Plasma and Hemodynamic Markers During Hepatectomy

Summary: Introduction Liver resection is considered the only curative treatment option for mCRC patients without extrahepatic disease and is accepted practice. Despite substantial improvements in surgical techniques, postoperative morbidity and mortality remain an important concern after major resections. Complications of liver resection, although rare, include liver failure and acute kidney injury as indicated by oliguria and increased serum creatinine. The underlying pathophysiological pathways of post-operative renal alteration following liver resection is an increase in portal venous pressure, based on observations in animal models or small cohorts. The corpus of data is derived from patients with liver cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot distinguish between metabolic changes, portal hypertension and impaired liver function in the elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent model to evaluate the impact of portal hypertension on the kidney despite stable liver function.~The most significant factor determining morbidity and mortality following hepatectomy is the ability of the remnant liver to regenerate. In this context, several growth factors were shown to regulate the highly orchestrated process of liver regeneration (LR).~Hypothesis The investigators will therefore test the hypothesis that liver resection leads to a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal impairment, correlating with the quantity of resected liver.~Furthermore, the investigators will examine the relationship between postoperative liver regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based on the preclinical data the investigators hypothesize that a circulating growth factor levels will be associated with delayed liver regeneration, an increased incidence of postoperative liver dysfunction and concomitant worse clinical outcome.
Inclusion criteria: inclusion criteria:

 Patient with neoplastic liver tumors undergoing elective hepatectomy.

Exclusion criteria: :

 Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure

['Hepatorenal Syndrome, Liver Regeneration']


Safety and Efficacy of Single Daily Dose of Ceftriaxone and Metronidazole for Treatment of Complicated Appendicitis in Children

Summary: A prospective open randomized study conducted between July 1st 2008 and June 30th, 2009. Included were children younger than 14 years with Complicated appendicitis randomly assigned either to a single daily dose of Ceftriaxone and Metronidazole or Ampicillin, Gentamicin, and Metronidazole. The outcome variables compared were: maximum daily temperatures, overall duration of fever, time return to oral intake, length of antibiotic therapy, results of repeat WBC measure, general/intra abdominal complications, need for intra abdominal abscess drainage, Length of stay and adverse reaction.
Inclusion criteria: inclusion criteria:

 Children age 1-14 years CA that was defined by one of the followings:

 Demonstration by abdominal ultrasound (US) and/or computed tomography (CT) of appendix perforation and/or peri-appendicular abscess

 Demonstration by abdominal ultrasound (US) of free fluid, and signs of diffuse peritoneal irritation in the right lower quadrant of the abdomen 3

Exclusion criteria: :

 Documented allergy to any of the study medications, acute or renal insufficiency at admission, and severe septic shock at admission.

['ceftriaxone, metronidazole/ampicillin, gentamicin, and metronidazole']

ceftriaxone
metronidazole/ampicillin
gentamicin
and metronidazole


IOP Fluctuations in Primary Open Angle Glaucoma Patients Before and After Deep Sclerectomy With Collagen Implant

Summary: Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.
Inclusion criteria: inclusion criteria:

 Diagnosis of POAG

 Documented glaucomatous VF damage with mean defect (MD) > 3 dB

 Progressing glaucomatous damage justifying a DSCI

 Aged ≥18 years, of either sex

 Not more than 4 diopters spherical equivalent on the study eye

 Not more than 2 diopters cylinder equivalent on the study eye

 Have given written informed consent, prior to any investigational procedures

Exclusion criteria: :

 Corneal or conjunctival abnormality precluding contact lens adaptation

 Severe dry eye syndrome

 Patients with allergy to corneal anesthetic

 Patients with contraindications for silicone contact lens wear

 Patients not able to understand the character and individual consequences of the investigation

 Participation in other clinical research within the last 4 weeks


KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections

Summary: The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting.
Inclusion criteria: inclusion criteria:

 Subjects meeting all of the following criteria will be considered for enrollment into the study:

 Male and female adult outpatient subjects diagnosed with AECB or CAP

 Female subjects must be either postmenopausal for ≥ 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow ≤ 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control.

 Informed consent must be obtained in writing for all subjects upon enrollment.

 Subjects will have a diagnosis of AECB or CAP, as defined below.

 AECB-Specific inclusion criteria:

 Subjects greater than or equal to 35 years of age

 Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70%.

 Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume

 Subjects producing spontaneous sputum

 Subjects with a ≥ 10 pack-year history of cigarette smoking

 CAP-Specific inclusion criteria:

 Fever (oral temperature > 38°C [100.4°F] or tympanic temperature > 38.5°C [101.2°F] or rectal temperature > 39°C [102.2°F])

 Chills

 Pleuritic chest pain

 Cough

 Spontaneous production of purulent sputum or a change in sputum character

 Auscultatory findings (such as rales [also known as crepitations] and/or evidence of pulmonary consolidation [ie, dullness on percussion, bronchial breath sounds, egophony])

 Subjects greater than or equal to 18 years of age

 Chest x-ray findings that support a clinical diagnosis of bacterial pneumonia (eg, presence of presumably new infiltrate[s])

 Subjects with a clinical diagnosis of mild to moderate CAP due to bacterial infection based on at least 1 of the following signs and symptoms of CAP:

 In addition, subjects with a clinical diagnosis of CAP will have at least 1 of the following signs and symptoms of CAP:

 Dyspnea or tachypnea (particularly if progressive in nature)

Exclusion criteria: :

 Subjects presenting with any of the following will not be included in the study:

 Subjects with a known history of congenital long-QTc syndrome

 Subjects who are pregnant or breast-feeding

 Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics

 Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study

 Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax)

 Subjects who have previously participated in this study

 Subjects with a previous history of myasthenia gravis

 Subjects with current acute respiratory failure or subjects who require aggressive airway management

 Hospitalized subjects and subjects from institutional care facilities

 Subjects who have been treated with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than study drug during the treatment period

 Subjects who are receiving other medications, including systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety

 Subjects with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that makes either implementation of the protocol or interpretation of the study results difficult

 Subjects with a progressively fatal disease or life expectancy of < 3 months

 Subjects who have received any other investigational drug or device within 1 month prior to study entry, or who have such treatment planned during the study period

 Subjects with a recent (within 3 months) history of drug or alcohol abuse

 Immunocompromised subjects, including but not limited to subjects with: known human immunodeficiency virus infection (CD4 count < 200/mm3); known neutropenia (< 1500 neutrophils/mm3); chronic corticosteroid therapy (≥ 10 mg/day prednisolone therapy or equivalent for at least the past 3 months); immunosuppressant treatment, other than corticosteroids, within the previous 6 months; splenectomized subjects or subjects with known hyposplenia or asplenia.

 Subjects with mental conditions that render them unable to understand the nature, scope, and possible consequences of the study

 Subjects who are unlikely to comply with the protocol (eg, have an uncooperative attitude, an inability to return for follow-up visits, or are unlikely to complete the study)

 Subjects who have known impaired hepatic function

 Subjects who have known impaired renal function

 AECB-Specific

['Respiratory Tract Infections', 'Chronic Bronchitis', 'Pneumonia']

Respiratory Tract Infections
Chronic Bronchitis
Pneumonia


Pet Ownership and Glucose Control in Type 1 Diabetes

Summary: The investigators' long-term goal is to discover novel, inexpensive and feasible strategies to improve the management and well-being of youth with T1DM. The specific objective of this proposal is to quantify the impact of responsible pet ownership on the glycemic control and health related quality of life in youth with T1DM.
Inclusion criteria: inclusion criteria:

 English-speaking patients

 10 to 18 years

 diagnosed with type 1 diabetes for at least 12 months

 poor diabetes control as defined by having a hemoglobin A1c value > 8%

Exclusion criteria: :

 type 2 diabetes

 developmental delay

 current participation in another study that may impact glycemic control


The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD

Summary: This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).
Inclusion criteria: inclusion criteria:

 COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study

Exclusion criteria: :

 COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.


Effect of Curodont Repair in Patients With Early Approximal Carious Lesions

Summary: The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to no treatment.
Inclusion criteria: inclusion criteria:

 Two approximal carious lesions on different teeth with at least one tooth in between

 Both study lesions must not require an invasive treatment

 Size and form of the lesions: the lesions must be fully visible and assessable on radiographs

 The two carious lesions must fall into classes:

 D1 (outer half of enamel) D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)

 Able and willing to observe good oral hygiene throughout the study

 Age ≥ 18 years and ≤ 65 years

 Willing and able to attend the on-study visits

 Willing and able to understand all study-related procedures

 Written informed consent before participation in the study

Exclusion criteria: :

 The two study test lesions are located on adjacent teeth

 Fluoride varnish application < 3 months prior to study treatment

 Tooth with numerous carious lesions

 Evidence of tooth erosion

 History of head and neck illnesses (e.g. head/neck cancer)

 Any pathology or concomitant medication affecting salivary flow or dry mouth

 Any metabolic disorders affecting bone turnover

 Patient suffers from diabetes

 Concurrent participation in another clinical trial

 Women who are breast-feeding, pregnant or who plan a pregnancy during the study

 Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner

['Curodont Repair', 'No treatment - control']


Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS Study)

Summary: Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT). Since there are still uncertainties as to whether and in what patients revascularization by means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study exploiting an optimized patient selection strategy and using hard experimental endpoints to unravel these uncertainties.~Primary objective: to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.~Secondary objectives: to determine if the two treatments are equivalent in lowering blood pressure (BP), preserving overall renal function and regressing damage in the target organs of hypertension.~Design: prospective multicenter randomized, unblinded two-arm study.~Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral RAS, defined by stenosis of the proximal portion of the renal artery and its main bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could bias the assessment of the outcome of revascularization.~Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation.~Renal function will be assessed with 99mTc-DTPA renal scintigraphy.~Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.~Arms~Revascularization: digital scan angiography and PTA with stenting of the renal artery at the ostium or at truncular level, plus optimal medical therapy.~Medical therapy: the drug regimen that had been optimized during the run-in period.~Experimental endpoints:~The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as quantitative variable and compared between groups at each time point. A categorical definition of kidney loss, defined as a GFR in the ischemic kidney of < 5 ml/min, will be also used and the rate of achievement of such endpoint will be compared.~Duration: 5 years.
Inclusion criteria: inclusion criteria:

 RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation AND

 resistance index (RI) < 0.55 or > 0.55 but < 0.80 with evidence of intrarenal heterogeneity of the RI as revealed by a CV > 10% in the RI across the upper, mid and lower third of each kidney.

Exclusion criteria: :

 refusal to participate to study,

 previous endovascular or surgical treatment of RAS,

 fibromuscular RAS,

 planned or actual pregnancy, or childbearing potential without measures adequate to prevent pregnancy,

 life expectancy < 2 years,

 patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,

 co-morbid conditions limiting participation and follow-up.

['Optimal medical therapy', 'revascularization']

Optimal medical therapy
revascularization


Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract

Summary: Group A streptococcus (GAS) causes a variety of human infections. It is also an uncommon but serious cause of postpartum infections. In contrast to group B streptococcus (GBS) infection, which causes illness and death in newborns disproportionately more often than it does in mothers, perinatal GAS infection primarily affects mothers . Invasive GAS infection is defined by the isolation of GAS from a normally sterile site (e.g., blood) or by the isolation of GAS from a nonsterile site in the presence of the streptococcal toxic shock syndrome or necrotizing fasciitis. A postpartum case of invasive GAS is defined as isolation of GAS during the postpartum period, in association with a clinical postpartum infection (e.g., endometritis) or from either a sterile site or a wound infection.~Because of the burden and severity of invasive GAS infection, the Centers for Disease Control and Prevention (CDC) hosted a meeting in to formulate guidelines for responding to postpartum and postsurgical GAS infections. However, we could not find any recommendations for long-term follow-up of patients who had GAS infection subsequent to delivery or gynaecological procedures, or further recommendations regarding subsequent delivery or gynaecological invasive procedures. It is possible that women who had GAS as a cause of vaginal infection may have a tendency to be carriers of this organism, but this has never been proven. We believe it is of importance to determine if women who have had one infection may be long-term carriers which may pose a risk during future pregnancies.~The objective of the present study is to evaluate the incidence of long term gynaecological carrier state of patients who had GAS invasive infection following delivery, and to provide guidelines for follow-up and treatment of such patients.~The proposed study may answer the question whether this endogenous GAS origin represents chronic GAS carrier state, similar to the known GBS carrier state. As some of these patients had severe infections (sometimes life threatening) a protocol for long-term follow up and management is necessary in case an invasive procedure is done (IUD insertion, endometrial biopsy, curettage or delivery) in order to prevent recurrent infection. The information collected in the study will enable us to afford recommendations for follow up and prophylaxis in the future.~.
Inclusion criteria: inclusion criteria:

 Patients diagnosed with GAS infection/isolation in the past 3 years (2003-2005)
Exclusion criteria:


WASH Benefits Bangladesh

Summary: Brief Summary:~The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.
Inclusion criteria: inclusion criteria:

 (1) Infants (target child) will be eligible to participate in the study if they are:

 They are in utero at the baseline survey

 Their parents/guardians are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still be a candidate for enrollment)

 (2) Children < 36 months old at baseline that are living in the compound of a target child will be eligible to participate in diarrhea measurement if:

 They are < 36 months old at the baseline survey

 Their parents/guardians are planning to stay in the study village for the next 12 months

 (3) Children 18 - 27 months old at baseline that are living in the compound of a target child will be eligible to participate in intestinal parasite specimen collection if:

 They are 18 - 27 months old at the baseline survey

 Their parents/guardians are planning to stay in the study village for the next 12 months
Exclusion criteria:

['Water quality', 'Sanitation', 'Hand washing', 'Water quality, Sanitation, Hand washing (Combined WASH)', 'Nutrition', 'Nutrition, Water quality, Sanitation, Hand washing']

Water quality
Sanitation
Hand washing
Water quality
Sanitation
Hand washing (Combined WASH)
Nutrition
Nutrition
Water quality
Sanitation
Hand washing

['Malnutrition', 'Diarrhea', 'Child Development']


Pleural Sliding During Valsalva and Muller Maneuvers

Summary: Recently, ultrasound artifacts mimicking lung sliding have been described in absence of the visceral pleura, in a group of patients who underwent pneumonectomy. In these patients, lung sliding was clearly absent during mechanical ventilation in the operated hemithorax. During spontaneous breathing, although of lower intensity compared to the unoperated hemithorax, some artifacts mimicking lung sliding and seashore sign were found during each deep spontaneous breath. These findings have led to the hypothesis that these artifacts may be due to the contraction of the intercostal muscles.~The objective of the present study is to reproduce such artifacts during contraction of the inspiratory and expiratory muscles with closed glottis (Valsalva and Muller maneuvers): in this condition each subject is not ventilating and the two pleural layers are not sliding one over each other.
Inclusion criteria: inclusion criteria:

 Twenty healthy male volunteers aged between 18 and 65 years-old with no history of respiratory or cardiovascular pathologies will be enrolled.

Exclusion criteria: :

 Females and all subjects with history of respiratory or cardiovascular diseases will be excluded.


A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy

Summary: AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of systemic therapy with CMV retinitis.~AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3. Nonrandomized eyes will not be used for the primary efficacy evaluation.~ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of the eye by injection.~CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis.
Inclusion criteria: inclusion criteria

 Concurrent Medication:

 Allowed:

 Zidovudine (AZT).

 AMENDED: 8/8/90 Other available antiretroviral therapy.

 Pneumocystis carinii pneumonia (PCP) prophylaxis, either systemic or local (aerosolized).

 Chemotherapy for Kaposi's sarcoma.

 Systemic therapy for intercurrent opportunistic infections.

 Acyclovir or other treatment of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections.

 Systemic therapy deemed necessary for appropriate medical management.

 Patients must have AIDS and cytomegalovirus (CMV) retinitis in at least one eye, diagnosed by an ophthalmologist and verified by fundoscopy and fundus photography.

Exclusion criteria:

 Co-existing Condition:

 Patients with the following are excluded:

 Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage.

 Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.

 Concurrent Medication:

 Excluded:

 Prophylactic acyclovir at time of study entry.

 Other anticytomegalovirus (CMV) therapy, particularly systemic ganciclovir, foscarnet, or CMV hyperimmune globulin.

 Topical ophthalmic medications should be avoided.

 Cytomegalovirus (CMV) therapies and chronic acyclovir, including necessary therapies for an intercurrent opportunistic infection.

 Patients with the following are excluded:

 Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage.

 Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.

['Cytomegalovirus Retinitis', 'HIV Infections']

Cytomegalovirus Retinitis
HIV Infections


Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty.

Summary: There are many different views regarding ideal duration and type of thromboprophylaxis after hip or knee surgery.~An important factor in Fast-track surgery is early mobilization, which in itself is thought to prevent clotting.~The investigators hypothesize that there is no increase with regards to thrombosis in patients receiving fast-track surgery with early mobilization and chemical thrombosis prophylaxis only during hospitalization.
Inclusion criteria: inclusion criteria:

 primary Uni/bilateral THR/TKR, revision THR/TKR or uni-KR in fast-track setup, Discharged in 3 +-2 days.

Exclusion criteria: :

 not a danish citizen

['Thromboembolic Events', 'Post-operative Bleeding']

Thromboembolic Events
Post-operative Bleeding


Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

Summary: Using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups:~allergic rhinitis to dust mite (AR) isolated (n=12),~AR associated with bronchial hyperreactivity (n=12),~AR associated with asthma (n=14),~control (n=14).
Inclusion criteria: inclusion criteria:

 Patients:

 Patients between 6 and 17 years old

 Patients with allergic rhinitis

 Witness:

 Patients between 6 and 17 years old

 Patients without allergic rhinitis and asthma

Exclusion criteria: :

 Rhino-bronchitis infection dated from less than 15 days

 Patients younger than 6 or older than 17 years

['Collection of nasal epithelial cells']


A Comparison of Appendicectomy Outcomes in Children Between Paediatric and General Surgical Centres in Scotland

Summary: Introduction~Appendicectomy (or appendectomy in US usage) is the single most commonly performed emergency surgical operation performed on British children. Previous investigation of outcomes following appendicectomy has suggested that specialist surgeons and high volume centres have fewer negative appendicectomies (i.e. the appendix found to be non-diseased), although there has not been consistent association found between hospital type or surgeon experience and complication rate or admission rate.~Scotland has 3 dedicated children's surgery centres but straightforward children's surgery such as appendicectomy is also carried out in the country's general surgical centres. Appendicectomy outcome variations have not been explored in the Scottish National Health Service (NHS).~Aim~This study will compare appendicectomy outcomes in children between Scotland's specialist paediatric centres and general surgical centres.~Methods~This is a retrospective study of all appendicectomies performed in Scotland during the period from 1st January 2001 - 31st December 2010, on children aged 2 - 12 years old. It will use routinely collected administrative data from the Information Services Division of NHS National Services Scotland.~The study will compare risk-adjusted 30 day/in-patient mortality, 30 day re-admission rate, 30 day re-operation rate, post-operative length of stay and negative appendicectomy rates.
Inclusion criteria: inclusion criteria:

 All patients aged 2 - 12 years old who within the 10 year period of January 2001 - December 2010 are entered on the SMR01 database as having a code for appendicectomy.

 Episodes will be extracted with the following codes:

 OPCS (Office of Population Censuses and Surveys), revision 4.5

 H01 Emergency excision of appendix

Exclusion criteria: :

 We will exclude patients for whom incidental appendicectomy has occurred at the same time as another major abdominal surgical procedure.

 We will exclude patients who are non-resident in Scotland since we will be unable to derive depravity index and urban-rural classification, and may not have access to information on co-morbidities and mortality.


ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD

Summary: Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.~The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD )
Inclusion criteria: inclusion criteria:

 Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ.

Exclusion criteria: :

 Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included

['Chronic Obstructive Lung Disease (COLD)']


A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis

Summary: The purpose of this study is to compare the efficacy and safety of two treatment regimens in treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment when the appendix ruptures (complicated appendicitis). This is a study comparing intravenous (IV) antibiotic therapy of levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to 14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's discretion.
Inclusion criteria: inclusion criteria:

 Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis

 Able to take medicine orally after recovering from surgery

 If female, using birth control

Exclusion criteria: :

 History of allergy to any study medication

 Life expectancy < 72 hours

 APACHE II (health) score > 25

 Neutropenic (low white blood cell count)

 HIV positive with current or past CD4 count < 200/mm^3

 Low platelet count (bleeds easily)

 Malnourished with low albumin

 Condition requiring use of major tranquilizers


The Effect of Adding Pain Relievers to Local Anesthesia Before Preforming Drainage in Peritonsillar Abscess

Summary: The purpose of this study is to find if adding oral pain relievers as DYPIRON and TRAMADOL in addition to the local anesthesia injection, can help reducing the pain intensity in patients who diagnosed as Suffering from peritonsillar abscess (PTA)and treated by incision and drainage .
Inclusion criteria: inclusion criteria:patients with PTA in ages 18-65, who agreed to join the research -

Exclusion criteria: :cave to dypiron and/or tramadol, pregnant women, mental illness,soldiers.

 -


Retinal Neurodegenerative Signs in Alzheimer's Diseases

Summary: A few studies suggest that patients suffering from neurodegenerative diseases (such a multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a precise and standardized estimation of this parameter, which could constitute a biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD, prior to damage of the hippocampal region that impacts memory.~Besides, some associations of AD with some degenerative diseases of the eye (glaucoma, microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.~It therefore seems interesting to determine whether RNFL thickness, and other ocular parameters, may give some indications for a better detection of AD and cognitive decline in the elderly.
Inclusion criteria: inclusion criteria:

 inclusion criteria for AD cases:

 Diagnosis of probable AD, defined according to the NINCDS-ARDRA criteria51

 Light to moderate severity of the disease, defined by a MMSE score >10 (global evaluation of cognition)

 Patient aged 50 years or more

 Patient benefiting from social insurance

 inclusion criteria for controls:

 Absence of suspicion of dementia, based on normal performance according to age and educational level at neuropsychological testing defined as:

 Free recall ≥17 and total recall ≥40 for the Free and Cued Selective Reminding Test (Grober and Buschke test 52) MMSE ≥ norm for age and educational level (defined by mean - 1 SD)

 Isaac's set test ≥ norm for age and educational level (defined by mean - 1 SD)

 Matched to age and gender of the cases

 Patient benefiting from social insurance

Exclusion criteria: :

['Ophthalmological examination & Questionnaire']


Delayed Renal Allograft Function and Furosemide Treatment

Summary: This study will be a randomized prospective double-blind placebo-controlled clinical pilot trial. This will be a single center project that will take place at Loma Linda University Medical Center. All adult kidney recipients will be informed of the study prior to operation. The Nephrology fellows or attending physicians will attempt to obtain informed consent from all eligible patients, pre-transplant. Those patients who consent will be screened post operation for enrollment. Patients who do not meet all eligibility criteria and/or who meet some exclusion criteria will be deemed ineligible for the trial, and will be excluded. The Nephrology and Transplant teams will be blinded of patient assignment and only the pharmacy will know the patient's assignment.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years

 Patient with ESRD who has been on RRT (Hemodialysis or Peritoneal dialysis)

 Recipient of deceased donor kidney transplant

 Urine output less than 0.5 mL/kg/h before transplant

 Patient consents to the study

 Patient is not allergic to furosemide or sulfa

 English or Spanish speaking patient

 Patient is oliguric (urine output less than 0.5mL/kg/h, as per AKIN criteria) or anuric (urine output less than 10 mL in 6 hours post-transplant or 2 mL/h) in the first 6 hours post kidney transplant

Exclusion criteria: :

 Recipients of a living donor kidney transplant

 Patients who do not consent for the study

 Patients age <18 years

 Patients who are allergic to furosemide or sulfa containing medications

 Non-oliguric patients

 Patients who require immediate dialysis within 6 hours of the transplant (before enrollment)

 Patients with renal ischemia due to vascular compromise that has been confirmed with Doppler Ultrasound right after transplant as per standard of care

 Patients who return to the operating room due to complications within 24 hours

 Simultaneous multi-organ transplant recipients

 Hypotensive patients with BP <90/60 or MAP <60 mmHg

 Patients who are on vasopressors at any time during study period

 Non-English or Spanish speaking patient


Balance Training in Parkinson's Disease Using Cues

Summary: Verifying the efficiency of motor training associated with visual and auditory cues on the balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's Disease (PD), for prevent fall rate in people with PD. It is a single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Inclusion criteria: inclusion criteria:

 Elderly

 The patient is able to provide informed consent.

 Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist

 Hoehn and Yahr Stage 1-3

 Able to ambulate without an assistive device

 On stable doses of Parkinson's medications prior to study onset

Exclusion criteria: :

 Mini Mental Status Exam (MMSE) < 24

 Change in Parkinson's medications in the duration of study

 Uncontrolled orthostasis

 Symptomatic coronary artery disease

 Fracture of lower limb prior to study onset

 Other neurologic diagnosis

 Physical therapy before and during to study duration

 Significant camptocormia

 Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.

['Disturbance; Balance, Labyrinth', 'Parkinson´s Disease']

Disturbance; Balance
Labyrinth
Parkinson´s Disease


Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial

Summary: The first objective is to determine the efficacy of calcium and vitamin D supplementation at doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in non-institutionalized elderly people.~The second objective is to measure and compare treatment groups (calcium and vitamin D vs placebo) as regards muscle strength and musculoskeletal function, bone mineral density, calcidiol level and treatment safety.
Inclusion criteria: inclusion criteria:

 Aged over 65 years with normal renal function

 Normal transaminase levels

 Normal calcium blood levels

 Not homebound (not immobilized) nor in socio-healthcare institutions.

Exclusion criteria: :

 Need for medical treatment with calcium or vitamin D

 Hypersensitivity to or contraindication for calcium or vitamin D

 Medical treatment that includes calcium or vitamin D

 Physical disability that impedes their collaboration

 Taking thiazide diuretics

 Oral anticoagulants

 Hormone replacement therapy

 Digitalis drugs

 Anticonvulsants or barbiturates

 Having any of the following diseases:

 Lithiasis

 Renal impairment (serum creatinine >1.4 mg/dl)

 Hypo or hyperthyroidism

 Paget's disease

 Chronic liver disease

 Tumors

 Sarcoidosis

 Impaired intestinal absorption or chronic alcoholism (>40 g/day).

['Vitamin D and calcium suplementation']


Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis

Summary: The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.
Inclusion criteria: inclusion criteria:

 hospitalisation in the hematology or intensive care department

 age > 16 years

 informed consent

 proven or probable IPA (EORTC/ MSG criteria)

 galactomannan positivity in BAL or serum

Exclusion criteria: :

 age < 16 years


Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant

Summary: The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have undergone bone marrow or peripheral blood stem cell transplant.
Inclusion criteria: inclusion criteria:

 Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center.

 An initial episode of CMV viremia.

 At the time of randomization:

 ANC greater than or equal to 1000

 Age greater than or equal to 18

 Adequate renal function with creatinine clearance greater than 10 ml/min

 Total bilirubin less than or equal to 3.0

Exclusion criteria: :

 Current GI graft versus host disease grade III-IV

 Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR

 Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days

 Pregnant or nursing female patient

 Known hypersensitivity to ganciclovir


Vasoactive Intestinal Peptide in COPD

Summary: This study, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP) was evaluated. Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.~34 patients with severe COPD were treated either with VIP inhalation in addition to conventional therapy or inhalation of placebo plus conventional therapy for a period of 3 months. The trial was conducted as a double blind, comparative study with two parallel groups.
Inclusion criteria: inclusion criteria:

 Confirmed moderate to severe COPD with or without pulmonary hypertension

 Male and female patients.

 Aged 18 - 75 years.

 Written consent.

 Adequate contraception in female patients of childbearing age.

 Negative pregnancy test (four-weekly test repetition).

Exclusion criteria: :

 Lack of consent

 Pregnancy (four-weekly tests)

 Lactation

 Presumed non-cooperativeness

 Patients outside the stipulated age range

 Myocardial infarction within the last 12 months

 Stroke within the last 12 months

 Malignant diseases in anamnesis

 Legal incapacity

 Parallel participation in a clinical trial

 Parallel participation in a clinical trial within the last 4 weeks


Mechanisms That Produce the Leg Dysfunction of Claudication (Leg Pain and Limping During Walking) and Treatment Strategies for the Care of Patients With Claudication

Summary: Intermittent claudication afflicts 5% of the US population older than 55 years of age and develops along with hardening of the arteries of the legs. Claudicating patients limp and can only walk very short distances because their legs hurt. This protocol evaluates the mechanisms that may produce the leg dysfunction of claudication and its successful completion can ultimately produce significant new diagnostic and treatment strategies for the care of claudicating patients.
Inclusion criteria: inclusion criteria:

 a positive history of chronic claudication

 exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon

 an ankle/brachial index < 0.90 at rest

Exclusion criteria: :

 absence of Peripheral Arterial Disease (PAD)

 acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma

 exercise capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

['Revascularization Surgery', 'Supervised exercise therapy']

Revascularization Surgery
Supervised exercise therapy


Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder

Summary: The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy for children with neurogenic bladder due to spina bifida and compare results with standard oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain or improve bladder storage function without side effects associated with oxybutynin use.
Inclusion criteria: inclusion criteria:

 Diagnosis of spina bifida and neurogenic bladder

 Performing clean intermittent catheterization (CIC)

 Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder

 Has not had previous bladder surgery

 Has had a urodynamic or videourodynamic study done within the last 6 months

 Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study

 Urodynamic study (UDS) showing either detrusor leak point pressure >40cm H2O; 30cm below capacity <60% of total bladder capacity, 20 cm capacity <70% of bladder capacity

 Able and willing to complete CIC Diaries and Quality of Life Questionnaires

 Consent and assent given to participate in trial

Exclusion criteria: :

 History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia

 Positive urine culture

 Known allergy to Botox

['Oxybutynin', 'Botulinum Toxin A injection']


Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis

Summary: The main objective of this study : Demonstrate that GBS (group B streptococci) ST-17 colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS non-ST-17.~Secondary objectives:Determine:~The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant women.~The frequency of colonization of neonates by GBS ST-17 at birth.~The preferential site of colonization in the mother (rectum, vagina, breast milk).~The kinetics of colonization after birth in the newborn.~The sensitivity and specificity of different GBS detection methods (conventional phenotypic versus molecular) in the different types of samples from the mother and the newborn.
Inclusion criteria: inclusion criteria:

 Patient having a positive vaginal swab for GBS at the end of pregnancy (PCR +).

 Patient aged over 18 years

 Patient who received information and agreeing to sign informed consent

 Patient affiliated or beneficiary of an insurance

Exclusion criteria: :

 - Patient does not speak and does not understand French

['Neonatal Infections Colonize With Group B Streptococci']


A Study of the Effectiveness of Different Types of Exercise for People With Knee Osteoarthritis

Summary: This pilot study will test the testing and exercise training protocols for a larger study that is in the desing phase and may be modified based on the findings of this study. Two exercise groups will be compared; one is a stadard treatment group using leg strength exercises that are commonly employed in therapy clinics. The other group will do balance and agility type exercises, but no specific strength exercises. These KBA exercises are increasingly common in therapy clinics, but very little research has been conducted on their effectiveness in treating knee osteoarthritis symptoms. Participants in this study will complete three short paper and pencil tests at the beginning and end of the study (8 weeks of exercise) as well as a leg strength test, a leg endurance test, two short walking tests, and a stair climb/descend test. One of the paper and pencil tests will be taken every two weeks in an effort to see how quickly changes to symptoms might occur. The exercise programs will be conducted 3 afternoons per week (Mon-Wed-Fri) and will be lead by an ACSM certified instructor.
Inclusion criteria: inclusion criteria:

 Aged 50 years or over of either gender

 Radiographic tibiofemoral OA grade 2 or higher, unilateral or bilateral

 Demonstrated knee OA related dysfunction per WOMAC score

 Not engaged in a regular exercise program for minimum of 6 months

Exclusion criteria: :

 Inability to obtain physician release for exercise

 High risk health status:

 e.g., uncontrolled medical conditions such as hypertension, diabetes, heart disease, pulmonary disease, high cholesterol, anginal type pain, dizziness or syncope, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, heart palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue or shortness of breath with usual activities.

 Unresolved balance disorder

 Unresolved neurological disorder

 History of knee surgery or major knee trauma injury

 Hip or ankle instability, excessive weakness, surgery or major trauma injury

 Intra-articular joint injection within 4 weeks of the study

['Kinesthesia, Balance, and Agility (KBA) Exercise', 'Standard LE Strength Training']

Kinesthesia
Balance
and Agility (KBA) Exercise
Standard LE Strength Training


Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion

Summary: RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known whether one drug is more effective than the other in lessening pleurodesis-related pain or whether the size of the chest drain tube affects pain.~PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works compared with morphine in treating pain in patients undergoing pleurodesis for malignant pleural effusion.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following:

 Histologically proven pleural malignancy

 Typical features of pleural malignancy seen on direct vision during thoracoscopy

 Pleural effusion in the context of histologically proven cancer elsewhere

 No primary lymphoma or small cell lung carcinoma

 All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible

 PATIENT CHARACTERISTICS:

 Life expectancy > 1 month

 Not pregnant or nursing

 No history of GI bleeding or untreated peptic ulceration

 No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol

 No hypercapnic respiratory failure

 No known intravenous drug abuse

 No severe renal or liver disease

 No known bleeding diathesis

 Able to give informed consent

 PRIOR CONCURRENT THERAPY:

 More than 2 weeks since prior and no concurrent corticosteroid therapy

 No concurrent warfarin therapy

 No other concurrent analgesics

 Analgesics used as a breakthrough regimen are allowed from trial entry to tube withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study analgesia, and breakthrough medication only, including opiate slow release patches)

 No concurrent enrollment on another clinical study

 Patients may participate in other trials immediately after completion of current trial, excluding those involving further pleural procedures or analgesia trials in which patients must wait at least 3 months after completion of current trial
Exclusion criteria:

['ibuprofen', 'morphine sulfate', 'management of therapy complications', 'pleurodesis']

ibuprofen
morphine sulfate
management of therapy complications
pleurodesis


Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

Summary: This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.
Inclusion criteria: inclusion criteria:

 Subjects must be 18 years of age or older.

 Ability to provide written informed consent.

 Likely to complete all study visits.

 Subjects must have one eye that with a diagnosis of infectious keratitis.

Exclusion criteria: :

 A corneal perforation.

 Descemetocele.

 Pregnancy or breastfeeding.

 Active Herpes corneal disease.

 Patient is unwilling or unable to comply with a medication regimen and follow up appointments.


Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A

Summary: Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years.

 End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation.

 Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor.

 Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type.

 Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug.

 Total ischemia time below 36 hours.

 Capable of understanding the purpose and risks of the study.

 Fully informed and having given written informed consent (signed Informed Consent has been obtained).

 Affiliation to the social security regimen

Exclusion criteria: :

 CMV seronegative patient.

 Historical or current TGI (French equivalence of calculated PRA) > 85 %

 Presence of historical or current anti-HLA donor specific antibodies

 Patient who received anti-CMV therapy within the past 30 days prior to screening.

 Receiving or having previously received an organ transplant other than a kidney.

 Receiving a graft from a non-heart-beating donor.

 Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV; HBs Ag positive) or Hepatitis C (HCV; anti-HCV Ab positive).elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or receiving a graft from a hepatitis C or B positive donor.

 Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.

 Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients.

 Severe hyperlipidemia defined by: total cholestérol ≥ 9,1 mmol/L (≥ 350 mg/dL) et/ou triglycérides ≥ 8,5 mmol/l (≥ 750 mg/dL) in spite an adequate medication.

 Patient has adequate hematological post-transplant defined as:

 Absolute neutrophil count (ANC) > 1000 cells/μL.

 Platelet count > 50,000 cells/μL.

 Hemoglobin > 8.0 g/dL.

 Requiring initial therapy with induction immunosuppressive antibody preparations, such as anti-thymocyte globulins or rituximab or IVIG.

 Currently participating in another clinical trial investigating drugs. Observational studies are not considered as an

['Transplantation Infection', 'Cytomegalovirus Infection']

Transplantation Infection
Cytomegalovirus Infection


Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy

Summary: The two specific aims of this study are 1) to assess the relative contributions of two major maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to the fetus, and 2) to determine the impact of maternal and fetal iron status on placental transfer of these two iron sources in pregnant women and adolescents during the last trimester of pregnancy.
Inclusion criteria: inclusion criteria:

 Singleton pregnancy

 Non-smoker

 No pre-existing medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis)

Exclusion criteria: :

 Complicated pregnancy (including gestational diabetes, pregnancy-induced hypertension, or preeclampsia)

 Individuals been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study


A Polymerase Chain Reaction (PCR) - Based Method to Improve Antibiotic Prescribing for Pneumonia

Summary: Pneumonia, or lung infection, is usually treated with antibiotics targeted against the organisms that the physician guesses are causing the problem. The determination of the exact cause of a patient's pneumonia is difficult. The problem is that the two major causes of community-acquired pneumonia are not easily distinguished on clinical grounds and are best treated by different antibiotics. The investigators hypothesize that antibiotic therapy can be targeted and improved by doing polymerase chain reaction (PCR) testing of nose swabs to identify probable implicated organisms and their antibiotic resistance patterns. This pilot study will be important to ensure that the laboratory testing is functional and that the emergency department-laboratory communication is optimal prior to doing a full-fledged randomized clinical trial.
Inclusion criteria: inclusion criteria:

 presumed community-acquired pneumonia as diagnosed by the attending emergency department physician

Exclusion criteria: :

 age > 6 months

 immunodeficiency (primary, advanced HIV)

 cystic fibrosis

 malignancy

 known cardiac or lung defects

 bronchiectasis

 previous pneumonia or lung abscess in past 6 months

 conditions requiring treatment with immune suppressants


The Research Registry for Neonatal Lupus

Summary: Women with lupus and other related disorders produce certain antibodies in the blood. Some women have these antibodies even if they have not yet developed symptoms of lupus or Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their infants. The infants may then develop a disease called neonatal lupus. The symptoms of neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This registry collects information on women and infants affected by neonatal lupus as well as other family members who may be healthy.
Inclusion criteria: inclusion criteria:

 Mother with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins (RNP) OR Child of mother with such antibodies who has neonatal lupus (congenital heart block, transient skin rash, and/or hepatic or hematologic manifestations) OR Father of neonatal lupus-affected child OR Maternal grandparents of neonatal lupus-affected child OR Maternal aunts and uncles of neonatal lupus-affected OR Unaffected siblings of neonatal lupus-affected child
Exclusion criteria:

['Neonatal Lupus', 'Systemic Lupus Erythematosus', "Sjogren's Syndrome", 'Congenital Heart Block']

Neonatal Lupus
Systemic Lupus Erythematosus
Sjogren's Syndrome
Congenital Heart Block


Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression

Summary: This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT) in treating women with depression and comorbid substance abuse.
Inclusion criteria: inclusion criteria:

 pregnant or has delivered in the past year

 reports the use of an illegal drug and/or consumption of 4 or more drinks on one occasion within the last 6 months; if postpartum, report the use of an illegal drug and/or consumption of 4 or more drinks on one occasion or 7 or more drinks in a week within the last 6 months; if pregnant, report the use of an illegal drug within the last 6 months and/or the consumption of 2 or more drinks in one month while pregnant, along with a history of consumption of 4 or more drinks on one occasion or 7 or more drinks in a week within 3 months pre-pregnancy

 meets DSM-IV criteria of current Major Depressive Disorder (MDD) by Structured Clinical Interview for the DSM-IV(SCID) interview;

 has a 17-item Hamilton Rating Scale for Depression (HRSD) score > 16, indicating moderate to severe depression;

 is between 18 and 50 years old; and

 is able to speak and read English sufficiently to be able to complete the study procedures

Exclusion criteria: :

 meets lifetime criteria for:

 bipolar disorder

 a primary psychotic disorder

 anorexia nervosa

 bulimia nervosa

 has started an SUD or MDD medication dose within the 8 weeks prior to enrollment

 is imminently suicidal

['Sober Network Interpersonal Psychotherapy (IPT)', 'Treatment as Usual']


A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia

Summary: The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.
Inclusion criteria: inclusion criteria:

 Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older.

 Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage [BAL], protected brushing specimen [PBS]), or should have appropriate specimens highly likely to identify the pathogens sampled. (However, the patients with Legionellosis is enrolled when the test of Legionella antigen is positive.)

 The following severe bacterial pneumonia meeting the diagnostic criteria of pneumonia or secondary infection of chronic respiratory disease

 Severe pneumonia

 Community-acquired pneumonia: PORT score III, IV or V

 Hospital-acquired pneumonia [HAP]-Group B and with a low risk for multidrug-resistant pathogens

 Patients with [HAP]-Group A whose pathogen is suspected to be Pseudomonas aeruginosa

 Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with-Group A or B who don't respond to or have a poor response to other antimicrobials over 3day's treatment.2

 Secondary infection of chronic respiratory disease

 Patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease

 Hospitalized patients with secondary infection of chronic respiratory disease with a poor response to other antimicrobials Note: The patients should be limited to secondary infection of chronic respiratory disease patients who don't respond to or have a poor response to other antimicrobials over 3day's treatment.

Exclusion criteria: :

 Creatinine clearance (Ccr) ≤ 30 mL/min or nephrotic syndrome

 Patient with chronic treatment of immunosuppressive drug

 Decompensated congestive heart failure

 Subject who received more than 24 hours of an antibacterial drug for the current infection

 Patient who requires Intensive Care Unit (ICU) management [In case subjects who don't correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded]

 Patients with infections other than pneumonia or secondary infection of chronic pulmonary disease

 Lung abscess, or empyema

 Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis

 Known or suspected bacteremia secondary to Staphylococcus aureus

 Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia

 Infection that necessitates the use of a concomitant antibacterial agent in addition to study medication [excluding subjects with concomitant use of long-term, low-dose macrolide for chronic respiratory diseases, sulbactam sodium/ampicillin sodium (Unasyn-S) and clindamycin (Dalacin-S)]

 Known bronchial obstruction or a history of post-obstructive pneumonia

 Known primary lung cancer


Interleukin-1 Trap to Treat Autoinflammatory Diseases

Summary: Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in several of these diseases. This exploratory study aims to examine the utility of the experimental drug candidate, IL 1 Trap (Regeneron Pharmaceuticals, Inc.) in the treatment of adult subjects with the autoinflammatory disorders Neonatal Onset Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), and Familial Cold Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF), and adult Still's disease. FMF is associated with mutations in pyrin encoding MEFV. NOMID, MWS and FCAS are associated with mutations in cryopyrin-encoding CIAS1.~This pilot study is designed to address: 1) the utility of IL 1 Trap in the treatment of subjects with diseases known to respond to IL-1 blockade (NOMID/MWS/FCAS) as shown by response to treatment with anakinra [Kineret]; 2) the response to IL-1 blockade of subjects with Adult Still's disease and colchicine-resistant FMF once the efficacy of IL-1 Trap has been established in NOMID/MWS/FCAS subjects; and 3) the biochemistry and genetics of autoinflammatory diseases and IL-1 related inflammation.~IL-1 Trap is a recombinant fusion protein with picomolar affinity for IL-1 and a half-life of approximately 7.5 days in humans. This agent is currently in Phase 2 clinical studies for the treatment of rheumatoid arthritis and initial studies have shown activity against clinical and biochemical indicators of inflammation. Compared with anakinra, this agent may exhibit improved dosing convenience, potential for fewer injection site reactions, and improved efficacy due to the extremely high affinity of IL-1Trap for its target.~In this study, biochemical, genetic, and clinical correlates of autoinflammatory disease will initially be measured at baseline following a withdrawal of any TNF or IL-1 inhibitor medications where applicable. Subjects will receive a course of therapy with IL-1 Trap that is predicted to provide an estimated 3-4 weeks of anti-inflammatory activity. Clinical, biochemical, and genetic correlates of inflammation will be measured at appropriate intervals to ascertain response and to further elucidate disease mechanisms. Subjects will be eligible, based on clinical response, to enter a 1- year extension phase with IL-1 Trap. Those subjects who complete the 1-year extension phase, and maintain improved clinical and laboratory parameters compared to baseline values, may continue to receive study medication at their current dose until the study drug is commercially available.~Investigator comment:~This protocol (from the NIH standpoint) is a continuation of the ongoing protocol 05-AR-0014, with a new change in study sponsor, the NIH replacing Regeneron as sponsor. this protocol therefore still contains background and procedural information that refer to patients with FMF and FCAS and or MWS and Still's disease, however only patients with Still's disease will be newly enrolled from this point on, enrollment for the FCAS and or MWS patients has already been completed and it has been decided to not enroll any more FMF patients because the number of subjects is too low to reach reasonable conclusions, in addition it has been difficult to recruit patients that are eligible. The background section and study procedures have largely been left as in the currently IRB approved protocol.
Inclusion criteria: inclusion criteria:

 Male or female subjects with inflammatory disease greater than or equal to 18 years of age.

 Participation in NIH study number 94-AR-0105 (Genetics and Pathophysiology of FMF and Related Disorders)

 Subjects presenting with active NOMID, MWS, FCAS, FMF, or adult Still's disease based on clinical signs/symptoms and/or biochemical markers such as acute phase reactants (CRP, SAA or ESR). Subjects need not have both clinical features and biochemical markers of disease to be enrolled. However, both clinical and laboratory responses will be evaluated in each subject for improvement as outcome measures (even improvement of laboratory values found to be within the normal range at baseline).

 NOMID, MWS, and FCAS: Diagnosis will be based on the history of classical features of disease including fevers, rash, joint involvement, CNS involvement. Approximately half of all subjects with these clinical syndromes are mutation negative; however, in the experience of the principal investigator these subjects show favorable clinical response to IL-1 blockade with anakinra. Therefore, subjects with or without recognized mutations in CIAS1 will be eligible to enroll in this study. Active disease will be defined as either the presence of aforementioned classical features, or a history of such features that became quiescent in the setting of therapy with anakinra. However, before a patient who has quiescent disease and is currently taking anakinra can receive study drug, he/she must fulfill criteria for active disease after anakinra has been discontinued.

 FMF will be diagnosed on the basis of documented presence of one or two mutant alleles of MEFV as well as the history of classical clinical features of FMF such as periodic fevers, rash, arthritis, arthralgia, or episodes of serositis. Subjects must be considered non-responsive to colchicine (up to 2 milligrams per day) on the basis of continued symptoms or flares (greater than or equal to one per month) or elevated acute phase reactants (ESR, CRP or SAA greater than or equal to 1.5 times the upper limit of normal between attacks) despite treatment with maximally tolerated doses of colchicine. Positive genetic test will be required for FMF to rule out the possibility that non-response to colchicine is due to misdiagnosis.

 Adult Still's disease will be diagnosed on the basis of history of classical clinical features such as fevers, evanescent salmon-pink rash, arthritis, arthralgia, and myalgia. Active disease will be defined as presence of one or more of these features and/ or elevation of acute phase reactants (ESR, CRP or SAA greater than or equal to 1.5 times the upper limit of normal).

 Subjects currently treated with anakinra may be enrolled in this study even though autoinflammatory disease may be quiescent. For these subjects a history of active autoinflammatory disease prior to treatment with anakinra will be sufficient. Subjects must be greater than 48 hours from their last dose of anakinra before beginning IL-1 Trap therapy, and will not take anakinra for the remainder of their enrollment in the study. However, before study drug is administered subjects have to manifest signs of active disease as described above

 Stable dose of steroids, NSAIDs, DMARDs, or colchicine for four weeks prior to enrollment visit.

 Females of childbearing potential (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at screening and a negative serum pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication.

 Women of childbearing age and men able to father a child, who are sexually active, who agree to use a form of effective birth control, including abstinence.

 Negative PPD test using 5 T.U. intradermal testing per CDC guidelines, and no evidence of active TB on chest X-ray. Subjects with latent TB (positive PPD test) currently treated with adequate therapy initiated for at least one month prior to first dose of study medication may be included. Full prophylaxis regimens will be completed. Subjects who have been BCG-vaccinated will also be skin-tested.

 Able to understand, and complete study-related questionnaires.

 Able and willing to give informed consent and abide with the study procedures.

Exclusion criteria: :

 Treatment with a live virus vaccine during 3 months prior to baseline visit. No live vaccines will be allowed throughout the course of this study.

 Current treatment with TNF inhibitors or recent discontinuation of TNF inhibitors (use within less than 5 half-lives of TNF inhibitor agent).

 Presence of active infections or a history of pulmonary TB infection with or without documented adequate therapy. Subjects with current active TB, or recent close exposure to an individual with active TB are excluded from the study.

 Chest x-ray read by a radiologist with pleural scarring and/or calcified granuloma consistent with prior TB.

 Positive test for or prior history of HIV, Hepatitis B or C.

 History or concomitant diagnosis of congestive heart failure.

 History of malignancy. Subjects deemed cured of superficial malignancies such as cutaneous basal or squamous cell carcinomas, or in situ cervical cancer may be enrolled.

 Known hypersensitivity to CHO cell derived biologicals or any components of IL 1 Trap.

 Presence of any additional rheumatic disease or significant systemic disease. For example, major chronic infectious/ inflammatory/ immunologic disease (such as inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, SLE in addition to autoinflammatory disease).

 Presence of any of the following laboratory abnormalities at enrollment visit: creatinine greater than 1.5 times the upper limit of normal, WBC less than 3.6 x 10(9)/mm(3); platelet count less than 150,000 mm(3); ALT or AST greater than 2.0 x ULN (ALT/AST greater than 2.0 x ULN in an adult Still's disease patient would prompt a hepatology consult prior to enrollment unless these abnormalities are considered by the Principal Investigator to be reflective of the underlying Still's disease).

 Lactating females or pregnant females.

 Subjects with asthma not adequately controlled on current therapy.

 Enrollment in any other investigational treatment study or use of an investigational agent, or has not yet completed at least 4 weeks or 5 half-lives, whichever is longer, since ending another investigational device or drug trial.

 Subjects for whom there is concern about compliance with the protocol procedures.

 Presence of other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

['Inflammation', 'Familial Mediterranean Fever', "Still's Disease, Adult-Onset"]

Inflammation
Familial Mediterranean Fever
Still's Disease
Adult-Onset


Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Summary: The purpose of this study is to evaluate the production of antibodies to a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135) polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also evaluate the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine. The hypothesis is that the test vaccine is comparable to the licensed active control vaccine.
Inclusion criteria: inclusion criteria (IC):

 Participant is willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explained.

 Male or female, aged 18 to 55 years old

 In general good health with no significant chronic or acute conditions that would interfere with immune response or expected Adverse Event (AE) evaluation in the opinion of the investigator as determined by Medical history and/or History-directed physical examination

 Abstinence or use of effective contraception by the participants or their partners during the trial and continuing for four weeks after vaccination will be required for males or female participants of child bearing potential.

 Able (in the opinion of the investigator) to comply with all study requirements.

Exclusion criteria:  (EC):

 Unwilling or unable to understand study requirements and give written informed consent for the study.

 Prisoners.

 History of Guillain-Barré syndrome (GBS).

 Pregnancy (confirmed by positive pregnancy test) or lactation.

 Previous diagnosis of laboratory confirmed meningococcal disease.

 Previous meningococcal meningitis vaccination in the last five years

 Laboratory abnormalities that are considered Grade 2 or higher (based on AE, ranges as described in the protocol appendix) that in the opinion of the Investigator would raise safety concerns for participation in the study or interfere with evaluation of study objectives, or abnormalities >2 times the Upper Limit of Normal range (ULN).

 Known or suspected autoimmune or connective tissue disorders, including rheumatoid arthritis and congenital or acquired immunodeficiency. Does not include mild to moderate seasonal/perennial allergies treated with over the counter antihistamines.

 Use of systemic immunosuppressive drugs or therapy within 6 months prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents. Includes anti-cancer chemotherapy, radiation, and long term systemic corticosteroid therapy. History of anaphylactic shock, severe asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination or known hypersensitivity to any vaccine component.

 Received blood, blood products, plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months.

 Use of systemic antibiotics within 72 hours prior to study enrollment.

 History of cirrhosis or hepatitis.

 Known bleeding disorder or condition associated with a prolonged bleeding time.

 Positive results of testing for hepatitis B surface antigen (HepBsAg), Hepatitis C or HIV-1 or HIV-2 antibodies. Known or suspected HIV or Hepatitis B or C infection.

 Positive results of drug screen that cannot be explained by use of approved prescription medication (amphetamine, tetrahydrocannabinol (THC), cocaine). Current (past 30 days) heavy smokers (greater than or equal 1 pack per day).tetrahydrocannabinol

 Received another investigational product within the last 30 days. Investigational product may be a drug, vaccine, medical device or medical procedure.

 History of significant head trauma, alcohol or substance abuse or other medical illnesses that could cause a neurological deficit (e.g., cerebro-vascular disease).

 Medication or alcohol use that, in the opinion of the Investigator, may influence or bias the clinical outcome of the trial.

 History of any serious chronic medical or psychiatric illnesses or condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

 History of chronic or severe headaches, myalgia, arthralgia, malaise, fatigue or other systemic disorder commonly observed as AEs for licensed meningococcal vaccines.

 Currently experiencing a cold, flu or other acute illness (subject may be deferred until after recovery).

['Meningococcal Meningitis', 'Meningococcal Infections']

Meningococcal Meningitis
Meningococcal Infections


Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide

Summary: The purpose of this study is to find the highest dose of mebendazole (MBZ) that can be safely given to people with malignant brain tumors in combination with the current standard of care (temozolomide) without causing severe side effects. We also want to find out if MBZ can slow the growth of the brain tumor. The study doctors have found that MBZ is effective against malignant brain tumors in the laboratory and animal models of brain tumors.
Inclusion criteria: inclusion criteria:

 Patients must have histologically confirmed newly diagnosed high-grade glioma(WHO Grade III or IV)

 Age ≥18 years

 Karnofsky Performance Score (KPS) ≥ 60%

 Life expectancy greater than 12 weeks

 Patients must have adequate organ and marrow function

 Completed >80% of the prescribed radiation therapy and concurrent temozolomide according to the Stupp regimen without grade 3 or 4 hematologic toxicity

 Patients may have received Gliadel during surgery

 Ability to swallow pills and keep medication record

 women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation.

 Ability to understand and willingness to sign a written informed consent document

 Be able to comply with treatment plan, study procedures and follow-up examinations

Exclusion criteria: :

 Patients must not have received prior therapy other than standard chemoradiation according to Stupp et al and Gliadel.

 Patients may not be receiving any other investigational agents while on study

 Patients who have known allergy to mebendazole or benzimidazole

 Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection

 Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy

 Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months

 Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.)

 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic hepatitis, acute hepatitis, or psychiatric illness/social situation that would limit compliance with study requirements

 Pregnant women are excluded

 Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis

 Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results

 Patients who are not available for follow-up assessments or unable to comply with study requirements


Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access

Summary: Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in femoral venous access site and reducing the incidence of complications associated with traditional closure methods. Furthermore, there are predictive factors(such as sheath size, obesity, procedure duration, and anticoagulation status)that we can use to assess the procedure's likelihood of success in various patients.
Inclusion criteria: inclusion criteria:

 All consented pts. over the age of 18 who received sutured mediated femoral vein following catheterization

Exclusion criteria: :

 Pt.s who are unable to give consent.

 Pts. whose participation in research is contraindicated for medical reasons are excluded.


Effect of Sevoflurane, Propofol and Dexmedetomidine on Delirium & Neuroinflammation in Mechanically Ventilated Patients

Summary: Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical course of delirium, SIRS and neuroinflammation in mechanically ventilated patients using CAM-ICU scale, GSK-3beta and protein S100b in serum.
Inclusion criteria: inclusion criteria:

 presence of delirium

Exclusion criteria: :

 presence of Alzheimer's disease

 any mental disorder

 presence of cancer


Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

Summary: The purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation.
Inclusion criteria: inclusion criteria:

 ASA physical status I-II, aged between 20 and 70 years

 scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation

Exclusion criteria: :

 recent respiratory tract infection or sore throat

 who were using analgesics or steroid preoperatively

 who have risk factors for oral cavity infection

 the surgical duration < 60 minutes or > 300 minutes

['triamcinolone acetonide', 'chlorhexidine gluconate']

triamcinolone acetonide
chlorhexidine gluconate


Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Summary: Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies.~Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many cases.~The aim of this study is to evaluate the usefulness of interferon-gamma release assay in addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.
Inclusion criteria: inclusion criteria:

 Age> 18 years

 in patients with solitary pulmonary nodule

 who had percutaneous needle biopsy for diagnosis of lung nodule

Exclusion criteria: :

 patients who do not agree the study enrollment


China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients

Summary: Stress ulcers or stress-related mucosal disease (SRMD) is defined as acute superficial inflammation lesions of the gastric mucosa induced when an individual is subject to abnormally elevated physiologic demands.[1] Studies have shown that SRMD occurred in 75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication in critically ill patients. The frequency of clinically important bleeding ranged from 5.3% to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely used in China current clinical practice for the prevention of stress ulcer bleeding. However, there is no epidemiology data to show the risk factors for stress ulcer bleeding and the bleeding rate of Chinese neurosurgical critically ill patients who are usually suffering from brain trauma, cerebral haemorrhage or brain tumour operation. Information is needed to know about the characteristics in Chinese critically ill neurosurgical patients.~Objectives of this Non-Interventional Study Primary~Primary objective: To estimate the overall incidence of upper gastrointestinal (GI) bleeding in critically ill neurosurgical patients in China.~Main secondary objective~To estimate the incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients in China.~To estimate the incidence of any overt upper GI bleeding without clinically significant complications in critically ill neurosurgical patients in China.~To assess time to upper GI bleeding after a cerebral lesion.~To investigate potential risk factors associated with upper GI bleeding, and assess how common certain risk factors occurred in upper GI bleeding patients.~To assess the overall incidence of upper GI bleeding in critically ill patients by different risk factors for upper GI bleeding.~To investigate the drugs, the route of administration, the doses and the duration commonly used for stress ulcer prophylaxis.~To investigate the proportion of ICU patients with nasogastric tube, and the duration of nasogastric tube.~(ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)
Inclusion criteria: inclusion criteria:

 The subject population that will be included in the NIS are the consecutive discharged patients ≥18 years old who were hospitalized to Neurosurgical departments. Those whose Glasgow Coma Scale (GCS) ≤10[4] within 24 hours of lesion/admission will be defined as critically ill patients. Three kinds of cases will be included: brain trauma critically ill patients, cerebral haemorrhage critically ill patients or postoperative brain tumour critically ill patients.

Exclusion criteria: :

 If participating in any clinical trial, the subject cannot take part in this study. Subjects are ineligible if they have below conditions:

 Those who were likely to swallow blood (for example, those with severe facial trauma or epistaxis;

 Patients with previous total gastrectomy;

 Known upper GI lesions that might bleed (e.g., varices, polyps, tumours, etc);

 Evidence of active GI bleeding including oesophageal and gastric variceal bleeding, Peptic Ulcer Disease (PUD)

['Stress Ulcers', 'Stress-related Mucosal Disease (SRMD)']

Stress Ulcers
Stress-related Mucosal Disease (SRMD)


Sleeve Gastrectomy Versus Gastric Bypass for Private Pay Patients Seeking Obesity Surgery

Summary: The purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery than the gastric bypass, gives similar weight losses and that the safety of gastric in private pay patients versus insurance patients will be similar. This is a retrospective chart review of intervention charts.
Inclusion criteria: inclusion criteria:

 The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic sleeve gastrectomy.

 The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic gastric bypass.

Exclusion criteria: :

 Subjects having any other obesity surgical procedure

['Laparoscopic Sleeve Gastrectomy', 'Laparoscopic Gastric Bypass']

Laparoscopic Sleeve Gastrectomy
Laparoscopic Gastric Bypass


Ketamine for Suicidality in Bipolar Depression

Summary: This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression.~The first drug, ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.
Inclusion criteria: inclusion criteria:

 Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation.

 Moderate to severe suicidal ideation

 18-65 years old

 Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment.

 Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills

 Able to provide informed consent

 Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening

Exclusion criteria: :

 Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness

 Significant ECG abnormality

 Pregnancy and/or lactation

 Current psychotic symptoms

 Contraindication to any study treatment

 Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal

 Inadequate understanding of English

 Prior ineffective trial of or adverse reaction to ketamine or midazolam

 Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion

['Suicidal Ideation', 'Bipolar Disorder', 'Major Depressive Episode']

Suicidal Ideation
Bipolar Disorder
Major Depressive Episode


Histopathological Diagnosis of Adenomyosis

Summary: The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy for diagnosing adenomyosis.
Inclusion criteria: inclusion criteria:

 females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic pain, menorrhagia, metrorrhagia

Exclusion criteria: :

 refusal of the patient to get enrolled in the study

['hysteroscopic endo-myometrial biopsy', 'ultrasound']

hysteroscopic endo-myometrial biopsy
ultrasound


Randomized Population-Based Study on Chlamydia Trachomatis Screening

Summary: 30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.~The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.
Inclusion criteria: inclusion criteria:

 born in 1974, 1974 or 1976 AND living in Aarhus County October 1007

Exclusion criteria: :

 -

['Screening for urogenital Chlamydia trachomatis']

['Chlamydia Trachomatis', 'Infertility', 'Ectopic Pregnancy']

Chlamydia Trachomatis
Infertility
Ectopic Pregnancy