteria for Pacemaker Explant in Patients Without a Precise Indication for Pacemaker Implantation. Unnecessary pacemaker implantation may cause significant social and psychological consequences, the inconvenience of periodic office visits, and the expense of pulse generator replacement. Establishing adequate criteria for explanting pacemakers is crucial and has not yet been described. This study presents the results of a study protocol for explanting the pacemaker in patients without a clear indication for pacemaker implantation. Seventy pacemaker users without a clear reason for the implantation were included in the study conducted from August 1986 to November 1998 and were prospectively followed. The investigation consisted of clinical and neurological evaluations, echocardiogram, exercise testing, and tilt table testing. When these tests were negative, the pulse generator energy and stimulation rates were reprogrammed to the lowest values. Periodic Holter monitoring was conducted during follow-up. When asymptomatic for 1 year, patients underwent an electrophysiological evaluation of sinus and atrioventricular junction function and ventricular vulnerability. When the electrophysiological study was negative, pacemaker explantation was performed. Of the 70 patients, 35 had their pacemaker explanted; 3 were excluded due to a positive tilt table test and electrophysiological study, and 3 are waiting for pacemaker explantation. Mean follow-up after pacemaker explantation was 30.3 months, and all patients remained asymptomatic, except for one patient who died of a noncardiac cause. Critical analysis of pacemaker users without a well-established indication is justified because it may allow pacemaker explant in a significant proportion of these patients, and it may bring considerable social, economic, and psychological benefits. [source] Attitudes toward participation in a pregnancy and child cohort studyPAEDIATRIC & PERINATAL EPIDEMIOLOGY, Issue 3 2006Julie L. Daniels Summary While epidemiological studies aim for high participation rates, it is becoming increasingly difficult to recruit and retain participants in lengthy observational studies. We surveyed women who recently participated in the Pregnancy, Infection, and Nutrition Study during their pregnancy to learn more about what initially motivated them to participate in the study, their attitudes about the study protocol, and whether they would allow their child to participate in future studies. Most women were motivated by their interest in science and learning about their pregnancy. In general, women felt quite comfortable with most aspects of the study. Consent forms, telephone interviews and self-administered questionnaires were the most acceptable components of the study, but even specimen collection was well tolerated by this cohort. Women were less comfortable with the possibility of their child participating in future research. This survey confirmed that once women are enrolled, they tend to be willing to complete most components of an intensive study, suggesting that initial efforts for recruitment are most important. [source] Sedation with ketamine and low-dose midazolam for short-term procedures requiring pharyngeal manipulation in young childrenPEDIATRIC ANESTHESIA, Issue 1 2008HELENA NOVAK MD Summary Background:, Pediatric intestinal biopsy procedures including considerable transpharyngeal manipulation of a wire-guided metal capsule require adequate sedation or anesthesia. This retrospective cohort study was designed to evaluate intravenous sedation with ketamine and low-dose midazolam in young children undergoing these procedures before and also after discharge from the hospital. Methods:, A total of 244 biopsy procedures in 217 children under the age of 16 years were evaluated. All anesthesia records were reviewed according to a defined study protocol and in 145 cases the parents were also interviewed by telephone to obtain further information on possible adverse effects before and after discharge. Results:, Ketamine and low-dose midazolam were carefully titrated by an experienced anesthesia team at an approximate dose ratio of 40 : 1 (total doses 2.3 and 0.05 mg·kg,1) in continuously monitored spontaneously breathing children. Possibly associated problems before discharge were salivation (5.7%), vomiting (4.9%), oxygen desaturation (3.3%), laryngospasm (2.5%) and rash (1.2%) according to the patient records and blurred vision (27%), nausea and vomiting (19%), vertigo (13%) and hallucinations or nightmares (3.5%) according to telephone interviews. Few, mild and transient problems remained after discharge from the hospital. Conclusions:, Careful titration of ketamine and low-dose midazolam provides adequate sedation for nonsurgical pediatric short-term procedures also requiring considerable pharyngeal manipulation, particularly considering the low number of serious airway problems such as laryngospasm. The high incidence of late postoperative problems suggests that prospective studies should be designed for long-term follow-up of young children subjected to sedation or anesthesia. [source] Frequency of sub-clinical cerebral edema in children with diabetic ketoacidosisPEDIATRIC DIABETES, Issue 2 2006Nicole S Glaser Abstract:, Symptomatic cerebral edema occurs in approximately 1% of children with diabetic ketoacidosis (DKA). However, asymptomatic or subclinical cerebral edema is thought to occur more frequently. Some small studies have found narrowing of the cerebral ventricles indicating cerebral edema in most or all children with DKA, but other studies have not detected narrowing in ventricle size. In this study, we measured the intercaudate width of the frontal horns of the lateral ventricles using magnetic resonance imaging (MRI) in children with DKA during treatment and after recovery from the DKA episode. We determined the frequency of ventricular narrowing and compared clinical and biochemical data for children with and without ventricular narrowing. Forty-one children completed the study protocol. The lateral ventricles were significantly smaller during DKA treatment (mean width, 9.3 ± 0.3 vs. 10.2 ± 0.3 mm after recovery from DKA, p < 0.001). Children with ventricular narrowing during DKA treatment (22 children, 54%) were more likely to have mental status abnormalities than those without narrowing [12/22 vs. 4/19 with Glasgow Coma Scale (GCS) scores below 15 during therapy, p = 0.03]. Multiple logistic regression analysis revealed that a lower initial PCO2 level was significantly associated with ventricular narrowing [odds ratio (OR) = 0.88, 95% confidence interval (95% CI) = 0.78,0.99, p = 0.047). No other variables analyzed were associated with ventricular narrowing in the multivariate analysis. We conclude that narrowing of the lateral ventricles is evident in just over half of children being treated for DKA. Although children with ventricular narrowing did not exhibit neurological abnormalities sufficient for a diagnosis of ,symptomatic cerebral edema', mild mental status abnormalities occurred frequently, suggesting that clinical evidence of cerebral edema in children with DKA may be more common than previously reported. [source] Consideration of regional difference in design and analysis of multi-regional trials,,PHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 3 2010H. M. James Hung Abstract Clinical trial strategy, particularly in developing pharmaceutical products, has recently expanded to a global level in the sense that multiple geographical regions participate in the trial simultaneously under the same study protocol. The possible benefits of this strategy are obvious, at least from the cost and efficiency considerations. The challenges with this strategy are many, ranging from trial or data quality assurance to statistical methods for design and analysis of such trials. In many regulatory submissions, the presence of regional differences in the estimated treatment effect, whether they are different only in magnitude or in direction, often presents great difficulty in interpretation of the global trial results, particularly for the acceptability by the local regulatory authorities. This article presents a number of useful statistical analysis tools for exploration of regional differences and a method that may be worth consideration in designing a multi-regional clinical trial. Published in 2010 by John Wiley & Sons, Ltd. [source] Very low dose warfarin as prophylaxis against ultrasound detected deep vein thrombosis following primary hip replacementAMERICAN JOURNAL OF HEMATOLOGY, Issue 2 2002Murray M. Bern Abstract One mg daily warfarin was compared to variable dose warfarin (PT 1.3,1.5 times the normal PT), as prophylaxis against deep vein thrombosis (DVT) following unilateral hip replacement for degenerative joint disease (DJD). Ninety-eight patients entered onto study after having had negative color Doppler ultrasounds of the legs. Patients receiving 1 mg began therapy 7 days preoperatively and continued daily until discharge. Patients receiving the variable dose took 5 mg the night preoperatively, and thereafter daily based upon the daily PT. Seventy-eight patients completed the study protocol. No patient completing the protocol had DVT or pulmonary embolus (PE). Based upon intent to treat for all registered patients, one from each group had DVT after withdrawal from study. For patients receiving 1 mg warfarin daily, PTs extended none or slightly. Therefore, 1 mg warfarin can be used to prevent postoperative DVT following elective hip surgery. Am. J. Hematol. 71:69,74, 2002. © 2002 Wiley-Liss, Inc. [source] Prolonged Insulin Independence After Islet Allotransplants in Recipients with Type 1 DiabetesAMERICAN JOURNAL OF TRANSPLANTATION, Issue 11 2008M. D. Bellin We sought to determine the long-term outcomes in type 1 diabetic recipients of intraportal alloislet transplants on a modified immunosuppressive protocol. Six recipients with hypoglycemia unawareness received one to two islet infusions. Induction therapy was with antithymocyte globulin (ATG) plus etanercept for tumor necrosis factor-, blockade. Recipients received cyclosporine and everolimus for maintenance immunosuppression for the first year posttransplant, with mycophenolic acid or mycophenolate mofetil subsequently substituted for everolimus. Recipients have been followed for 1173 ± 270 days since their last infusion for islet graft function (insulin independence, hemoglobin A1c levels and C-peptide production) and for adverse events associated with the study protocol. Of the six recipients, five were insulin-independent at 1 year, and four continue to be insulin-independent at a mean of 3.4 ± 0.4 years posttransplant. None of the six recipients experienced recurrence of severe hypoglycemia. Measured glomerular filtration rate decreased from 110.5 ± 21.2 mL/min/1.73 m2 pretransplant to 82.6 ±19.1 mL/min/1.73 m2 at 1 year posttransplant. In conclusion, islet transplants restored insulin independence for a mean of >3 years in four of six recipients treated with ATG and etanercept induction therapy and with cyclosporine and, initially, everolimus for maintenance. Our results suggest this immunosuppressive protocol may allow long-term graft survival. [source] Complementary roles of prenatal sonography and magnetic resonance imaging in diagnosis of fetal renal anomaliesAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 3 2010Ibrahim A. ABDELAZIM Objectives:, This study was designed to assess the role of magnetic resonance imaging (MRI) in refining the diagnosis of prenatally suspected fetal renal abnormalities following screening ultrasound. Patients and methods:, Twenty pregnant women, with suspected fetal renal abnormality detected during screening ultrasound and more than 14 weeks' gestation, were included in this observational prospective study at Ain Shams University Maternity Hospital from March 2004 to March 2005 after informed consent and after approval of the study protocol by the institute ethics committee. Results:, The MRI could diagnose correctly 10 cases of hydronephrosis, one case of polycystic kidney disease (PCKD), one case of RA, two normal case and two cases of intra-abdominal masses (IA Mass) (16 of 18 cases). The prenatal ultrasound could diagnose correctly eight cases of hydronephrosis, one case of PCKD, one case of renal agenesis, one case of multicystic kidney disease and one case of IA Mass (12 of 18 cases). The prenatal ultrasound and MRI gave different diagnoses in eight cases and gave the same diagnosis in 12 cases. The MRI could diagnose the aetiology of congenital renal cysts in 10 of the 20 studied cases (50%). Conclusion:, Magnetic resonance imaging can be used as a complementary tool in the assessment of sonographically suspected fetal renal anomalies. [source] Carcinogenic potential of commonly used hernia repair prostheses in an experimental modelBRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 3 2004P. Witherspoon Background: The purpose of this study was to assess the carcinogenic potential of commonly used hernia repair prostheses in an animal model. Methods: Three types of prosthetic material (monofilament polypropylene, multifilament polypropylene and expanded polytetrafluoroethylene) were implanted in CBA/H mice. Flat (1 cm2) and rolled pieces of the same material were placed subcutaneously in either flank, and a further flat piece was placed in the preperitoneal space. Owing to a high incidence of mesh extrusion in the polypropylene groups, the study protocol was modified to allow only preperitoneal placement of the material. A fourth, control, group had the pockets for the prostheses created but no material implanted. After modification of the protocol there were approximately 60 mice in each group. The mice were followed for 2 years, then killed and assessed histologically for tumour development. Results: No sarcoma developed at the site of mesh implantation in any of the groups. Conclusion: This study indicates that the risk of sarcoma formation at the site of hernia repair prostheses is very low. Copyright © 2004 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Pediatric primary care to help prevent child maltreatment: the Safe Environment for Every Kid (SEEK) modelCHILD: CARE, HEALTH AND DEVELOPMENT, Issue 4 2009Richard Reading Pediatric primary care to help prevent child maltreatment: the Safe Environment for Every Kid (SEEK) model . DubowitzH., FeigelmanS., LaneW. & KimJ. ( 2009 ) Pediatrics , 123 , 858 , 864 . DOI: 10.1542/peds.2008-1376 . Context Effective strategies for preventing child maltreatment are needed. Few primary care-based programmes have been developed, and most have not been well evaluated. Objective Our goal was to evaluate the efficacy of the Safe Environment for Every Kid (SEEK) model of pediatric primary care in reducing the occurrence of child maltreatment. Methods A randomized trial was conducted from June 2002 to November 2005 in a university-based resident continuity clinic in Baltimore, Maryland. The study population consisted of English-speaking parents of children (0,5 years) brought in for child health supervision. Of the 1118 participants approached, 729 agreed to participate, and 558 of them completed the study protocol. Resident continuity clinics were cluster randomized by day of the week to the model (intervention) or standard care (control) groups. Model care consisted of (1) residents who received special training; (2) the Parent Screening Questionnaire; and (3) a social worker. Risk factors for child maltreatment were identified and addressed by the resident physician and/or social worker. Standard care involved routine pediatric primary care. A subset of the clinic population was sampled for the evaluation. Child maltreatment was measured in three ways: (1) child protective services reports using state agency data; (2) medical chart documentation of possible abuse or neglect; and (3) parental report of harsh punishment via the Parent-Child Conflict Tactics scale. Results Model care resulted in significantly lower rates of child maltreatment in all the outcome measures: fewer child protective services reports, fewer instances of possible medical neglect documented as treatment non-adherence, fewer children with delayed immunizations and less harsh punishment reported by parents. One-tailed testing was conducted in accordance with the study hypothesis. Conclusions The SEEK model of pediatric primary care seems promising as a practical strategy for helping prevent child maltreatment. Replication and additional evaluation of the model are recommended. [source] Secondary delusional parasitosis treated with paliperidoneCLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 3 2009R. W. Freudenmann Summary Second-generation antipsychotics (SGA) are increasingly used in primary and secondary delusional parasitosis (DP) because of their better overall tolerability compared with first-generation antipsychotics (FGA) such as pimozide. Controlled clinical trials with antipsychotics in DP are lacking, owing to difficulties in obtaining informed consent and in securing adherence to a study protocol by patients with DP. We present the case of an 88-year-old man with a 12-year history of DP secondary to leucoencephalopathy. After 9 days of an age-adapted dose of paliperidone, the patient no longer experienced the presence of vermin on his skin and stopped showering at night to get rid off of them. Paliperidone was well tolerated. At follow-up after 2 weeks, the DP was still remitted. Paliperidone appears to expand the therapeutic arsenal in treating DP with modern SGAs; however, this finding needs to be replicated. [source] Management of patients with non,ST-segment elevation acute coronary syndromes: Insights from the pursuit trialCLINICAL CARDIOLOGY, Issue S5 2000Dan J. Fintel M.D The glycoprotein (GP) IIb-IIIa inhibitor eptifibatide (INTEGRILIN®, COR Therapeutics, Inc., South San Francisco, California, and Key Pharmaceuticals, Inc., Kenilworth, New Jersey) is a novel and highly potent antithrombotic agent indicated for the management of patients with non-ST-segment elevation acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention. The approval of eptifibatide for non-ST-segment elevation ACS was based on the positive results of the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial. With enrollment of almost 11,000 patients, not only is the PURSUIT trial the largest trial of a GP IIb-IIIa inhibitor to date, but it is also the largest clinical study ever conducted in patients with non-ST-segment elevation ACS. The key feature of the PURSUIT trial is that patient management closely resembled standard clinical practice, because decisions about the use and timing of invasive cardiac procedures were made by the individual physicians rather than being prespecified in the study protocol. Eptifibatide therapy was associated with a significant reduction in the incidence of the primary endpoint,a composite of death or myocardial infarction at 30 days (14.2 vs. 15.7% in the placebo group; p = 0.042). Of importance is the fact that the beneficial effect of eptifibatide was independent of the management strategy pursued during study drug infusion (invasive or conservative), and it was achieved with few major safety concerns. These findings demonstrate that the use of eptifibatide should be considered for all patients presenting with signs and symptoms of intermediate- to high-risk non-ST-segment elevation ACS. [source] GH administration and discontinuation in healthy elderly men: effects on body composition, GH-related serum markers, resting heart rate and resting oxygen uptakeCLINICAL ENDOCRINOLOGY, Issue 1 2001Kai Henrik Wiborg Lange BACKGROUND AND OBJECTIVES GH administration results in increased lean body mass (LBM), decreased fat mass (FM) and increased energy expenditure (EE). GH therapy may therefore have potential benefits, especially in the elderly, who are known to have decreased function of the GH/IGF-I axis. Several studies have focused on effects of GH administration in the elderly in the last decade. However, very limited information is available regarding changes in body composition and EE upon GH discontinuation in the elderly. The present study therefore investigated the effects of 12 weeks of GH administration and subsequent discontinuation on body composition, resting oxygen uptake (VO2), resting heart rate (HR) and GH related serum markers in healthy elderly men. SUBJECTS AND METHODS Sixteen healthy men [age 74 ± 1 years (mean ± SEM), height 174·2 ± 1·6 cm, body weight 80·7 ± 2·6 kg, body fat 27·5 ± 1·1%] completed the study protocol. Recombinant human GH (1·80 ± 0·24 IU/day) was administered for 12 weeks in a single-blinded, placebo-controlled design. Body composition (dual energy X-ray absorptiometry), resting VO2 (indirect calorimetry), resting HR (telemetry) and serum IGF-I, IGF-II, IGFBP-3 and acid labile subunit (ALS) were measured at baseline, after 12 weeks of GH administration and, additionally in the GH group, 1, 2, 3, 4, 5 and 9 days after GH discontinuation. RESULTS Body weight was unchanged from baseline to 12 weeks in both groups. However, GH administration caused a decrease in FM (3·4 ± 1·0 kg, P < 0·012), paralleled by a similar increase in LBM (3·2 ± 0·4 kg, P < 0·0002). Resting VO2 and resting HR increased by 31 ± 3·6% and 7·3 ± 1·9 per minute, respectively, in the GH-group, where significant increases in serum IGF-I, IGFBP-3 and ALS also were noted. None of the above parameters changed in the placebo group. Within 2,3 days after GH discontinuation, the GH related serum markers and resting HR returned to baseline levels, whereas resting VO2 remained elevated even 9 days after GH discontinuation. In addition, GH discontinuation caused a significant decrease in body weight (1·86 ± 0·35 kg), derived exclusively from a decrease in LBM (1·63 ± 0·43 kg), while the decreased FM was maintained (12 weeks: 17·93 ± 1·65 kg, +9 days: 17·74 ± 1·62 kg). CONCLUSIONS The increases in serum IGF-I, IGFBP-3, ALS and resting heart rate induced by 12 weeks of GH administration in elderly men returned to baseline levels within 2,3 days after GH discontinuation. However, resting VO2 remained elevated for a longer period. GH administration reduced fat mass but maintained body weight by increasing lean body mass. In contrast, 9 days of GH discontinuation reduced body weight exclusively by reducing lean body mass. [source] | |||||||||||||||||||||||||||||||