A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.

A number of strategies have been evaluated to improve clinical outcomes in diabetics patients, however no studies explored the efficacy of a nurse-led reminder program through email (NRP-e) to improve medication adherence, even if it is fundamental in the management of diabetics. The study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (NRP-e) to improve medication adherence in diabetic patients.

This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

Caregiver: If you agree to take part in this study, your demographic information (such as your age, sex, and race) will be recorded. You will then be assigned to 1 of 2 study groups: * If you are in Group 1, you will take part in the couple-based Hatha Yoga program. * If you are in Group 2, you will not take part in the couple-based Hatha Yoga program but will complete the same study procedures as Group 1. You will be given the option to take part in the couple-based Hatha Yoga program (off study) after you finish your last questionnaire packet. You and the patient will have about a 1 in 2 chance of being assigned to each group (as in the flip of a coin). The groups are randomly assigned, but the assignment will also depend on the age, sex, and status of disease of the patient. Yoga Sessions: If you are in Group 1, you will take part in up to 15 sessions of Hatha yoga with the patient over the course of radiation therapy (2-3 weekly sessions). Each 45- to 60-minute session will be guided by an instructor. You should attend each session with the patient. During the yoga sessions, you will be asked to do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any question you may have about the practice of Hatha yoga. Most of the yoga sessions may be videotaped. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to view this videotape. The video files are digital and will be deleted after all the data are studied. At your fifth session, you will be given a CD and instructions for practicing Hatha yoga at home. While the patient is receiving radiation therapy, you will be asked to practice at home 1 time a day either with him/her or alone on the days you do not have a session at the clinic. Your answers to the questions will not be shared with the patient. During each week of radiation therapy, you will also complete a questionnaire about your feelings about the Hatha Yoga sessions. You will be asked to list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice outside of class and if you think you are benefitting from the Hatha Yoga program. It should take about 5 minutes to complete this questionnaire. Questionnaires for All Study Participants: You will complete about 10 questionnaires before the patient\'s first radiation treatment, at the end of the treatment (usually 6 weeks later), and then again 3 months later. The questionnaires have questions about your mood, your quality of life, your feelings about being a caregiver, and your relationship with the patient. It should take about 45 minutes to complete these questionnaires each time. You will also complete about 5 questionnaires halfway through the radiation treatment schedule. These questionnaires have questions about your quality of life. These should take about 20 minutes to complete. Saliva Testing for All Study Participants: After your first visit, at the end of the patient\'s radiotherapy, and 3 months after the radiation, you will be asked to provide saliva samples to measure the level of cortisol (a stress hormone). These saliva samples will be collected 4 times a day for 2 days in a row. You will be asked to collect the samples when you first wake up, about 45 minutes later, about 10 hours after waking, and then at bedtime. To collect each saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will write down the times at which you took these samples. You will then either bring the samples into the clinic or mail the samples back to MD Anderson in postage-paid envelopes that will be provided to you. The supplies needed for this testing will also be provided at no cost to you. These saliva samples will be destroyed after being studied. Follow-Up Phone Calls: If you are in Group 1, after you have completed the weekly yoga classes, you will receive phone calls from a study team member asking about your at home Hatha Yoga practice. You will be called every other week between the end of your radiotherapy and your final visit with the study. This will be about 5-6 phone calls and they will last approximately 10 minutes each. Length of Study: Your participation on this study will be over when you have completed the questionnaires at the time of the patient\'s 3-month follow-up appointment in the thoracic clinic. This is an investigational study. Up to 50 patients and their family members, for a total of 100 participants, will take part in this study. All will be enrolled at MD Anderson. Patients: If you agree to take part, your medical history and demographic information (such as your age, sex, and race) will be recorded. By signing this consent, you also agree that your caregiver will be approached to take part in this study. After your first visit, you will be randomly assigned (as in the roll of dice) to 1 of 2 groups: * Group 1 will take part in the couple-based Hatha Yoga program. * Group 2 will not take part in the couple-based Hatha Yoga program but will complete the same procedures as group 1. Participants in this group will be given the option to take part in the couple-based Hatha Yoga program (off study) after they finish their last questionnaire packet. Group 1: Hatha Yoga Sessions: You and your caregiver have a 50/50 chance to be assigned to the intervention group or to the usual care group. If you are assigned to the intervention group, you will take part in up to 15 sessions of Hatha yoga over the course of radiation therapy (2-3 weekly sessions). Each 45- to 60-minute session will be guided by an instructor. You should attend each session together as a couple. During the yoga sessions, you will be asked to do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any questions you may have about the practice of Hatha yoga. Most of the yoga sessions may be videotaped. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to view this videotape. The video files are digital and will be deleted after all the data are studied. At your fifth session, you will be given a CD and instructions for practicing Hatha yoga at home. While you are receiving radiation therapy, you will be asked to practice at home 1 time a day either with your caregiver or alone on the days you do not have a session at the clinic. If you are assigned to the yoga group, during each week of radiation therapy, you will also complete a questionnaire asking your feelings about the Hatha Yoga sessions. You will be asked to list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice outside of class and if you think you are benefitting from the Hatha Yoga program. It should take about 5 minutes to answer this questionnaire. Your answers to the questions will not be shared with your caregiver. Groups 1 and 2: Questionnaires: You will complete about 10 questionnaires before your first radiation treatment and again after you complete your treatment schedule (usually 6 weeks later) and then again 3 months later. The questionnaires ask about your health, any symptoms you may be having, your mood, your level of fatigue, your sleeping habits, your relationship, and your quality of life. It should take about 45 minutes to complete these questionnaires. You will also complete about 5 questionnaires again halfway through your radiation treatment schedule. These questionnaires ask about your quality of life. These should take about 20 minutes to complete. Follow-Up Phone Calls: If you are in Group 1, after you have completed the weekly yoga classes, you will receive phone calls from a study team member asking about your at home Hatha Yoga practice. You will be called every other week between the end of your radiotherapy and your final visit with the study. This will be about 5-6 phone calls and they will last approximately 10 minutes each. Saliva Testing: After your baseline visit, at the end of treatment, and 3 months after radiotherapy, you will be asked to provide saliva samples to measure the level of cortisol (a stress hormone). These saliva samples will be collected 4 times a day for 2 days in a row. You will be asked to collect the samples when you first wake up, about 45 minutes later, about 10 hours after waking, and then at bedtime. To collect each saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will write down the times at which you took these samples. You will then either either bring the samples into the clinic or mail the samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be sent to These saliva samples will be destroyed after being studied. Lung Function tests: Pulmonary Function tests (PFTs) are part of your standard treatment as a patient at MD Anderson. We will request copies of these, as available, from your electronic medical records at baseline and 3 months after radiotherapy. You will also complete the 6-minute walking test. The six-minute walk test measures the distance you are able to walk over a total of six minutes on a hard, flat surface. The goal is to walk as far as possible in six minutes. You will be allowed to self-pace and rest as needed during the walk along a marked walkway. You will complete a 6-minute walk at baseline, at the end of radiotherapy, and 3 months after radiotherapy. Length of Study: Your participation on this study will be over when you have completed the questionnaires at the time of your 3-month follow-up appointment in the thoracic clinic. This is an investigational study. Up to 50 patients and their caregivers, for a total of 100 participants, will take part in this study. All will be enrolled at MD Anderson.

This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.

Babies that are either very small or very big have increased perinatal morbidity and mortality. Predicting which babies will fall into these groups is traditionally done with risk assessment and third trimester manual palpation, however neither of these techniques are sensitive and a considerable number of affected pregnancies are missed. This results in stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third trimester can improve detection rates but this is expensive and cannot currently be provided to all NHS patients. A more sensitive test that can be performed earlier in pregnancy would allow identification of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound techniques that measure volume and volumetric flow have become available that may allow this to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant women. The findings from these scans will then be correlated with actual birth weights at the end of pregnancy to determine the ability of these parameters to act as screening tools for babies at the extremes of size.

AIMS A) Characterize unusual disease and pathologic presentations which require endoscopic treatment in a large safety net hospital B) To study the impact of EUS and ERCP on the management of these patients. C) Analyze how EUS and ERCP results correlate with other radiographic methods including conventional ultrasound and computed tomography (CT) D) Compare role of EUS and ERCP in a safety net versus tertiary care center II) BACKGROUND Endscopic Ultrasound (EUS) which consists of an endoscope containing a high frequency transducer, has become standard of care to evaluate gastrointestinal cancer as well as diseases included chronic pancreatitis. EUS with fine needle aspiration (FNA) has been demonstrated to be the least invasive and most effective means to acquire tissue in a number of situations included pancreas cancer and maligant lymph nodes. Endoscopic Retrograde Cholangiopancreatography (ERCP) is a therapeutic procedure used to manage choledocholithiasis, bile duct obstruction and occasional pancreatic ductal problems. Its diagostic uses are now more limited with the advent of EUS and cross sectional radiographic studies including CT and magnetic resonance cholangiopancreatography (MRCP). A number of leading ERCP/EUS groups including those at the University of Alabama (Birmingham, Alabama), the Cleveland Clinic (Cleveland Ohio) and the Mayo Clinic (Rochester, Minnesota) have developed ERCP/EUS databases which have led to important insight about the role of these procedure and the diseases they are used to manage. However, these groups and indeed almost the entire world literature regarding EUS and ERCP focuses on America, Western European, and Japanese populations. The goal of this database will be to study the impact of EUS and ERCP on an underserved population at LAC. The prevalence of certain diseases including cholangitis, large bile duct stones, and gastric cancer are markedly higher at our institution than in other western facilities presenting a unique opportunity to report how they are treated as part of standard management. IIIA) DESIGN AND METHODOLOGY 1. ALL PROCEDURES ARE DONE STRICTLY AS STANDARD OF CARE. 2. Detailed collection sheets containing no PHI but with detailed information about laboratories, symptoms, radiographic tests, time of presentation and procedure detals are prospectively completed for patients undergoing EUS or ERCP by the Gastroenterology service at the USC Hospitals. The resulting pathology and clinical course are collected on these anonymized forms. 3. The information in the extraction sheets is entered into a database stripped of all personal health identifiers. IIIB) PLANNED DATA COLLECTION 1. The aim of this project will be to develop a prospective database of EUS/ERCP cases at USC. 2. For both ERCP and EUS cases detailed information regarding the presentation of the patients will be noted. Specifically, which radiographic and biochemical markers and clinical symptoms are of interest. 4) For EUS the outcomes include the confirmation by biopsies and imaging of the underlying pathology. 5) For ERCP the outcomes are procedural success and more specifically bile duct stone confirmation and removal, treatment of cholangitis, treatment of leaks biliary, and decompression of obstruction. Success of anesthesia strategy is an aim of the collection. 6) For potential quality of care assessment procedure complications and success of anesthesia strategy are a priori areas of study IV) STATISTICAL CONSIDERATIONS As this study involves creation of a database of standard of care management of patients by EUS and ERCP primarily descriptive statistics will be used in future studies. If individual groups are compared (ie those with positive versus atypical fine needle aspiration) chi squared versus t statistic will be used for analysis depending on distribution..

102 patients scheduled for elective ICL/TICL implantation surgery were enrolled in this study after obtaining approval from the institutional ethical committee and written patients consent. the investigators are planning a study of matched sets of patients receiving the case and control treatments with 1 matched control(s) per experimental subject. Prior data indicate that the probability of a treatment failure among controls is 0.05 and the correlation coefficient for exposure between matched experimental and control subjects is 0.1. The true odds ratio for failure in experimental subjects relative to control subjects is 0.1, so the investigators needed to study 51 experimental subjects with 1 matched control(s) per experimental subject to be able to reject the null hypothesis that this odds ratio equals 1 with probability (power) 0.7. The Type I error probability associated with this test of this null hypothesis is 0.3. All patients were assessed and only those cooperative understanding patients who were deemed suitable for topical and DTFNBA were included in the study. Very anxious patients were omitted from the study. All the operations were done by one surgeon . Patients were prepared for bilateral implantable contact lens/toric implantable contact lens( ICL/TICL) procedure on the same day. Group I (1 eye) received topical anaesthetic drops and Group 2 (the second eye) received DTFNBA. Before giving the anaesthetics, a peripheral vein was cannulated and heart rate, oxygen saturation and non-invasive arterial blood pressure were monitored. Topical anaesthesia was done with 2% tetracaine local anaesthetic drops and DTFNBA was performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with tetracaine local anaesthetic drops. The sponges were removed after 15 minutes. The anaesthetic effect was tested by grasping the limbus with Castroviejo 0.12 tissue forceps. Pain was estimated by the patient using a simple pain score: no pain =0; that does not interfere with the surgical technique, discomfort=1; the surgical technique is performed with difficulty, pain=2; the surgeon is unable to continue the surgical technique . The scoring was done during different stages of surgery: lid retraction while inserting a speculum, tolerance to the microscope light, corneal incision, intraocular lens insertion, tucking of footplates, irrigation aspiration (I/A )of viscoelastic, peripheral iridectomy. The surgical technique was performed through a clear corneal 3.2 mm tunnel incision, followed by sodium hyalurounate injection, ICL implantation and unfolding, tucking of trailing footplates then side port incision and tucking of leading footplates, myostat injection, then peripheral iridectomy . The total operative time was recorded for every case. If the pain score was 0 or 1, no further management was required but if the pain score was 2 at any stage, 1% preservative free lidocaine was injected intracamerally. Parametric data were analyzed using Students t-test; non parametric data were compared using the Chi-square test. A P value of \<0.05 was considered statistically significant.

Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF) patients, could improve hypoxemia, maintain lung volume and promote alveolar opening. However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients with normal lung function1,2. Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance. The present study is set out to examine the effects of high chest wall elastance on changes of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary pressure(PL) stress index.

This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.