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NCT ID: NCT00945022 Not yet recruiting - General Surgery Clinical Trials

Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting

Start date: October 2011
Phase: N/A
Study type: Interventional

Following waking up from surgery performed under general anesthesia, patients are suffering from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours. The current management involves the wetting of patient's lips using wet bandage. This action is dependent on the presence of a family member or a nurse, which is not always possible. Many patients describe the oral dryness as a suffering, added to the suffering anyway entailed by surgery. The investigated Lipsus device is intended for oral wetting, relieving patient's suffering and minimizing the dependence on continuous presence next to patient's bed.

NCT ID: NCT00938509 Not yet recruiting - Fever Clinical Trials

Ibuprofen Suppositories Administration in Infants and Children

Start date: July 2009
Phase: Phase 4
Study type: Interventional

The study will evaluate the efficacy of Ibuprofen administered as suppositories in the treatment of fever in infants and children. Ibuprofen as suppositories is not yet registered in Israel, although widely used in Europe.

NCT ID: NCT00933751 Not yet recruiting - Abdominal Surgery Clinical Trials

Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome

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

Tissue hypoxia is one of the most important factors leading to the development of multiorgan failure. Patients presenting for emergent major abdominal surgery might suffer from organ hypoperfusion. Thus, early detection of the imbalance between oxygen supply and demand may improve the outcome. The investigators believe that hypoperfusion of the abdominal organs will cause a decrease of the saturation in the hepatic vein and in the IVC.

NCT ID: NCT00931099 Not yet recruiting - Pregnant Women Clinical Trials

Fetal Outcome of Sleep Disordered Breathing During Pregnancy

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

Sleep disordered breathing (SDB) is a frequent disorder characterized by some combination of repeated events of partial or complete upper airway obstruction during sleep, disruption of normal ventilation, hypoxemia, and sleep fragmentation. When untreated, SDB is associated with serious cardiovascular and neurobehavioral morbidities. Many physiologic changes that occur during pregnancy may compromise the respiratory system and place women at risk for developing SDB. Indeed, snoring has been reported in up to 46% of pregnant women. Preliminary evidence suggests that SDB is associated with the hypertensive conditions of pregnancy and that oxidative stress and endothelial dysfunction are mechanisms important in the development of both conditions. Moreover, early reports in animals and in humans suggest that maternal SDB may affect the developing fetus and that the intermittent hypoxia and increased sympathetic activity induced by SDB could potentially contribute to adverse maternal-fetal outcome. However, previous reports have focused on crude and non specific measures of fetal outcome such as birth weight and APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score and currently there is no data on the mechanisms underlying the adverse effect of maternal SDB on the fetus and the newborn infant. Hypothesis: SDB during pregnancy imposes a risk to the developing fetus and the newborn infant through mechanisms mediated by maternal hypoxia. Objectives: 1. To prospectively investigate the incidence and severity of SDB during pregnancy using an objective tool, i.e., overnight polysomnography (PSG) or at-home sleep study using portable device in a large cohort of pregnant women. 2. To examine the effect of maternal SDB on fetal and neonatal outcome. Methods: 300 women in the third trimester of a singleton uncomplicated pregnancy, who attend a low risk obstetric surveillance will be recruited. Hundred women hospitalized at the Antenatal department due to pregnancy related hypertensive disorder, intrauterine growth restriction (IUGR), diabetes mellitus or premature labor will also be recruited. In addition, 200 women of a singleton uncomplicated pregnancy will be recruited during labor at the delivery room. All participants will be asked to complete a designated sleep questionnaire. Based on the questionnaires, women in the third trimester will undergo a sleep study. Medical records review will be conducted after delivery and will include information of maternal blood pressure, labor duration, route of delivery, infant birth weight and APGAR score. Placentas will be collected immediately after delivery from all women. Cord blood will be obtained immediately after delivery and will be analyzed. Post-natal neurobehavioral evaluation will be conducted. Data analysis will be performed on 4 population subgroups: (1) Sleep study proven SDB, (2) Sleep study proven non-SDB, (3) SDB per questionnaire, (4) non-SDB per questionnaire. Comparisons of fetal outcome measures according to group assignment will be performed. In addition, the association between the severity of SDB based on sleep studies (degree of hypoxemia, degree of sleep fragmentation, amount of respiratory events) and outcome measures will be performed.

NCT ID: NCT00928213 Not yet recruiting - Preeclampsia Clinical Trials

PP13 and Doppler Study to Predict Preeclampsia

Start date: August 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Assessment of biochemical and sonographic marker to predict the risk for developing preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and Placenta Growth factor (PIGF). For sonographic marker Doppler pulsatility Index of the blood flow through the uterine maternal arteries is assessed. PP13 is produced by the placenta and released to the maternal blood circulation. It has been shown to be an effective serum marker for early onset preeclampsia (Nicolaides KH et al., 2005). The purpose of this study is to combined the assessment of the biochemical markers with Doppler in the first and the second trimester to provide a comprehensive evaluation of various methods for sequential and combined analysis to assess the risk for developing preeclampsia.

NCT ID: NCT00919919 Not yet recruiting - Endometrial Cancer Clinical Trials

Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

Start date: June 2009
Phase: Phase 2
Study type: Interventional

The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.

NCT ID: NCT00918528 Not yet recruiting - Urethral Stricture Clinical Trials

Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy

Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.

NCT ID: NCT00917332 Not yet recruiting - Pain at Childbirth Clinical Trials

Effects of Relaxation and Guided Imagery Training on Pain at Childbirth

Start date: August 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether relaxation and guided imagery techniques are effective in reducing childbirth pain.

NCT ID: NCT00914784 Not yet recruiting - Dyspnea Clinical Trials

The Incidence of TRALI in Patients Undergoing Orthopedic-Oncology Surgery

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

Currently Transfusion-related acute lung injury (TRALI) is the leading cause of transfusion-related mortality in the United States, and one of major post-transfusion complications. TRALI is defined as new ALI occurring within 6 hours from the onset of transfusion. It is manifested by acute dyspnea, hypoxemia and bilateral infiltrates in chest radiograph. TRALI may be caused by any blood product and is not dose-dependent. Associated risk factors include prolonged storage of blood products and underlying conditions such as severe IHD hematologic malignancies or active infections. Since TRALI has only recently been defined as a clinical entity, and its prevalence has been largely underestimated - the epidemiology of TRALI is not well established. Therefore the objective of this work is to study the incidence of TRALI in a patient population that receive blood products frequently, namely orthopedic-oncologic.

NCT ID: NCT00909376 Not yet recruiting - Pregnancy Clinical Trials

Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?

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

Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. In the transvaginal ultrasound there is some amount of version of the fetus done by the examiner to maintain a better aspect of the fetus, while this is not done in a transabdominal sonography. The objective of this trail is to determine whether having a transvaginal ultrasound as opposed to a transabdominal one has an association to adverse perinatal outcomes.