PBASE-system Acute Migraine Clinical Investigation

Summary: To evaluate the performance and safety of the PBASE-system when used in the treatment of acute migraine episodes of moderate to severe intensity. The study will evaluate the effect of treatment on migraine pain and symptoms during an acute attack and also any long-term effect.
Inclusion criteria: inclusion criteria:

 Willing and able to provide written informed consent prior to participation in the clinical investigation

 Male or female aged between 18 and 65 years

 Diagnosed as suffering from migraine with or without aura according to IHS classification (ICHD-II)

 Reported history of 2 to 6 migraine episodes per month during previous 3 months, confirmed during a prospective baseline period of one month

 Reported history of no less than 50% of migraine episodes involving moderate or severe pain intensity, confirmed during a prospective baseline period of one month

 Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during a prospective baseline period of one month

 Reported history of the majority of untreated migraine attack durations lasting 8 hours or more

 Onset of migraine headache occured before age 50

 Reported history of migraine for more than one year

 Able and willing to maintain current preventive headache medication regimen(s) (no change in type, frequency or dose) from baseline screening visit to 2 weeks post-treatment

 Able to understand and complete the electronic diary

 Experiencing an acute migraine attack of moderate to severe pain intensity at the time of treatment

 Treatment is possible within 5 hours of migraine onset

Exclusion criteria: :

 Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during a prospective baseline period of one month

 Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during a prospective baseline period of one month

 Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack

 Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visit

 Previously treated with an implantable stimulator or any implantable devices in the head and/or neck

 Diagnosed as having a pronounced anterior septal deviation

 History of sinus surgery, transphenoidal surgery for pituitary or other lesions or CSF rhinorrhea

 Fitted with a pacemaker /defibrillator

 Previously treated with radiation to the face

 Ongoing bacterial infection in the nasal cavity

 History of nose bleeds (epistaxis)

 Ongoing malignancy in the nasal cavity

 Concomitant condition that could cause excessive bleeding

 Known allergy to polyvinylchloride,the material used for fabrication of the balloon part of Catheter A100, or medicinal liquid paraffin

 Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation

 Any change in migraine prophylaxis between the screening and treatment visit

 Women of childbearing potential who is pregnant or at risk of becoming pregnant prior to or during the treatment phase

 Participation in a clinical research study within 3 months of enrolment or planned participation at any time during this clinical investigation

 Considered to meet the definition of vulnerable in the Investigator's opinion

 Headache or migraine episode within the 48 hours prior to treatment

 PRN (as required) or acute migraine medication(s) taken within the 48 hours prior to treatment


High Risk Populations Among COPD Patients in Japan

Summary: The patients with complications of COPD and asthma have features mixed with two diseases, COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating the prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary objectives are To explore the features of history of COPD exacerbations, symptoms, eosinophilic inflammation and patient background in patients with ACOS, to clarify the history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in patients with COPD. This is a cross-sectional study targeting COPD patients receiving outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and DBL would be locked by 3Q 2015.
Inclusion criteria: inclusion criteria

 Patients with a diagnosis of COPD (FEV1/FVC<0.7 confirmed based on the past medical records)

 Patients aged 40 years and over at the diagnosis of COPD

 Outpatient

 10 or more pack-years of current or former smokers

 Patients who have traceable medical records of COPD (including the results of spirometry) going back more than a year

 Patients who meet any of the following two criteria

 Patients who have medical records of the results of spirometry at more than two different time points excluding the time point of COPD exacerbations* for the past 3 years

 Patients who can provide the results of reversibility testing for respiratory tract

 Patients who give written informed consent regarding the participation in this study

Exclusion criteria:

 Patients currently with COPD exacerbations

 Patients who currently enroll in the other interventional study including clinical trials

 Patients who concurrently develop or have a history of lung cancer

 Patients who are disabled to understand the study procedure or answer the questionnaire (i.e. due to the history of alcohol or drug abuse)


PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

Summary: The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).
Inclusion criteria: inclusion criteria:

 Written informed consent

 Age > 18 years

 If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study

 Patient is willing and able to comply with the specified follow-up evaluation

 Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss)

 Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length ≤ 60 mm

 Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm

 Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session

 At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment

Exclusion criteria: :

 Acute limb ischaemia

 Subacute limb ischaemia which requires thrombolysis as first treatment modality

 Active bleeding or bleeding diathesis

 Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair

 Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment

 Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side

 Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure

 Previous implanted stent at the index site

 Life expectancy of less than 6 months or other factors making clinical follow-up difficult

 Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel

 Known allergy to contrast media

 Known heparin induced thrombocytopenia (HIT type 2)

 Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media

 Creatinine clearance < 20 ml/min (as derived from Cockcroft-Gault or MDRD formula)unless patient is on hemodialysis

 Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side

 Severely calcified lesions with expected resistance to stenting

 Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries that cannot be treated during the same session

 Significant vessel tortuosity or other parameters prohibiting access to the lesions and/or delivery of the stent

 Patients without (expected) distal runoff to the index site

 Previous implanted stent at the index site

['PTA with placement of paclitaxel-eluting stent', 'PTA']


TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)

Summary: The purpose of this study is to assess the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the immune response to a booster vaccination with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third vaccination (in Study 209).~Protocol amendment of October 2006: The study has been prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations at approximately 3 years after the third vaccination and therefore did not receive a booster vaccination at this time point. Further follow-up of TBE antibody persistence is now included for these subjects at 46 and 58 months after the third vaccination (in Study 209), as well as a booster vaccination offered at either 48 or 60 months after the third vaccination (in Study 209), depending on individual TBE antibody levels.
Inclusion criteria: inclusion criteria:

 Participated in Baxter study 209 and:

 They and/or their parents / legal guardians understand the nature of the study and agree to its provisions

 Written informed consent is available from the parents / legal guardians according to national law

 Written informed assent is available from the child/adolescent according to age and capacity of understanding

 They received the third vaccination with FSME-IMMUN 0.25 ml during the course of Baxter study 209

 Blood was drawn after their third vaccination during the course of Baxter study 209

 They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >=10 after the third vaccination in Baxter study 209

 They or their parents / legal guardians agree to keep a Subject Diary

Exclusion criteria: :

 Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml

 Have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml

 Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml

 Received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable)

 Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)

 Have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)

 Subjects will not be eligible for booster vaccination if they:

 Do not meet the inclusion /

['Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)']


Measurement of Extravascular Lung Water to Detect and Predict Primary Graft Dysfunction Following Lung Transplant

Summary: Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality following lung transplant and is characterized by acute lung injury and capillary leak leading to an increase in extravascular lung water index (ELWI) and impaired graft function. PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be life-threatening and can also lead to impaired long term lung function. In ARDS, a restrictive fluid strategy has been associated with an improvement in lung function and outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid management and limiting the extent of ELWI that accumulates in the setting of PGD are lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability index (PPI) represents a novel approach to fluid management, which has been used in patients with ARDS, but to date not in the transplant setting. To determine if these measurements may better guide the management of lung transplant patients, the investigators first wish to establish whether these methods are able to predict the onset of clinical pulmonary edema earlier, whether they correlated with traditional markers of PGD, and whether they may be useful for predicting outcomes.~AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates of pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction (PGD)~AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence and severity of PGD.~AIM 3: a) The investigators will determine whether early measurements of ELWI and PPI can predict the onset of PGD.~b) Across different strata of PGD, the investigators will determine whether ELWI and PPI have a differential effect on duration of mechanical ventilation.~The results of the study will be used for the following:~Provide the rationale for routine monitoring of ELWI to detect PGD if found to be more discriminatory and have a stronger association with outcome compared to the current gold standard.~Provide the means of early identification of those as risk of developing PGD in order to guide management decisions or future therapeutic interventions aimed at preventing or treating PGD.~Provide the requisite groundwork for a clinical trial comparing the effects of an ELWI-driven protocol versus usual care on ICU outcomes in lung transplant recipients.
Inclusion criteria: inclusion criteria:

 All consecutive bilateral lung transplant recipients

Exclusion criteria: :

 Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as the investigators would have obtained some ELWI measurements)

 Contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm)


COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis

Summary: Combination therapy of caspofungin and amphotericin B could be a useful treatment option in invasive fungal disease, but before it can be routinely recommended; carefully controlled and well-designed randomized clinical trials are needed.
Inclusion criteria: inclusion criteria:

 Adults and children > 10 years old.

 The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtain prior to the initiation of any study procedures.

 Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (≥ 20 mg Prednisone or equivalent for ≥ 3 weeks) or treatment with other immunosuppressant medications.

 Evidence of Proven or Probable Invasive Aspergillosis, by modified EORTC criteria (Appendix 2), as modified below: • Proven Invasive Aspergillosis • Histopathologic or cytopathologic examination showing hyphae consistent with the presence of aspergillus from needle aspiration or biopsy specimen with evidence of associated tissue damage (either microscopically or unequivocally by imaging); or • Positive culture result for aspergillosis from a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with infection, excluding urine and mucous membranes • Probable Invasive Aspergillosis • At least 1 host factor criterion; and • 1 microbiological criterion; and

 1 major (or 2 minor) clinical criteria from abnormal site consistent with infection; and • No other pathogens detected to account for the clinical or radiographic signs of infection

 Or (Modification of EORTC Criteria): • Patients with recent Neutropenia (absolute neutrophil count < 500 cells/mm3 within 14 days of study enrollment); and • Chest CT scan positive for Halo or Air Crescent Sign (see Section 4.2.1, Diagnostic Considerations, below) and • No other pathogens detected to account for the clinical or radiographic signs of infection

 Females of childbearing potential must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline.

Exclusion criteria: :

 Life expectancy < 30 days

 Allogenic stem cell transplant in the 6 previous months

 Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study

 Prior anti-fungal systemic therapy of ≥ 96 hours for the current, documented IA. (On the other hand, is permissible prior systemic anti-fungal therapy for prophylaxis or as empiric therapy for febrile neutropenia).

 Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug • Serum creatinine > 2x upper limit of normal (ULN)

 Serum ALT or AST > 5 x ULN

 Pregnant or lactating women

 History of allergy or serious adverse reaction to any polyene anti-fungal agent or echinochandin derivatives


Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)

Summary: PROJECT JUSTIFICATION: Cervical cancer is a serious public health problem in Brazil, and is the cause of significant morbidity and mortality among Brazilian women. In spite of government efforts to improve the coverage rates of Pap tests, the disease-related incidence and mortality rates remain high and the diagnosis is still too late.Considering that the chronic human papillomavirus (HPV) related genital infection leads to cervical cancer development, cervical cancer should be the target of primary prevention through vaccination.~PROJECT OBJECTIVES: This project aims to evaluate de following vaccination indicators: 1) Program acceptance rate; 2) Vaccine coverage rate; 3) Three-dose completion rate; 4) Rescue vaccination demand; 5) Adverse event rate;~TARGET POPULATION: Schoolgirls attending the 6th and 7th grades of elementary school (mean age = 11.9 yo).~VACCINATION PROGRAM: The program adopted the quadrivalent vaccine because it is considered superior to the bivalent vaccine in preventing HPV-induced lesions. In addition to preventing the development of pre-cancer lesions and cervical cancer, the quadrivalent vaccine has also proved to be effective in preventing condyloma, and vaginal and vulvar cancer. The girls received the vaccines doses at their schools (school-based program) and also at the Barretos Cancer Hospital.~RESULTS:~Program acceptance rate = 91.8% (95%CI: 87.0%-96.8%);~Vaccine coverage for 1st, 2nd and 3rd doses = 87.5% (95%CI: 82.9%-92.2%), 86.3% (95%CI: 81.8%-91.1%) and 85.0% (95%CI: 80.5%-89.7%).~Three dose completion rate = 97.2% (95%CI: 92.0%-100.0%). Reasons for dropping out of the vaccination program included: moving out of town (17), lost during follow up (16), guardians' decision but without a reasonable justification (3), girl refused to continue in the program (1) and pregnancy (2). Two girls interrupted the vaccination because of adverse events reported by the parents.~Rescue vaccination demand = 279 girls on the first dose (20.3%; 95%CI: 17.9%-22.8%), 357 on the second dose (26.3%; 95%CI=23.6%-29.1%) and 291 on the third dose (21.7%; 95%CI=19.3%-24.4%).~Thirty adverse events were recorded or observed in 4,074 doses, providing an adverse event rate of 0.7% (95%CI: 0.5%-1.1%). There was no severe adverse event.
Inclusion criteria: inclusion criteria:schoolgirls, attending the 6th and 7th grades of the elementary school.

Exclusion criteria: :Pregnant and breastfeeding adolescents and girls who did not attend classes.


A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin

Summary: This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
Inclusion criteria: inclusion criteria:

 Written informed consent by subject or legally authorized representative

 At least 18 years of age

 Cirrhosis and ascites

 Rapidly progressive reduction in renal function characterized by:

 Serum creatinine (SCr) ≥ 2.5 mg/dL

 Doubling of SCr within 2 weeks (or for observations of shorter duration, SCr values over time meeting slope-based criteria for proportional increases likely to be representative of at least a doubling within 2 weeks

 No sustained improvement in renal function (< 20% decrease in SCr and SCr ≥ 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin:

 Note: Albumin doses recommended by the International Ascites Club (IAC) are 1 g/kg on the first day (Maximum 100 g) and 20 - 40 g/day thereafter as clinically indicated. It is recommended (if clinically appropriate) that the albumin dose is kept constant during the study drug administration period.

 Note: The qualifying SCr value is the SCr value at least 48 hrs after both diuretic withdrawal (if applicable) and the beginning of albumin fluid challenge. The qualifying SCr value must be ≥ 2.25 mg/dL AND at least 80% of the diagnostic (pre-fluid challenge) SCr value.

Exclusion criteria: :

 SCr > 7 mg/dL

 Shock Note: Hypotension (Mean Arterial Pressure < 70 mm Hg or a decrease > 40 mm Hg in systolic blood pressure from baseline) with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation.

 Sepsis or systemic inflammatory response syndrome (SIRS)

 Note: SIRS: Presence of 2 or more of the following findings:

 Temperature > 38°C or < 36°C; heart rate > 90/min; respiratory rate of > 20/min or a PaCO2 of < 32 mm Hg; white blood cell count of > 12,000 cells/µL or < 4,000/ µL.

 Note: Sepsis: Documented infection and systemic inflammatory response syndrome.

 < 2 days anti-infective therapy for documented or suspected infection

 Proteinuria > 500 mg/day

 Hematuria or microhematuria (> 50 red blood cells per high power field)

 Clinically significant casts on urinalysis, including granular casts Note: Urine sediment examination is required to exclude presence of granular casts and other clinically significant casts [e.g., red blood cell (RBC) casts].

 Evidence of intrinsic or parenchymal renal disease (including acute tubular necrosis)

 Obstructive uropathy or other renal pathology on ultrasound or other medical imaging

 Current or recent treatment (within 4 weeks) with nephrotoxic drugs, e.g., aminoglycosides, nonsteroidal anti-inflammatory drugs (NSAID) Note: Up to 3 doses of an NSAID within the prior month (prescription or over the counter) is acceptable Note: Use of short-term (< 2 weeks) oral neomycin for acute encephalopathy is acceptable.

 Current or recent (within 4 weeks) renal replacement therapy

 Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning)

 Current or recent treatment (within 48 hours) with octreotide, midodrine, vasopressin, dopamine or other vasopressors

 Severe cardiovascular disease as judged by investigator

 Estimated life expectancy of less than 3 days

 Confirmed pregnancy

 Known allergy or sensitivity to terlipressin or another component of the study treatment

 Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization


Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)

Summary: This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.
Inclusion criteria: inclusion criteria

 Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.

 History of at least one year of infertility.

 Age between 20 and 40 years old.

 Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.

 Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.

Exclusion criteria:

 History of significant system diseases such as heart, lung, or kidney diseases.

 History of other endocrine disorders.

 Use of hormonal therapy, including metformin, in the past 3 months.

 Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.

['Letrozole', 'Chinese herbal medicine granules or Chinese herbal medicine granules placebo']


Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E

Summary: The study addresses treatment of iron deficiency, the most common nutritional deficiency that infants and young children encounter. With the knowledge that iron deficiency may irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are offering free screening blood draws at Children's Hospital Colorado to older babies and toddlers (9-24 months old). If their blood results indicate a serum ferritin of ≤ 15 micrograms/dL without the presence of an elevated C-reactive protein (CRP), they will be invited to continue in the intervention portion of the study, where they will receive iron supplements as well as vitamin E (or placebo) for an eight week treatment period. The rationale for the study is to test whether addition of Vitamin E, an antioxidant and anti-inflammatory agent, improves the treatment response to supplemental iron.
Inclusion criteria: inclusion criteria:

 Between 9-24 months of age

 Weighed 5.5 lbs or more at birth

 Born at 34 week gestation or more

Exclusion criteria: :

 Consumed infant formula within the past 3 months

 Inflammatory bowel disease, cystic fibrosis, liver or kidney disease, cancer, HIV, primary immune deficiencies, anemia unrelated to iron status, chronic blood loss in stool, inherited disorders or iron status, or bleeding or coagulation disorders)

 Previous diagnosis of iron deficiency or iron deficiency anemia

 Previous treatment of iron deficiency or iron deficiency anemia

['Iron Deficiency', 'Iron Deficiency Anemia']


Study of Oxycyte in Severe Closed Head Injury

Summary: Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. Laboratory studies in animals and clinical trials have shown that increasing oxygen in the brain results in better brain oxygen consumption, less cell death, and better functional outcome. This study will test the hypothesis that Oxycyte is an effective way to increase brain oxygen levels in severe head injury.
Inclusion criteria: inclusion criteria:

 severe closed head injury patients or GCS 3-9 patients who receive brain oxygen monitoring

 ventriculostomy/ICP monitor

 at least one reactive pupil

 no known life threatening disease prior to trauma

 age 18-70 years old

 consent for microdialysis/brain 02 monitoring

 legal family representative present that can give informed consent for perfluorocarbon administration

Exclusion criteria: :

 no motor response

 both pupils fixed and dilated

 no consent available

 allergy to egg proteins

 coagulopathy

 major liver injury

 major pulmonary injury

['perfluorocarbon emulsion (Oxycyte) infusion']


Chest Pressure for Intubated Peds Patients

Summary: 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.
Inclusion criteria: inclusion criteria:

 All pediatric patients between one and 18 year of age

 Requirement for insertion of an endotracheal tube

 American Society of Anesthesiologists (ASA) class I to III

Exclusion criteria: :

 Failure to obtain parental consent or patient assent when appropriate (in general, children over 6 years of age)

 ASA IV

 Patients with any cardiac pathology

 Patients with any respiratory pathology

 Patients with any form of chest deformity, for example, pectus excavatum, pectus carinatum, scoliosis

 Patients who had previous cardiac or thoracic surgery


Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

Summary: The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
Inclusion criteria: inclusion criteria:

 18 years or older

 Male

 signed informed Consent,

 Neg. urine multistix

Exclusion criteria: :

 Abnormalities,

 diseases or surgical procedures performed in the lower urinary-tract

['Intermittent catheter CP063CC', 'SpeediCath']

Intermittent catheter CP063CC
SpeediCath


A Neurocognitive and Immunological Study of a New Formula for Healthy Infants

Summary: 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.
Inclusion criteria: inclusion criteria:

 Full-term newborns (>37 weeks and <41 weeks gestation)

 Adequate birth weight for his gestational age (between 3-97 percentiles)

 Inclusion age: from 0 to 2 months (60 days) in the formula fed groups

 Inclusion age: 2-6 months (180 days) in the breastfeeding group

 Maximum 30 days of exclusive breastfeeding in the formula fed groups

 From 30 days on, exclusive or >70% infant formula in the formula fed groups

 Normal Apgar score: 7-10

 Umbilical pH ≥ of 7.10

 Availability to continue during the whole study period

 Informed consent signed ( parent/legal representative)

Exclusion criteria: :

 Participating in other studies.

 Nervous system disorders (hydrocephalic, perinatal hypoxia, intraventricular hemorrhage, neonatal meningitis, septic shock, West Sd...).

 Gastrointestinal disorders (cow's milk protein allergy, lactose intolerance)

 Mother's disease history or during pregnancy: neurological and metabolic diseases, diabetes mellitus type 1, hypothyroidism, undernutrition, infections TORCH complex.

 Mothers receiving anxiolytic or antidepressant treatment during pregnancy or other potentially harmful drug treatments for infants' neurodevelopment.

 Infant's family who in the investigators assessment cannot be expected to comply with the protocol.

['New infant formula', 'Standard infant formula', 'Breastfeeding']

New infant formula
Standard infant formula
Breastfeeding


The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS

Summary: To find oral doses of FIAC (a pyrimidine nucleoside analog) that are effective in treating cytomegalovirus (CMV) viremia in HIV-infected immunocompromised patients; to determine tolerance and safety of FIAC in this patient population; and to determine pharmacokinetics following multiple doses of FIAC. (An example of another nucleoside analog effective against retroviruses such as HIV is zidovudine (AZT).) CMV infection is a medically significant opportunistic disease in patients with HIV-related infection. The purine nucleoside ganciclovir has been used to treat AIDS patients with CMV disease. Although ganciclovir is useful in treating CMV disease, such treatment is frequently complicated by hematologic (blood) toxicity. Also, treatment is difficult because it requires daily intravenous dosing. Test tube studies show that FIAC and its primary breakdown product FIAU are highly and specifically active against several viruses including CMV. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU.
Inclusion criteria: inclusion criteria

 Concurrent Medication:

 Allowed:

 Pentamidine aerosol for prophylaxis of recurrent Pneumocystis carinii pneumonia (PCP) in patients currently receiving such treatment.

 Prior Medication:

 Allowed:

 Zidovudine (AZT) but only if patient has been taking the drug for > 6 weeks at a dose = or < 600 mg/day, and had < 10 percent decrease in hematocrit, neutrophils, and platelets in the last 30 days. Those off AZT must have been off it for > 1 month.

 Patients must:

 Have documented cytomegalovirus (CMV) viremia or viruria.

 Have a diagnosis of HIV infection by ELISA or Western blot.

 Be able to participate as an outpatient.

 Be ambulatory.

 Grade 0 or 1 AIDS Clinical Trial Group toxicity grades for specified laboratory tests.

 Be competent to sign informed consent.

 Be able to cooperate with the treatment plan and evaluation schedule.

 NOTE:

 The screening tests must be initiated and completed within 4 weeks prior to the first dose of FIAC.

 Concomitant diseases allowed:

 Stable mucocutaneous Kaposi's sarcoma.

 Superficial or uncomplicated infections such as thrush.

Exclusion criteria:

 Co-existing Condition:

 Patients with the following are excluded:

 HIV wasting syndrome (involuntary weight loss > 10 percent of baseline body weight and/or chronic diarrhea or weakness and documented fever for at least 30 days).

 Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis.

 Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition.

 Cytomegalovirus end organ disease.

 Kaposi's sarcoma requiring chemotherapy.

 Systemic fungal infection requiring amphotericin therapy.

 Diagnosis of idiopathic thrombocytopenic purpura (persistent platelet counts < 100000 platelets/mm3 for = or > 3 months).

 Patients with the following are excluded:

 HIV wasting syndrome.

 Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis.

 Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition.

 Cytomegalovirus (CMV) end organ disease e.g., retinitis, hepatitis, gastroenteritis.

 Prior Medication:

 Excluded within 4 weeks of study entry:

 Zidovudine (AZT).

 Acyclovir.

 Ganciclovir (DHPG).

 Foscarnet.

 Interferon.

 Other drug with putative anticytomegaloviral activity.

 Any immunostimulating drug not specifically allowed.

['Cytomegalovirus Infections', 'HIV Infections']

Cytomegalovirus Infections
HIV Infections


Tranexamic Acid in Chronic Subdural Hematomas

Summary: BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial neurosurgical consult. There is no widely accepted medical treatment for CSDH.~This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH resolution following conservative management, lower the number of required surgical procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to provide preliminary efficacy data as well as feasibility, safety and incidence data required to plan a larger definitive phase III trial.~METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component will be screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be randomized to receive either 750 mg of TXA daily or placebo until complete radiological resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial CT scanning. Cognitive function tests, quality of life questionnaires as well as functional autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months post-treatment follow-up. During the treatment period, patients will undergo standard CSDH management with surgery being performed at the discretion of the treating physician. If surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis.~The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life, incidence of complications and length of hospital stay. Planned subgroup analyses will be performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised CSDH.~DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment has yet to be discovered. The TRACS trial will be the first prospective study of TXA for CSDH.
Inclusion criteria: inclusion criteria:

 CT scan demonstrating the existence of a subdural hematoma containing a chronic component

 Diagnosis within the last 14 days

Exclusion criteria: :

 Acute subdural hematoma with no chronic component;

 Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year;

 Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism;

 Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency;

 Atrial fibrillation (unless under successful rhythm control therapy);

 Metallic heart valve;

 Vascular stenting procedure within the last year;

 Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty;

 Ongoing investigation for suspected malignancy;

 Confirmed active malignancy;

 Concomitant hormone therapy for malignancy;

 Concomitant hormone contraceptive pill;

 Macroscopic hematuria;

 Known or suspected tranexamic acid allergy;

 Pregnancy or breastfeeding;

 Concomitant use of anticoagulant medication;

 Any concern from the attending physician.


Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores

Summary: Patients candidates for total hip replacement are, generally elderlies and have hip pain, we will check if the pressure to the soft tissue changes before and after operation using a tapet with pressure sensors sending the information to specific software.
Inclusion criteria: inclusion criteria: 60 y/o/ and more

 Both sexes

 Schedule for total hip replacement

Exclusion criteria: :

 Patient with previous bedsore

 Patients under 60 y.0.

 Previous CVA


Influence of Tidal Volume During Mechanical Ventilation on Postoperative Clinical Outcome in Pediatric Patients Undergoing Congenital Heart Surgery

Summary: High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.
Inclusion criteria: inclusion criteria:

 pediatric patients who underwent surgery for congenital heart disease with cardiopulmonary bypass between 2009 and 2013 in Samsung Medical Center

Exclusion criteria: :

 patients who lack data regarding mortality, creatinine, estimated glomerular filtration rate, or urine output.

['Surgery for congenital heart disease']

['Patients Who Underwent Surgery for Congenital Heart Disease']


Teenage Driving Safety Study: An Emergency Medicine-Trauma Collaborative Study

Summary: Teenage driving safety continues to be a major public health issue. Two factors have been found to contribute to a higher teenage driving accident rate than adults: lack of driving experience, and risky behaviors. Insufficient driving experience puts teenagers at a disadvantage in detecting and responding to hazards while driving. Factors contributing to distracted driving (a diversion in the driver's attention from the road) may include: talking or text messaging on a cell phone, applying makeup, having multiple passengers, listening to loud music, eating/drinking, smoking or reading while driving.~This is a prospective study designed to evaluate the effect of an educational program on the risks associated with distracted driving for teenage drivers. The researchers will compare cell phone usage behaviors in Pennsylvania, where no cell phone laws are in place, and New Jersey, where cell phone laws exist, and will educate the beginner driver on the potential dangers associated with driving without a seat belt, substance use, and participating in distracting driving behaviors. Knowledge of state laws will also be assessed.~Objectives~Educate participants on the potential dangers of distracted driving.~Evaluate the impact of the educational program on teenage distracted driving behaviors by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education.~Quantify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education.~Qualify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, anonymous observation, and anonymous voicemails, text messages, and/or emails pre, post, and delayed post education.~Qualify distracted driving behavior in adults through anonymous observations near local area high schools.~6. Compare teenage driving behaviors as reported and observed between Pennsylvania and New Jersey.~7. Compare seat belt usage, driving behaviors, and substance use in the study population to the state and national averages pre and post education.~8. Compare averages of student's knowledge of state driving laws pre and post education.
Inclusion criteria: inclusion criteria:

 Teenagers perceived to be students driving near school property.

 Teenagers perceived to be of driving age.

 Teens in 10th, 11th, and 12th grades attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools.

 Any driver driving near school property, which is perceived to be older than of high school age.

Exclusion criteria: :

 Teenagers perceived as non-attendees of the nearby school.

 Teenagers perceived not to be of driving age.

 Teens not in 10th, 11th, and 12th grades, or not attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools.

 Any driver who does not meet the above criteria.

 -


The First Therapeutic Intervention in Malignant Pleural Effusion Trial

Summary: Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this.~The investigators hope to find the best way to prevent pain during pleurodesis.
Inclusion criteria: inclusion criteria:

 Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of:

 Histologically proven pleural malignancy OR

 Typical features of pleural malignancy seen on direct vision during thoracoscopy OR

 Pleural effusion in the context of histologically proven cancer elsewhere

 Expected survival more than 1 month

 Written informed consent

Exclusion criteria: :

 Age < 18 years

 Primary lymphoma or small cell lung carcinoma

 Patients who are pregnant or lactating

 Inability to give informed consent

 History of GI bleeding or of untreated peptic ulceration

 Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen

 Hypercapnic respiratory failure

 Known intravenous drug abuse

 Severe renal or liver disease

 Known bleeding diathesis

 Warfarin therapy

 Current or recent (within 2 weeks) corticosteroid steroid therapy

['Large bore chest drain + NSAID based analgesic regimen', 'Small bore chest drain + NSAID based analgesic regimen', 'Large bore chest drain + opiate based analgesic regimen', 'Small bore chest drain + opiate based analgesic regimen']

['Malignant Pleural Effusion', 'Pleural Effusion']

Malignant Pleural Effusion
Pleural Effusion


Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb

Summary: Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. The limits of peripheral artery disease (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. By stimulating these processes the investigators might be able to provide an alternative treatment strategy for patients with lower limb ischemia. In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (EPC) from preexisting vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in patients with limb ischemia. So the investigators determine to evaluate the efficacy of repeated MNC transplantation in patients with ischemic lower limb.
Inclusion criteria: inclusion criteria:

 Ischemic lower limb based on TASK guide line

 Rutherford score:2,3

 ABI<0.6

 Absolute ankle pressure < 60 mmHg

 Both gender

 Age:20-62years

Exclusion criteria: :

 EF<30%

 Cr>2

 HbA1c>8%

 Bone marrow disorders:leukemia

 Cognitive disorders

 Infections

 MI with ST elevation during last month

 Malignancy

 Immunologic or rheumatologic disorders

['4times injection', 'stem cell transplantation']

4times injection
stem cell transplantation


Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.

Summary: The aim of this study is to determine the prevalence of pneumococcal meningitis in the paediatric population in Spain four years after the marketing of Prevenar. Also secondary objectives are: 1) to determine the clinical characteristics and outcome of the disease; and 2) to determine serotypes and antibiotic resistance patterns.
Inclusion criteria: inclusion criteria:

 All children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study.
Exclusion criteria:


Efferocytosis and Genomic Polymorphism in Autoimmune Diseases

Summary: Over the past few years, growing evidences revealed that clearance of apoptotic cells by phagocytosis can result in powerful anti-inflammatory and immunosuppressive effects. In vivo, apoptotic cells are cleared rapidly by neighboring cells, macrophages and related scavengers. Defective clearance of apoptotic cells has been linked closely to autoimmunity and persistent inflammatory disease. Several phagocytic receptors, bridging molecules produced by phagocytes and 'eat-me' signals on apoptotic cells are coordinately involved in mediating clearance of apoptotic cells. Complement receptors (CR3, CR4), collection, CD14, CD36 (Class B scavenger receptor), class A scavenger receptor, asialoprotein receptor, Mer receptor kinase were reported to recognize apoptotic cells. The best characterized system for clearance of apoptotic cells is the recognition of phosphatidylserine (PS) on apoptotic cells by phosphatidylserine receptor (PSR). Milk fat globule- epidermal growth factor 8 (MFG-E8) is an opsonin that bridges phagocytes (by interacting with α vβ3, αvβ5 integrins via RGD motif) and apoptotic cells (by binding PS through Factor V/VIII-C domain). Activated macrophages produce and secret MFG-E8. MFG-E8 is a critical component in PSR-mediated phagocytosis of apoptotic cells. The dominant negative mutant MFG-E8, D89E, that carried a mutated RGD motif inhibited phagocytosis of apoptotic cells in vitro. Injection of D89E into wild type mice induced autoantibodies and IgG deposition on glomeruli. Macrophages from MFG-E8 deficiency (MFG-E8-/-) mice were impaired in engulfment of apoptotic cells, which can be restored by adding recombinant MFG-E8. The female MFG-E8-/- mice spontaneously produced high titer of autoantibodies and developed lupus-like glomerulonephritis at the age of week 40. Defective clearance of apoptotic cells is closely related to development of autoimmunity. In the past 4 years, a growing number of molecules were recognized as receptors for the PS exposed on the apoptotic cells. These molecules were capable of mediating phagocytic clearance, rendering anti-inflammatory cytokines in the phagocytes, and modulating T cell responses.~The specific aim of this proposal is to study genetic polymorphism in MFG-E8, PSR and other factors implicated in phagocytic clearance of apoptotic cells among Taiwanese. By comparing the polymorphism between patients with autoimmune disease (SLE or RA) and healthy control subjects, we will investigate if genetic variations among individuals of genes encoding proteins involved in clearance of apoptotic cells contribute to the pathogenesis of systemic autoimmune diseases SLE and RA.
Inclusion criteria: inclusion criteria:

 SLE, RA, healthy

Exclusion criteria: :

 nil

['SLE', 'Rheumatoid Arthritis', 'Healthy Subjects']

SLE
Rheumatoid Arthritis
Healthy Subjects


Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke.

Summary: The purpose of this study is to improve secondary prevention of ischemic stroke patients by~Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation.~Characterize ischemic stroke patients by~Echocardiographic characteristics~Biochemical markers~Plaque composition in the carotid arteries~in order to improve risk stratification.
Inclusion criteria: inclusion criteria:

 admitted with ischemic stroke at a single center

 time from diagnose to inclusion maximum 7 days.

 written informed consent or surrogate informed consent eligible

 age > 18 years.

Exclusion criteria: :

 hemorrhagic stroke

 terminal illness and expected lifespan of less than 6 months.

 any physical or mental condition which make the patients unsuitable for participation in the study.

 known with a pacemaker

 anticoagulation treatment of other reasons than atrial fibrillation.

['Stroke', 'Atrial Fibrillation', 'Premature Atrial Complexes']

Stroke
Atrial Fibrillation
Premature Atrial Complexes


Effect of Childhood Radioiodine Therapy on Salivary Function

Summary: Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.
Inclusion criteria: inclusion criteria:

 Patients who have been treated with radioiodine therapy

 Patients who have never received radioiodine therapy (negative control group)

Exclusion criteria: :

 Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way.

['Xerostomia', 'Hyperthyroidism', 'Thyroid Cancer']

Xerostomia
Hyperthyroidism
Thyroid Cancer


RESynchronizaTiOn theRapy and bEta-blocker Titration

Summary: Patients will be treated according to the clinical practice of the participating centers and to the international guidelines for the treatment of heart failure.The present analysis provides a collection of data about the changes to drug therapy after the Cardiac Resynchronization Therapy (CRT) procedure , and any signs and symptoms of intolerance to prescribed medications.
Inclusion criteria: inclusion criteria:

 Patients on optimal therapy for heart failure (diuretics, ACE inhibitors and aldosterone antagonists), with stable dose in the previous month;

 Successfully implanted with CRT-D according to current European Society of Cardiology (ESC) guidelines;

 New York Heart Association (NYHA) functional class: II, III and IV;

 Left Ventricular Ejection Fraction (LVEF) ≤ 35%;

 Duration of ventricular depolarization wave (QRS) ≥ 120ms (NYHA III or IV) or ≥ 150ms in NYHA II;

 Patients with chronic atrial fibrillation will be eligible for the study only if they undergo ablation ;

 18 years or above

Exclusion criteria: :

 Failure to comply with the scheduled follow-up;

 Life expectancy less than 12 months ;

 Pregnant women;

 Tricuspid valve mechanics;

 Severe aortic stenosis or other valve disease ;

 Patients already receiving CRT.

['Beta Blocker Intolerance', 'Congestive Heart Failure']

Beta Blocker Intolerance
Congestive Heart Failure


Sharp Versus Blunt Fascial Incision at Caesarean Section

Summary: The purpose of this study is to compare sharp and blunt fascial entry during caesarean section on the same patient. The study is performed on woman having cesarean section for the first time and who have not previously had lower abdominal surgery done. The following parameters are registered:~The preferred side evaluated by the patient 3 months postoperatively.~The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and 1 and 3 months postoperatively.~The rate and side of infection.
Inclusion criteria: inclusion criteria:

 Woman having caesarean section for the first time

 Woman, who have had no previous lower abdominal surgery

 Woman who speak and understand Danish

 Woman who can give informed consent

Exclusion criteria: :

 Diabetes Mellitus (This does not include gestational diabetes)

 Infection

 Regular treatment with immunosuppressives

 Alcohol or drug abuse

 Age under 18 years old

 Chronic pain disease eg. fibromyalgia, rheumatoid arthritis

 BMI over 35

['Blunt right, sharp left', 'Blunt left, sharp right']

Blunt right
sharp left
Blunt left
sharp right


The Use of a Forecasting System for Predicting Exacerbations of COPD

Summary: People with Chronic Obstructive Pulmonary Disease (COPD) often have periods during the year when their symptoms become worse. These are often due to an infection and are called exacerbations by doctors. Exacerbations are more common in the winter and also seem to be related to particular types of weather. As well as forecasting the weather the UK Met Office has developed a system to try to predict when exacerbations are likely to occur. The main purpose of this research study is to find out whether the Met Office forecasting service can predict when exacerbations are more likely to occur and whether the advice given during the predicted higher risk periods leads to fewer patients having an exacerbation or if it reduces the impact of the exacerbation. The study will also assess if there is a link between viral or bacterial infection and breathing problems that occur during the study period. The study will also collect information about possible causes of the breathing problems and what happens to the person afterwards. The results of this study will help us learn more about breathing problems which may lead to new research studies that would aim to improve the care of people with COPD.
Inclusion criteria: inclusion criteria:

 Current or former smokers with a diagnosis of COPD

 Having impaired lung function as measured by spirometry

Exclusion criteria: :

 History of asthma or nasal symptoms caused by hayfever

 No telephone

 Inability to record symptoms in an electronic diary (PDA)

['COPD self care advice', 'Poor weather forecast warning']

COPD self care advice
Poor weather forecast warning

['Chronic Obstructive Pulmonary Disease (COPD)']


Standard Therapy With or Without Dalteparin in Treating Patients With Advanced Breast, Lung, Colorectal, or Prostate Cancer

Summary: RATIONALE: Dalteparin may be effective in inhibiting the growth of blood vessels in tumors, decreasing the risk of metastatic cancer, preventing the formation of blood clots, and improving quality of life in treating patients with advanced cancer that has not responded to previous treatment. It is not yet known if standard therapy is more effective with or without dalteparin in treating advanced breast, lung, colorectal, and prostate cancer.~PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of standard therapy with or without dalteparin in treating patients who have advanced breast, lung, colorectal, or prostate cancer that has not responded to previous chemotherapy or hormone therapy.
Inclusion criteria: DISEASE CHARACTERISTICS: Histologically or cytologically proven breast, lung, colorectal, or prostate cancer that has failed prior chemotherapy or hormone therapy No active CNS metastases Hormone receptor status: Not specified

 PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3500/mm3 Platelet count at least 150,000/mm3 Fibrinogen above lower limits of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Prothrombin time no greater than 1.5 times ULN Active partial thromboplastin time no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No history of heparin associated thrombocytopenia At least 1 year since prior thromboembolic phenomenon such as deep venous thrombosis, pulmonary embolus, or clotted catheter No prior intolerance of unfractionated or low molecular weight heparin

 PRIOR CONCURRENT THERAPY: No concurrent anticoagulation therapy No concurrent enrollment on systemic or radiation therapy study (therapy off study allowed)
Exclusion criteria:

['Breast Cancer', 'Colorectal Cancer', 'Lung Cancer', 'Prostate Cancer', 'Veno-occlusive Disease']

Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Veno-occlusive Disease


Single Incision Versus Standard Laparoscopic Splenectomy

Summary: This is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy.~The hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. However, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.
Inclusion criteria: inclusion criteria:

 Need for splenectomy

Exclusion criteria: :

 Splenomegaly

['Single Incision Splenectomy', 'Laparoscopic Splenectomy']

Single Incision Splenectomy
Laparoscopic Splenectomy

['Hereditary Spherocytosis', 'Idiopathic Thrombocytopenic Purpura']

Hereditary Spherocytosis
Idiopathic Thrombocytopenic Purpura


12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients. Correlation to Dyspnoea Scales

Summary: Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function and static lung volumes, correlate this effect with dyspnoea in COPD patients.
Inclusion criteria: inclusion criteria:

 Male or female patients 40 years of age or older.

 All patients had to have a diagnosis of COPD and had to meet the following spirometric and static lung volume criteria:

 Patients had to have relatively stable, moderate to severe airway obstruction with:

 FEV1 ≤ 50 % of predicted value,

 FEV1/SVC ≤ 70 %.

 All patients had to have the presence of lung hyperinflation as demonstrated by RV ≥ 125 % of predicted value.

 Predicted normal values were calculated according to European Community Coal and Steel (ECCS)

 Males:

 FEV1 predicted (L) = 4.30 x height (metres) - 0.029 x age (years) - 2.49

 RV predicted (L) = 1.31 x height (metres) + 0.022 x age (years) - 1.23

 Females:

 FEV1 predicted (L) = 3.95 x height (metres) - 0.025 x age (years) - 2.60

 RV predicted (L) = 1.81 x height (metres) - 0.016 x age (years) - 2.00

 Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (p.y.). Patients who never smoked cigarettes were excluded.

 Number of p.y. = Number of cigarettes/day / 20 x years of smoking

 Patients had to be able to perform all study related tests including the SWT, acceptable pulmonary function tests including PEFR measurements, and had to be able to maintain records during the study period as required in the protocol.

 Patients had to be able to inhale medication from the HandiHaler.

 All patients had to sign an informed consent form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medication.

 Eosinophilia < 600/mm³ documented in the past year (if not available, a blood count cell was performed).

Exclusion criteria: :

 Patients with a history of asthma, allergic rhinitis or atopy.

 Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator may have either put the patient at risk because of participation in the study or a disease which may have influenced the results of the study or the patient's ability to participate in the study.

 Patients with a recent history (i.e. one year or less) of myocardial infarction.

 Patients with a recent history (i.e. three years or less) of heart failure, pulmonary oedema, or patients with cardiac arrhythmia requiring drug therapy.

 Patients who regularly used daytime oxygen therapy for more than one hour per day and in the investigator.s opinion was unable to abstain from the use of oxygen therapy.

 Patients with known active tuberculosis.

 Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.

 Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.

 Patients who underwent thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason were evaluated as per exclusion criterion No. 2.

 Patients with lower respiratory tract infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.

 Patients who were currently in a pulmonary rehabilitation programme or who completed a pulmonary rehabilitation programme in the six weeks prior to the Screening Visit (Visit 1).

 Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.

 Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.

 Patients with known narrow-angle glaucoma.

 Patients who were treated with β-blockers, cromolyn sodium or nedocromil.

 Patients who were treated with antihistamines (H1 receptor antagonists) or antileukotrienes.

 Patients who were treated with monoamine oxidase inhibitors or tricyclic antidepressants.

 Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.

 Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intra-uterine devices, diaphragm or subdermal implants).

 Patients with history and/or active significant alcohol or drug abuse.

 Patients who took another investigational drug within one month or ten half lives (whichever was greater) prior to Visit 1.

['Tiotropium inhalation capsules', 'Placebo inhalation capsules']

Tiotropium inhalation capsules
Placebo inhalation capsules

['Pulmonary Disease, Chronic Obstructive']


Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale

Summary: Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/- transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind of control is not systematically performed. In order to improve the clinical outcomes in this young patients' population, the investigators prospectively perform a complete cardiologic and neurologic follow-up program to all patients undergoing a successful percutaneous closure of a PFO.~The aim of these controls is to confirm the good position of the PFO-device, to confirm the absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a residual shunt, size of the utilized closure device, ....).
Inclusion criteria: inclusion criteria:

 18 years old patients

 signed informed consent

 all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke

Exclusion criteria: :

 all patients with an alternative aetiology of the initial stroke

 all patients in whom the percutaneous closure of the PFO is contraindicated

 all patients with a known allergy to aspirin and or clopidogrel


Effects of Drainage in Laparoscopic Cholecystectomy

Summary: During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.
Inclusion criteria: inclusion criteria:

 acutely inflamed gallbladder

Exclusion criteria: :

 chronic cholecystitis

 gallbladder polyp or gallbladder cancer

 the patient who underwent reduced port surgery

 the patient who underwent common bile duct exploration during the operation

 the patient who underwent concurrent operation

 the patient who had past history of upper abdominal surgery

 the patient who had a immunodeficiency state

 the case which had a suspicion of delayed bile leakage

 the case which had a incomplete cystic duct ligation

 the patient who underwent open conversion surgery during the operation

 the patient who had a high risk of bleeding

['Laparoscopic cholecystectomy with drain insertion']

['Empyema of Gallbladder', 'Abscess of Gallbladder', 'Acute Cholecystitis']

Empyema of Gallbladder
Abscess of Gallbladder
Acute Cholecystitis


A Study Into the Effect of Seprafilm in Open Total Thyroidectomy

Summary: The investigators intend to determine the role of Seprafilm, a popular anti-adhesive agent in minimising internal adhesion formation in the neck after thyroid surgery and therefore reduce swallowing discomfort experienced by patients after surgery.
Inclusion criteria: inclusion criteria:

 Age 21-75

 Histological confirmation of differentiated thyroid cancer requiring surgery, symptomatic goiters, thyroid nodules requiring histological analysis, or thyrotoxicosis poorly controlled by medication.

 Undergoing total thyroidectomy

Exclusion criteria: :

 Previous neck surgery

 Previous neck radiotherapy

 Patients with a known history of keloids

 Patients with a known history of motility disorders in the upper gastrointestinal tract and preexisting swallowing difficulty.

 Patients with metastatic disease; patients with disease that would require postop radiation therapy, radionuclide iodine therapy and any adjuvant therapies.

 Patients with advanced disease that would require radical or modified neck dissection

 Patients with lobe larger than 10 cm, or nodule larger than 8 cm which require extensive dissection that may confound the study

 Patients with connective tissue diseases and chronic diseases on long-term medications that may interfere with wound healings such as steroids


Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

Summary: In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators will collect real world data on their short and long term outcomes. The investigators hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2. there will be less bleeding than when patients are on conventional anticoagulants; 3. there will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary hypertension and post-thrombotic limb syndrome.
Inclusion criteria: inclusion criteria:

 Patients aged 18 years or older with an objectively verified diagnosis of DVT and/or PE and treated according to routine clinical practice with Rivaroxaban

Exclusion criteria: :

 Patients in whom follow-up is unlikely or impossible

 Patients unable to give consent

 Patients who receive heparin therapy for more than 48 hours

 Patients who receive more than one dose of warfarin

 Patients with an indication for anticoagulation other than DVT and/or PE

 All contraindications listed in the local product information (SmPC) will form part of the


Prevention of Pregnancy-associated Malaria in HIV-infected Women: Cotrimoxazole Prophylaxis Versus Mefloquine

Summary: The purpose of this study is to evaluate the efficacy of cotrimoxazole prophylaxis in prevention of malaria during pregnancy in HIV-infected women, compared to intermittent preventive treatment with mefloquine.
Inclusion criteria: inclusion criteria:

 Confirmed HIV seropositivity

 Permanent residency in the study catchment's area

 Confirmed pregnancy, gestational age< 28 weeks

 More than 18 years of age

 Karnofsky index ≥80

 Willingness to deliver at the hospital

 Written informed consent

Exclusion criteria: :

 History of allergy to study drugs : sulpha drugs, mefloquine, quinine

 History or presence of major illnesses : severe renal disease , severe hepatic disease, severe neuropsychiatric disease

 Mefloquine or halofantrine received within the 4 weeks prior to enrolment

['Malaria in Pregnancy', 'HIV Infections']


A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers

Summary: The goal of this study is to see if giving patients information about how smoking affects oral health will help them quit smoking. What we learn from this study will help researchers find new ways to help smokers.
Inclusion criteria: inclusion criteria:

 Patient seeking routine dental care at NYU College of Dentistry and meets medical clearance for routine care

 Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day)

 Able to provide a telephone number or collateral contact information where they can be reached over the subsequent 12 months

 Fluent in English or Spanish

Exclusion criteria: :

 History of mouth or throat cancer

['Standard Care only', 'Dental Hygienist provided counseling + Brief Questionnaire', 'Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire']


The EARN-Health Trial of Financial Savings and Health

Summary: The current literature in social epidemiology and public health suggests that low financial savings has an unsurprising negative relationship with subjective well-being, and increases the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis, and experiencing medical disability. Earn.org is a community-based non-profit based in San Francisco with a mission to help low-income workers build lifelong savings habits and financial capability. The organization is one of the largest providers of goal-based savings accounts or matched savings accounts in the US. The investigators propose to conduct a randomized controlled trial to determine the health effects of Earn's savings program. Through this trial, the investigators will test three principal hypotheses: (1) Participants in the Earn account, as compared to a control group, are hypothesized to demonstrate improved scores on mental health scales assessing depression and anxiety.~(2) Participants in the Earn account, as compared to a control group, are hypothesized to experience lower odds of harmful behaviors associated with stress, specifically tobacco and alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller effect size, and more delayed, than the effect on mental health outcomes, judging from similar effects observed in the micro-credit literature.~(3) The mediating variables between Earn account participation and beneficial health outcomes will include increased optimism and internal locus of control.
Inclusion criteria: inclusion criteria:

 English-speaking US residents

 ages 18 and older

 below 50% of the area median income

 have a regular Internet connection

Exclusion criteria: :

 non-English speakers

 non-US residents

 children,

 history of or current enrollment in other incentivized savings programs

['Depression', 'Anxiety', 'Alcohol Abuse', 'Tobacco Abuse']

Depression
Anxiety
Alcohol Abuse
Tobacco Abuse


Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.~PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.
Inclusion criteria: DISEASE CHARACTERISTICS: Diagnosis of peripheral primitive neuroectodermal tumor, including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms

 PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

 PRIOR CONCURRENT THERAPY: Not specified
Exclusion criteria:

['cyclophosphamide', 'doxorubicin hydrochloride', 'etoposide', 'ifosfamide', 'vincristine sulfate', 'conventional surgery', 'radiation therapy']

cyclophosphamide
doxorubicin hydrochloride
etoposide
ifosfamide
vincristine sulfate
conventional surgery
radiation therapy


Long-term Oxygen Treatment Trial

Summary: Chronic obstructive pulmonary disease (COPD) is a serious respiratory disease in which the airways in the lungs are partially blocked, resulting in symptoms of chest tightness, coughing, and difficulty breathing. Currently, there are many available treatments for managing COPD symptoms and improving quality of life, including medications, lifestyle changes, oxygen therapy, and pulmonary rehabilitation. For people with severe COPD that is characterized by very low blood oxygen levels at rest, long term oxygen therapy can help to prolong life and promote feelings of well-being. However, the effectiveness of supplemental oxygen therapy for people with COPD that is characterized by only moderately low blood oxygen levels at rest or normal blood oxygen at rest and desaturation on exercise is not known. This study will evaluate the effectiveness of supplemental oxygen therapy in treating people with COPD who have moderately low blood oxygen levels at rest or who have normal blood oxygen levels at rest, but have low or very low blood oxygen levels during exercise.
Inclusion criteria: inclusion criteria:

 Age at least 40 years

 COPD

 Dyspnea, determined by Modified Medical Research Council (MMRC) scale of at least 1

 Dyspnea and lung disease process dominated by COPD in judgment of the study physician

 Participant must meet one of the following:

 Post-bronchodilator forced expiratory volume in 1 second (FEV1) percent less than or equal to 70% predicted

 Post-bronchodilator forced expiratory volume in 1 second (FEV1) percent >70% predicted and LOTT study physician determines that there is radiologic evidence of emphysema

 Post-bronchodilator FEV1/forced vital capacity (FVC) less then 0.70

 Participant must meet either of the following oxygen saturation criteria:

 Oxygen saturation of at least 89% and no greater than 93% after sitting quietly on room air, without hyperventilation and without pursed lips breathing during oximetry

 Resting oxygen saturation 94% or greater and desaturation during exercise defined as saturation below 90% for at least 10 seconds during the 6 minute walk test

 If participant is on supplemental oxygen at the start of screening, all of the following must be met prior to randomization:

 Participant agrees to stop using oxygen if randomized to no oxygen

 Participant's physician agrees in writing to rescind order for oxygen if participant is randomized to no oxygen

 Participant must report not using oxygen on the day of randomization and must report not using oxygen for the 4 calendar days prior to randomization

 Satisfactory resolution of logistics of continuation with same oxygen company with waiver of cost sharing obligations or switch to new company that will waive cost sharing obligations if participant is randomized to oxygen

 At least 10 pack-years of tobacco cigarette smoking before study entry

 Agreement not to smoke while using supplemental oxygen

 Medicare beneficiary with both Part A and Part B coverage or insurance OR personally willing to cover costs typically covered by Medicare

 Approval of study physician for randomization to either treatment group

 Completion of all required prerandomization assessments within 60 days of initiating study entry

 Randomization within 60 days of initiating eligibility evaluation

 Consent

Exclusion criteria: :

 Less than 30 days post treatment for acute exacerbation of COPD as of initiating eligibility evaluation (less than 30 days from last dose of antibiotics or since a new or increased dose of systemic corticosteroids was initiated); chronic use of systemic corticosteroids while health is stable is not exclusionary

 COPD exacerbation requiring antibiotics, new or increased dose of systemic corticosteroids, or oxygen treatment after screening starts and prior to randomization (chronic use of corticosteroids while health is stable is not exclusionary)

 Less than 30 days post discharge from an acute care hospital after acute care hospitalization for COPD or other condition, as of initiating eligibility evaluation (participant may be in a rehab hospital at time of screening)

 New prescription of supplemental oxygen after screening starts and before randomization

 Thoracotomy, sternotomy, major cardiopulmonary intervention (e.g., lung resection, open heart surgery, etc.), or other procedure in the 6 months before study entry likely to cause instability of pulmonary status

 Non-COPD lung disease that affects oxygenation or survival

 Epworth Sleepiness Scale score greater than 15

 Desaturation below 80% for at least 1 minute during the 6-minute walk test

 Disease or condition expected to cause death, inability to perform procedures for the trial, or inability to comply with therapy within 6 months of random assignment, as judged by the study physician

 Participation in another intervention study

['Chronic Obstructive Pulmonary Disease']


Evaluating the Clinical Efficacy and Safety of Colflex

Summary: This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.
Inclusion criteria: inclusion criteria:

 availability to give written consent

 age 18-60, men and women (who are not pregnant or nursing)

 people in good health

 able to follow protocol

 must be experiencing a sore throat or cold at least once a year

Exclusion criteria: :

 smokers

 liver and kidney disease

 inflammatory bowel disease

 pancreatitis

 gallbladder or biliary disease

 neurolgical/psychological disease

 bleeding disorders

 platelet abnormatilies

 gastrointestinal disorders that could interfere with fat absorption

 serum triglycerides > 500 mg/dL and/or total cholesterol > 300 mg/dL

 hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 Hg

 BMI >30

 consume or planned to consume anticoagulant, hypertension, or lipid lowering medications

 reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence

 reported use of experimental medication within 1 month prior to the trial


A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

Summary: This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.
Inclusion criteria: inclusion criteria:

 Age between 18 years and 90 years old

 Clinically significant functional mitral regurgitation (moderate-to-severe or severe mitral regurgitation), as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory

 Assessed by the investigator to be on optimal standard of care therapy for heart failure for at least 4 weeks with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization

 Documented New York Heart Association Class III or Class IV heart failure, despite optimal standard of care therapy, within 90 days preceding randomization

 Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of at least 350 pg/mL for BNP or at least 1400 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization

 Left ventricular ejection fraction (LVEF) ≥15% and ≤40% determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory

 Left ventricular end diastolic diameter (LVEDD) ≥55 mm determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory

 Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness

 Subject agrees to return for all required post-procedure follow-up visits

 The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee

Exclusion criteria: :

 Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative mitral regurgitation), as determined by transesophageal echocardiography

 Status 1 heart transplant or prior orthotopic heart transplantation

 Introduction of a new heart failure drug class within the last 4 weeks prior to randomization

 Cardiovascular hospitalization within the last 2 weeks immediately prior to randomization

 Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization

 Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to randomization

 Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD) within 90 days prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization

 Need for any cardiovascular surgery

 Mitral valve surgery is considered a therapeutic option for the subject

 Renal replacement therapy

 Uncontrolled hypertension (i.e., BP >180 mmHg systolic and/or >105 mmHg diastolic) or hypotension (i.e., BP <90 mmHg systolic)

 Unstable angina pectoris as judged by the investigator, other clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias

 6MWT distance >450 meters

 Mitral Valve Area (MVA) by planimetry <4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory

 Leaflet anatomy which may preclude MitraClip device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation that may include:

 Evidence of calcification in the grasping area

 Presence of significant cleft in the grasping area

 Lack of both primary and secondary chordal support in the grasping area

 Prior mitral valve surgery

 Coaptation length ≤2 mm

 Leaflet mobility length <1 cm

 Presence of an IVC filter in the femoral vein that would interfere with the delivery catheter, or ipsilateral deep vein thrombosis (DVT) is present

 Contraindication to transseptal catheterization

 Subjects in whom transesophageal echocardiography is contraindicated

 Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

 Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)

 Presence of any of the following:

 Severe aortic stenosis (aortic valve area <1.0 cm2) or severe aortic regurgitation

 Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)

 Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology

 Hemodynamic instability requiring inotropic support or mechanical heart circulatory support

 Active infections requiring current antibiotic therapy

 Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically

 Severe right ventricular failure or severe tricuspid regurgitation

 History of bleeding diathesis or coagulopathy or subject who refuses blood transfusions

 Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to randomization and be adherent to an accepted method of contraception

 Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator

 Currently participating in another therapeutic or interventional heart failure trial, or in any trial of an unapproved drug or device (Subjects participating in observational studies or registries may be considered as eligible)

 Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures


Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.

Summary: Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through prospective observational data collection concerning specific items from the clinical and technical examination in diagnosing serious infections, such as meningitis, sepsis, pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate a vital signs and symptoms rule derived from multiple low to high prevalent settings of acutely ill children.
Inclusion criteria: inclusion criteria:

 Children aged 1 month to 16 years

 Acute illness episode of maximum 5 days

Exclusion criteria: :

 recent trauma

 neurological conditions

 intoxication

 psychiatric of behavioural disorders without a somatic cause

 acute exacerbation of a chronic condition (asthma, known immunodeficiency, diabetes, cystic fibrosis, etc)

['Community-Acquired Infections', 'Respiratory Tract Infections', 'Sepsis', 'Urinary Tract Infections', 'Meningitis', 'Gastroenteritis']

Community-Acquired Infections
Respiratory Tract Infections
Sepsis
Urinary Tract Infections
Meningitis
Gastroenteritis


Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Summary: The aim of this study is to compare the clinical effectiveness of intravenous esomeprazole and pantoprazole in preventing recurrent bleeding in the patients with high-risk bleeding peptic ulcers after successful standard endoscopic hemostasis.
Inclusion criteria: inclusion criteria:

 aged more than 18 years

 undergo emergent endoscopy within 24 hours of presentation

 have peptic ulcers in the gastroesophageal junction, stomach, or duodenum

 high-risk stigmata of peptic ulcers: Forrest classification IA

 IIB

 endoscopic hemostasis by thermocoagulation or clip placement

Exclusion criteria: :

 pregnant or lactating

 written informed consent not obtained

 initial endoscopic hemostasis fail

 bleeding tendency (platelet count < 50×109/L, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants)

 PPI use within 14 days of enrollment

 comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dL, serum creatinine more than 5 mg/dL, or under dialysis)

 bleeding gastric cancers


Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Summary: To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations, consultations, medications, and tests) of adequately controlling a patient (i.e. INR between 2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.
Inclusion criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

 inclusion criteria:

 Patients aged 18 or older over the study period

 Patients with a diagnosis for NVAF or VTE anytime in their medical records

 Patients having at least one year of enrolment in the database prior to the index date

 Patients newly initiated with VKA during the study period (index date)

Exclusion criteria: :

 Patients with a diagnosis for both NVAF and VTE anytime in their medical records


Impact of Exercise on Retinal Microvascular Regulation Measured by Dynamic Vessel Analysis in Healthy Individuals

Summary: Objective The investigators assessed the acute impact of physical exercise on retinal vessel regulation. This might be of clinical importance if retinal vessel regulation is examined with the very sensitive method of the dynamic vessel analyzer Design Forty middle aged (age range 18 to 31 years, mean age 24 years) healthy subjects (26 female / 14 male) had retinal examinations with static and dynamic vessel analysis prior and after (0.5h, 1.5h, 2.5h) intense exercise of 20 minutes.
Inclusion criteria: inclusion criteria:

 healthy middle-aged subjects

Exclusion criteria: :

 volunteers with systemic or ocular diseases

['Healthy Middle-aged Subjects', 'Age Range Was 18 to 31 Years', 'Caucasian Whites', 'Males and Females']

Healthy Middle-aged Subjects
Age Range Was 18 to 31 Years
Caucasian Whites
Males and Females