mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby. The secondary objectives of the study are to compare the following between the two arms of the study: A. The degree of postpartum maternal anxiety at day 1, day 7 and at hospital discharge. Anxiety will be compared point by point but also via kinetics. B. The incidence maternal post traumatic stress disorder at 6 and 12 months. C. The incidence of mother-child relationship disorders at 6 and 12 months. D. Infant vital signs during the hospital stay.
The purpose of this study is to evaluate if the developed theory and evidence based programme has a positive effect on mother's breastfeeding self efficacy, establishing an effective breastfeeding and breastfeeding duration after short time hospitalization.
In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined. After a research subject's death during an inhalation study using medications/drugs not approved for this route, the FDA prohibited human use of non-approved chemicals including capsaicin administered via inhalation. Capsaicin inhalation challenge tests (CICT) were performed on forty men of different ages utilizing pharmaceutical grade Capsaicin. Solutions were mixed by a registered pharmacist and Capsaicin doses, administered to subjects, were analyzed by high performance liquid chromatography (HPLC). Capsaicin solutions were stored in a refrigerator at 4 degrees C and shielded from ultraviolet light for 7 months. There was serial monitoring by spirometry and impulse oscillometry, electrocardiography, blood pressure, pulse and oxygen saturation measurements. There were no adverse reactions at any dose, including the highest capsaicin concentration.
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were separated by a washout period of 17 days during fasting study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
Smoking is a leading cause of death and other negative health outcomes. While a high percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months postpartum. We propose developing and pilot testing a phone-based postpartum continuing care (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation, reduce relapse, increase early re-intervention, and reduce infant exposure to environmental tobacco smoke in the postpartum period. The large majority of women who quit smoking during pregnancy relapse in the first six months postpartum, highlighting a need for effective postpartum continuing care that supports women through the challenging postpartum period when stress is high and motivation to stay quit may decline. Existing relapse prevention interventions (typically delivered during pregnancy) have been found to be of little benefit during the postpartum period, suggesting the need for a more formal continuing care approach. Phone-based protocols for smoking cessation have been widely disseminated and effective because they address the need for flexible access, but are passive and not typically utilized by women in the postpartum period. The proposed pilot study will develop and test a Phone-based Postpartum Continuing Care (PPCC) model that draws from existing evidence-based protocols--the 5 A's and Recovery Management Checkups (RMC)-- shown to be effective with other populations. The experimental PPCC will reinforce the importance of abstinence, relapse prevention, and reduced smoking through proactive re-intervention (i.e., RMC) with the 5 A's at times when postpartum women are more likely to relapse, and provide education and monitoring of the infant's direct and indirect exposure to nicotine through breastfeeding and secondhand smoke.
Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess weight gain puts mothers at risk for health problems such as diabetes and developing or sustaining obesity after pregnancy, and puts their babies at risk of being born too large or developing related health problems. Mothers will be randomized to a structured high dairy protein diet and walking program or the usual care by their care provider. The investigators research questions are: Will a structured nutrition and exercise program in pregnancy compared to usual prenatal care increase the chance that mothers will achieve pregnancy weight gain within the current recommendations; improve health measures, in mother and infant at six months post-partum; to evaluate the benefits of a high dairy intake in pregnancy on maintenance of bone status in the mother and bone health outcomes in the child in early life (6 months); and to investigate the interactions between genes associated with bone health and high dairy diet supplementation on bone status in mothers during pregnancy, and bone health in mothers post-delivery and children to 6 months of age. Mothers' weight, physical activity and adherence to the nutrition plan will be assessed until birth and at follow-up with their infants at 6 months after birth. The research team will ensure new information is quickly transferred to programs to assist women to have healthier pregnancies.
Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.
This is a prospective, multicenter single arm, nonrandomized study that will include 150 patients at a maximum of 20 investigational sites. It is estimated that it may take 13 months to complete enrollment. Follow-up will continue through 24 months post-implant or one month post-retrieval, whichever occurs first. It is required that filters be retrieved from at least 50 patients and the filter is permanent in at least 50 patients. Verify the effectiveness and safety of the Veniti IVC Filter in accordance with the clinical guidelines published by the Society for Interventional Radiology (SIR) . The endpoint is clinical success (versus failure) at 6 months after implant or 1 month post retrieval, whichever occurs first, based on the definition provided by the SIR guidelines, as the absence of: 1. Procedure failure (assessed at the end of the implant procedure) 2. Subsequent pulmonary embolus 3. IVC occlusion 4. Filter embolization Secondary assessments include: Estimating the rate of: 1. Retrieval success 2. Device and procedure related adverse events 3. Assessing filter performance rate: c1.Filter migration c2.Filter fracture c3.Filter Tilt
This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy. Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.
Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid. The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN. The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo.
The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude. This randomized cross-over trial evaluates the hypothesis that patients with chronic obstructive pulmonary disease experience nocturnal hypoxemia, periodic breathing and sleep disturbances when staying at moderate altitude. Sleep studies and clinical evaluations will be performed during 2 days in Zurich (490 m, low altitude baseline) and during 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m).
With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could be done with less than the usual 80-120 ml of contrast used. We have developed a method of performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most patients. The long-term objective of this study is to show that there is no difference in the diagnostic efficacy of this low dose 30 ml technique when compared to the more traditional full-dose technique. Potential participants in the study will have been referred to the radiology section for a CTPA for a suspected pulmonary embolus. The radiologist will review the patient's record in CPRS, as is done routinely in this situation. Patients with class 3 or 4 CHF, supraventricular tachycardia, Serum Creatinine >1.5 mg/dl (>1.3 mg/dl female), history of contrast allergy, or unable to give informed consent will be excluded from both arms of the study. Patients with serum creatinine >1.28 mg/dl require referring physician approval. If the participant appears to qualify for the study then the study physician will contact the referring physician and inform him/her of the study. If the referring physician is agreeable then either the radiologist or the referring physician will approach the patient, either at the bedside or in the radiology clinic to determine if the patient is interested in participating in the study.
Background: Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending pressure and therefore small tidal volume. Animal studies showed that recruitment and maintenance of functional residual capacity (FRC) during HFOV ("open lung concept") could reduce lung injury. "Open lung HFOV" is achieved by delivering a moderate high mean airway pressure (MAP) using oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung recruitment. This has however to our knowledge not been tested in a clinical trial using modern ventilators. Purpose, aims: - To compare HFOV-sigh with HFOV-only and determine if there is a difference in oxygenation expressed as a/A-ratio and/or stability of oxygenation expressed as percentage time with oxygen saturation outside the reference range. - To provide information on feasibility and treatment effect of HFOV-sigh to assist planning larger studies. We hypothesize that oxygenation is better during HFOV-sigh. Methods: Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4 alternating 1-hours periods (2-treatment, double crossover design, each patient being its own control).
Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Those studies showed that even very small babies can be safely supported using nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to breath, albeit with additional support to reduce their work of breathing. However nCPAP has some drawbacks, including that it can cause skin damage to the nose, and that the heating and humidification of the gas is not always sufficient. We have been using, for over 5 years, a different system to support babies after routine intubation. This is another type of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior to nCPAP in respect it does not cause nose damage and its heating and humidification is excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation.
Study hypothesis: Childbearing couples who receive the father inclusive psychoeducation program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year postpartum than those who receive the usual perinatal care. Background: Having a first child is a key marker of the transition into parenthood that requires substantial adjustment of couples' life. A recent meta-analysis published in the Journal of American Medical Association reports that both women (23.8%) and men (10.4%) suffer from perinatal depression [1]. The father's involvement during pregnancy can positively influence health outcomes not only for the man, but his partner, and their children [1,2]. However, the effectiveness of father's involvement in prenatal care in preventing paternal and maternal depression, is still unknown. Aims: This study seeks to: (1) evaluate the effect of a father inclusive psychoeducation program for first-time Chinese mothers and fathers on depressive symptoms (primary outcome), marital relationships and quality of life at 6 weeks, 6 months and one year postpartum; and (2) explore fathers' involvement, their perceived benefits of participating in the program and factors influencing the effectiveness of the program. Methods: This study employs a longitudinal, randomized, pre and post-test design.
The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life. The effect will be assessed by the milk and blood.
To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.
The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with pulmonary hypertension or with interstitial lung disease. Patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), breathing and sleep during a 2 day sojourn at moderate altitude are impaired in comparison to low altitude; b), breathing and sleep during a 2 day sojourn at moderate altitude are improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (St. Moritz Salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low altitude (<800 m). The order of stays at the different altitudes and of the treatments will be randomized.
This is a prospective, randomized, controlled cohort study. This study will look at the effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20 mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when compared to a control group using no hormonal contraception. Depressive symptoms and sexual function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W). Participants will begin taking the medication at Week 3 postpartum, and these outcomes will be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and increase in sexual function in both of the oral contraceptive groups.
The study's purpose is to determine if early (2-3 week) versus traditional (6-8 week) postpartum follow up is associated with a higher rate of breastfeeding at 6 months. The study's hypothesis is that follow up at 2-3 weeks postpartum is associated with a higher rate of breastfeeding 6 months postpartum. This study is a non-blinded randomized controlled trial with intent to treat analysis intended to determine whether early (2-3 weeks postpartum-experimental arm) versus traditional (6-8 weeks postpartum-control arm) follow up increases breastfeeding rates at 6 months' postpartum. For purposes of this study, breastfeeding will be defined as any breast milk produced by the mother and fed to her infant (whether by placing the infant to the breast or pumping/expressing milk and feeding it to the infant in another way). A literature search failed to identify any study that evaluated benefits or shortcomings of an exclusive short interval postpartum visit instead of the 6-8 week traditionally timed visit. Although there may be practical reasons to delay postpartum follow up until 6-8 weeks after delivery, there is no good data to support this, and it may remain the dominant practice due solely to convention. Recent expert opinion has suggested that earlier postpartum follow up may be more practical and provide an earlier or more convenient opportunity to provide assessment and education to postpartum women [9]. Earlier follow up may present a more timely opportunity to discuss family planning, breastfeeding, and screen for depression.
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in another study. The National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, is funding this follow-up study of the nuMoM2b cohort to evaluate the association between adverse pregnancy outcomes (APOs) and cardiovascular health approximately 2 to 3½ years postpartum. The study, called the nuMoM2b Heart Health Study or nuMoM2b HHS, utilizes the extensive database and tissue bank developed for nuMoM2b in which nulliparous women are evaluated over the course of pregnancy to study the mechanisms for and prediction of APOs. Women enrolled in the nuMoM2b cohort are extremely well phenotyped through prospective data collection, clinical evaluations, and ultrasound assessments, as well as through the use of standardized definitions. Demographic, psychosocial, dietary, physiologic, and outcome information were collected through maternal interviews, self-administered questionnaires, clinical measurements, ultrasounds, and medical record abstraction. Samples of maternal blood, urine, and cervico-vaginal fluid over pregnancy and cord blood and placenta at delivery were collected and banked. All women completed two sleep questionnaires and over 3,600 had objective overnight sleep studies at two times during pregnancy.
Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in significant morbidity, mortality and resource utilization. The true incidence is unknown, and may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in thoracic surgery includes administration of unfractionated or low molecular weight heparin starting at the perioperative period and finishing at the time of patients' discharge. In orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become the standard of care. There is a clear need to systematically evaluate the incidence of VTE after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung resections. This study will involve patients undergoing lung resection for malignancy at St. Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital. The study will include 150 consecutively recruited patients. Study interventions will include Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery. In summary, this study is aimed at evaluating, for the first time in a prospective manner, the actual incidence of DVT and PE in patients undergoing major lung resections for malignancies. The knowledge gained in this study will be used to inform a future investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an evidence-based practice change in VTE prophylaxis care for this high risk population.
PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings. The current oxytocin regimen requires the administration of a continuous infusion to achieve sustained uterotonic activity, which can be associated with a number of side effects and unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy, with a similar side effect profile to that of oxytocin. In addition, some studies have also shown that there is less blood loss and less requirement for additional uterotonic drugs when carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin.
There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have received the drug before birth. If the patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other anticonvulsant drugs. This study can be conducted in 12 maternity latin america. The final treatment known for pre-eclampsia and eclampsia is the termination of pregnancy. However to prevent eclampsia in patients with severe pre-eclampsia has been demonstrated the effectiveness of magnesium sulfate. There are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe disorder of blood pressure during pregnancy. These studies used the drug before birth and continue after birth. Therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure. If the cure or definitive treatment of pre-eclampsia is the interruption, did not seem necessary to justify the administration of drugs anti-eclampsia after birth. Obvious post delivery management with magnesium sulfate arises from the large number of postpartum eclampsia reported in many studies. It is unknown whether administration of magnesium sulfate for a minimum period before delivery, requires even keep the drug post partum.
The uptake of postpartum contraception, postpartum care attendance and the practice of exclusive breastfeeding are low in Sub-Saharan Africa. Although the involvement of men in maternity care has been shown to be a promising strategy for the achievement of other reproductive health goals, little is known about the effect of their participation on these outcomes. This study aims to test whether the involvement of men can improve care-seeking and promote healthy behaviours among postpartum women in Burkina Faso. There is a paucity of evidence on strategies to increase the uptake of postpartum contraception and attendance at facility-based postpartum care in developing countries, including in Sub-Saharan Africa. There is also a need to test new solutions to improve adherence to recommended infant feeding practices in these settings. Partner opposition is a major barrier to women's uptake of contraceptive methods in the postpartum period in Burkina Faso, and research has shown the need to sensitise and inform men about a broad range of topics related to reproductive health. However, the effect of involving male partners on women's and newborns' health and wellbeing in low-resource settings is not well known, and there is particularly little evidence for outcomes related to the postpartum period. The aim of this study is to assess whether male partner involvement in maternity care has the potential to increase care-seeking and promote healthy behaviours among postpartum women in an urban West-African setting. A randomized controlled trial (RCT) of an intervention to promote the involvement in maternity care of the partners of pregnant women attending primary health care facilities will be conducted in the city of Bobo-Dioulasso.
The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia in pre-school children in resource limited settings are controversial both at an individual and public health level. Most infections are viral or self-limiting and non-selective drug treatment has contributed to the global epidemic of antibiotic resistance. There is no high quality trial evidence in managing children with fast breathing in community settings and the WHO itself has called for evidence on which to update guidance. The investigators proposed non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum settings in South Asia to address this deficit. Pneumonia is a major cause of illness and death in children in low-income countries. With a view to decreasing death from pneumonia, the World Health Organization and UNICEF developed the Integrated Management of Childhood Illness (IMCI) algorithm which simplifies management of common childhood illnesses such as pneumonia and diarrhea into different levels of severity for determining the most appropriate case management by primary healthcare providers. Many pneumonia cases are categorized as non-severe pneumonia (defined as fast breathing above the specified age cut-off for respiratory rates). As there is incomplete information regarding the cause of this type of "pneumonia" from primary care settings, treatment guidelines by WHO are dictated by culture information from hospital pneumonia cases which are different in severity and cause. Current WHO guidelines advocate the use of oral antibiotics for fast breathing pneumonia.
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one. This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates. Dental support device is effective in increasing isometric force in different muscle contraction [1-7]. In 2009 an avant-garde study [8] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal. Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one. This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead space. Sound waves are used in various industries to accelerate the process of mixing or separating fluids (gases/liquids). We have proved that certain sound waves can safely improve gas exchange in the lung of rats through accelerating gas diffusion inside their airways and alveoli. Now we want to see if similar sound waves can improve gas exchange in humans. The device which creates the sound waves is a sonic pressure oscillator capable of making sound waves similar in loudness and frequency to loud human singing or screaming. These waves are mainly in the frequency range of 50-500 Hz (Hertz, oscillations per second) with intensity of 85-105 dBs (deci Bells, unit of sound pressure intensity). We performed two bench top studies and witnessed the ability of sound waves to augment gas diffusion. In a pilot study in rats we showed a safe and significant improvement in pulmonary gas exchange under influence of sound energy. The effects of sound waves on gas exchange in a human subject, the principle investigator (PI), was also analyzed in a metabolic test with promising results. A clinically significant improvement in the PI's pulmonary gas diffusion was also noted in a DLCO (diffusing lung capacity for carbon monoxide) test. On yet another test, artificially enlarged pulmonary dead space study, the PI's transcutaneous oxygen and carbon dioxide pressures (PtcCO2 & PtcO2) were measured and results were indicative of presence of desired and safe effects of particular sound waves in pulmonary gas exchange.
Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, in order to make clear whether can improve the prognosis. Experimental evidence repeatedly demonstrated that the shock patients can use substrates other than glucose to sustain increased activity, including lactate.Increased lactate can be the consequence of anaerobic metabolism, i.e., the formation of lactate in the presence of low oxygen. However, emerging evidence demonstrated that in patients with sepsis increased lactate seems predominantly non-hypoxic/ischemic and rather the consequence of increased glycolysis. Utilization of lactate as an alternative fuel may be an adaptive response to maximize energy function and limit substrate reduction.Uptake of exogenous lactate has indeed been demonstrated after traumatic brain injury and acute heart failure in humans. The investigators assume that administration of supplemental lactate significantly contributes to energy metabolism in septic shock, which can have beneficial help for septic shock resuscitation. Inclusion criteria:diagnosis in patients with septic shock and age 18 years old or more. Exclusion criteria: pregnant women and nursing mothers, severe liver failure with child class C , use linezolid anti-infection treatment, pheochromocytoma patients, CVVH therapy patients, malignant tumor patients, using epinephrine. The investigators will use sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, the organ function monitoring include heart, kidney,and brain. Others study endpoints include 28-day mortality,hospitalized mortality.
This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement. Anemia is common following delivery. It is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. International guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. However, patient's compliance after delivery is low, making the administration of several doses difficult. In those cases oral iron supplements might be used. In the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
The intent of this study is to determine the difference in pharyngeal oxygen concentration in patients who have a natural airway (not intubated) using commonly available oxygen delivery systems. The investigators will test the hypothesis that oxygen concentration during the period of inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at high flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen concentration at subjects' lips and pharynx when breathing 100% oxygen and room air via a simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson Rees circuit. A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%. With a significance criterion of 0.05, 10 subjects would provide more than 90% power to detect a mean difference of 10%. Oxygen therapy refers to the administration of oxygen at higher concentrations than room air. According to the most recent American Association for Respiratory Care Clinical Practice Guidelines, indications for supplemental oxygen include hypoxemia, severe trauma, acute myocardial infarction, short term therapy, and postoperative recovery. Though there are few contraindications to oxygen therapy, potential complications exist, including ventilatory depression in hypercarbic patients, absorption atelectasis, and oxygen toxicity (particularly in some patients receiving specific chemotherapeutic agents).
Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating PND, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating PND. Singing away the Blues is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music. The study uses an online questionnaire to achieve a cross-sectional view of the mental health of women across England in the final stages of pregnancy and the first 9 months post birth, how much and in what ways music is used by these women, and whether there are any associations between music and mental health. The study aims to recruit 1,000 women to take the anonymous questionnaire. However, women who complete the questionnaire while still pregnant will be invited to complete three further questionnaires shortly post-birth and 3 months later to gather longitudinal data to analyse change across pregnancy into post-birth (aiming for 500 of the 1,000 undertaking this repeated measurement).
Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of these patients. The application of a protocol for assessing the risk of VTE reduces mortality and morbidity of these phenomena. Thromboembolic events are among the leading causes of maternal morbidity and mortality in pregnancy / postpartum period. They are the leading cause of maternal death in developed countries. Risk factors for venous thromboembolism (VTE) during pregnancy and postpartum as family history or personal history of VTE, thrombophilia, age over 35, obesity and high parity has been the most studied. One of the main risk factors is hospitalization, which increases up to 20 times the risk of VTE. Objective: The objective of the study is to identify early risk factors for VTE in hospitalized pregnant women and institute appropriate prophylaxis to reduce the incidence and morbidity. Methods: A prospective study that will evaluate all pregnant women admitted for clinical treatment and / or surgery in the Department of Obstetrics and Gynecology, Clinics Hospital, University of São Paulo through the application of a thromboprophylaxis protocol with risk assessment score. The patient in whom prophylaxis would be indicated are those with scores greater than or equal to 3. The drug to be used is enoxaparin and the dose to be used depends on the weight of the patient. It will be further assessed: adverse effects of treatment with enoxaparin, protocol failure in the group treated and untreated (without anticoagulation) and bleeding incidence in the untreated group.
We previously showed that a gentle chest pressure technique could be used on children over a year old to generate around 20% of the volume of air inhaled or exhaled in a single normal breath (also known as tidal volume). This showed that a non-invasive method could be used to provide a temporary means of artificial breathing, meaning that invasive procedures, such as putting in a breathing tube, could be avoided. What our results did not tell us, however, is how much oxygen can get to peripheral tissues (e.g., arms, legs) with this method. In this study, we want to compare two groups of children. All children will have a breathing tube; one group will have gentle chest pressure performed on them to see if oxygen saturations can be maintained above 90%. The other group will receive no chest pressure. We will see how long it takes for oxygen levels in both groups to drop to 90%, at which point, the patient will be ventilated mechanically. BACKGROUND Airway management is different in the pediatric population compared to adults mainly due to the differences in respiratory physiology and anatomy. The oxygen consumption is about three times as high in children than in adults resulting in a higher impact on oxygen delivery and reserve should there be a problem with ventilation in children. During inspiration, the vertical dimension of the chest cavity is increased and the rib margins are lifted and moved out, causing an increase in the transverse diameter of the thorax.
The purpose of this study is to determine whether systematically performing computed tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during the venous phase of opacification) in addition to thoracic CT angiography in women with suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism detection rate. Pulmonary embolism (PE) remains a leading cause of maternal death during postpartum in developed countries; Thoracic computed tomography angiography (CTA) is the first-line diagnostic test for PE suspicion, but has a 20 to 35% rate of inconclusiveness during pregnancy and postpartum, 2 to 3 times higher than that of the general population. CT venography (CTV) consists in a delayed CT acquisition of the abdomen, pelvis and lower limbs, 3 minutes after starting contrast administration. It can be used for detecting deep venous thrombosis (DVT), the source of emboli in most PEs. The investigators hypothesized most postpartum PEs are due to pelvic vein thrombosis and that detecting such pelvic DVT by performing systematic CTV could increase the overall venous thromboembolism (VTE) detection.
Vitamin D deficiency is common in the elderly and contributes to the increased incidence of falls, hip fracture and depression in this population. An unknown number of elderly have vitamin D resistance resulting in a functional vitamin D deficiency state. Because there are no simple procedures or blood tests that identify vitamin D resistance, its prevalence and contribution to disability in the elderly is unknown. Our inability to screen for this condition precludes our ability to initiate and monitor treatment. Previous studies indicate that fingernail thickness correlates with vitamin D status and may therefore provide a simple cost effective procedure to not only identify patients with vitamin D deficiency but also, those with vitamin D resistance. This procedure may also provide a way to monitor an individual's response to treatment. This study is designed to demonstrate the association between fingernail thickness and vitamin D status.
The main goal of this project is to use imaging and biomarkers to identify cognitively normal elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease (AD). The second goal of this project is to describe the inter-relationships among anatomical biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people who develop MCI. The goal of this project is to use magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) biomarkers to identify cognitively normal participants who show the earliest clinically detectable brain changes of Alzheimer's disease (AD). The major hypothesis for this study is that CSF P-tau231 measurement improves the accuracy of MRI and cerebrospinal fluid (CSF) measurements in predicting mild cognitive impairment (MCI). Validation of this hypothesis can lead to improved diagnostic tools for detecting AD as early as possible. This 5-year longitudinal study will involve a baseline exam and two 18-month followup exams. Participants will undergo MRI scans, CSF collection and blood samples, neuropsychological performance testing, and medical, neurological and psychiatric assessment. The screening and diagnostic evaluations will be carried out by the New York University Alzheimer Disease Core Center (ADCC) and the NYU Center for Brain Health. This study will enroll a minimum of 80 cognitively normal participants, 60 to 80 years of age, with English as their first language, with about 12 years of formal education, and who are living in the metropolitan New York City area.
The purpose of this study is to explore the efficacy of a perioperative daily dose of Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium. Delirium is confusion or a sudden change in alertness which may happen after hip repair surgery. Up to 65% of elderly undergoing surgical repair of hip fracture experience post-operative delirium. These individuals often stay in the hospital longer, have more complications, and are more likely to die. Early studies suggest that delirium could be prevented by correcting the central cholinergic deficit that is associated with delirium. Donepezil is currently being used to treat memory loss in patients with Alzheimer's disease. This study will recruit 30 adults aged 65 or older who are undergoing hip fracture surgery. Participants will be randomized to receive either Donepezil or a matching placebo within 24 hours prior to surgery and for 4 days after the surgery. All material to be collected will be from interviews, questionnaires, and medical chart review at baseline and daily for the entire hospital stay. The Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS) will be used to evaluate the effect of Donepezil on delirium incidence and severity. Other assessments include cognitive deficit, length of hospitalization, discharge site, adverse effects, and psychotropic medications.
It has been suggested that cognitive functioning is impaired in chronic pain patients. Since most of these pain patients engage in daily activities including driving, it was hypothezised that they may have an increased risk of becoming involved in traffic accidents. Most chronic pain patients engage in daily activities including driving. Driving a car is a complex task requiring mental alertness and a variety of cognitive functions such as perception, attention, learning, memory and decision making.Several studies have demonstrated cognitive impairments on laboratory tasks in patients with chronic pain, particularly on measures assessing attentional capacity, processing speed and psychomotor speed. These findings suggest that car driving performance might be impaired, and that chronic pain patients may therefore have an increased traffic accident risk. Unfortunately, no studies have investigated the impact of chronic pain on actual driving ability. The present study was designed to investigate the effects of chronic pain on actual driving performance during normal traffic. In addition to the on-the-road driving test, psychomotor, and memory tests measuring driving-related skills were conducted in the laboratory. Moreover, effects of pain on an attentional capacity test were tested using event-related potentials.