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NCT ID: NCT01038219 Completed - FEVER Clinical Trials

Reliability of Subjective Assessment of Fever by Parents and Health Care Providers in Children and Adolescents

Start date: May 2010
Phase: N/A
Study type: Observational

Background: Fever is a widespread symptom in many diseases. Therefore, its value and diagnostic importance are well known. Fever in children is one of the common reasons for a visit to the pediatrician. Also, taking temperature is a very simple action and accessible to the general public. Temperature is measured in various parts of the body by using medical equipment. The type of method and thermometer varies according to the patient's age but often temperature is estimated by touch. Temperature measurement serves as a means for monitoring the patient's condition. For that reason, supervision of the body temperature is an important factor in the process of taking medical decisions. Study rationale: the parent is often asked if the child's temperature has been taken. The most frequent answer is: "I didn't measure, but I felt that he has a temperature". The few studies carried out on this subject showed that many parents used touch to evaluate the child's body temperature, especially in infants. Some studies checked the reliability of parents to estimate the child's body temperature by touch only. To the best of our knowledge, the reliability of medical staff (nurses) to estimate the child's body temperature by touch has never been studied. The aim of the current study is to investigate whether parents and nurses correctly estimate the child's body temperature by touch, as compared to thermometer measurement during the pediatric unit's routine work.

NCT ID: NCT01037686 Recruiting - Parkinson's Disease Clinical Trials

The Effect of Electrode Implantation for Deep Brain Stimulation (DBS) on Brain Function Using Single Photon Emission Computed Tomography (SPECT) With Technetium-99m-ethyl Cysteinatedimer (Tc-ECD)

Start date: February 2006
Phase: N/A
Study type: Interventional

The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during cognitive task performance or at rest.

NCT ID: NCT01037322 Completed - Ulcerative Colitis Clinical Trials

Cannabidiol for Inflammatory Bowel Disease

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects. The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.

NCT ID: NCT01035255 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

PARADIGM-HF
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).

NCT ID: NCT01035229 Completed - Carcinoma Clinical Trials

Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.

EVOLVE-1
Start date: April 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

NCT ID: NCT01035190 Completed - Clinical trials for Bronchopulmonary Dysplasia

Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

NEuroSIS
Start date: April 2010
Phase: Phase 3
Study type: Interventional

HYPOTHESIS: Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age (GA) by 10%. PRIMARY OBJECTIVE: To determine whether inhalation of Budesonide within 12 hours of life improves survival without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA. SECONDARY OBJECTIVES: To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a corrected age of 18-22 months in preterm infants; to determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support or supplemental oxygen. RATIONALE: Pre- and postnatal exposure of the developing lung to inflammation is central to the development of BPD and the pulmonary inflammatory response in preterms at risk of developing BPD is established very early in life. Corticosteroids have antiinflammatory properties and early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary system prior to the development of a full inflammatory response with a lower risk of undesirable systemic side effects. STUDY DESIGN: Randomised placebo-controlled, multi-centre clinical trial. RESEARCH PLAN: Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be defined according to the physiological definition. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months. CLINICAL SIGNIFICANCE: BPD not only contributes to the mortality of preterm infants but is also associated with impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent readmission to hospital in the first 2 years of life, as well as with an increased risk of asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

NCT ID: NCT01035138 Completed - Alzheimer's Disease Clinical Trials

A Study of Semagacestat for Alzheimer's Patients

Identity XT
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF). Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC and LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.

NCT ID: NCT01034969 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

Start date: July 10, 2009
Phase:
Study type: Observational

The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor [human]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor [human]) in routine clinical practice and as a data source for post-marketing investigations.

NCT ID: NCT01034722 Not yet recruiting - Clinical trials for Fat Globules in Breast Milk

Fat Globules in Breast Milk

Start date: December 2009
Phase: N/A
Study type: Observational

The aims of this study is: 1. To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet. 2. To study the changes in globules distribution along one session of lactation and during the day. Study design: Subjects: This will be a open label study. Each subject will serve as his own control. Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins. Each participant will be nursing a 2-5 months baby. Each participant will sign an informed consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the first nursing in the morning (in the beginning and at the end of the nursing session), and once in the evening on last nursing again, (in the beginning and at the end). Each sample will contain 5 ml of milk. Participants will be asked to repeat the procedure one month later.

NCT ID: NCT01034306 Completed - Clinical trials for Rheumatoid Arthritis

Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

Start date: October 2010
Phase: Phase 2
Study type: Interventional

This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at baseline will relieve signs and symptoms of the disease.