Relationship of Gestational Age and Urine Concentration of S100B in Preterm and Term Infants in the First Week of Life

Summary: S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS) and is increased in CSF and blood after CNS injury. There are two objectives to this study. 1) To complement our previous study, is urine S100B concentration correlated with gestational age in infants born at > 28 weeks gestation during the first week of life? 2) Is the urine concentration of S100B affected by intracranial pathology in this gestational age range? Elevation of urine concentration of S100B may be an indicator that the infant will develop serious intracranial pathology and may allow for early initiation of treatment to potentially decrease morbidity.
Inclusion criteria: inclusion criteria:

 Infants born at >28 weeks gestation will be eligible for enrollment in this study.

Exclusion criteria: :

 Infants with fetal malformations, chromosomal anomalies, clinically significant sepsis (retractable hypotension, neutropenia, and thrombocytopenia), or no urine output for the first 48 hours will be excluded.


Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock

Summary: The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and effective intervention to prevent the development of inflammation and coagulopathy in trauma patients with hemorrhagic shock.
Inclusion criteria: inclusion criteria:

 Age ≥16 years of age or estimated weight ≥50kgs if age is unknown;

 Victim of blunt or penetrating trauma

 Hemorrhagic shock defined as:

 One or more episodes of systolic blood pressure ≤90mmHg at any time prior to enrollment into the study;

 An identified source of blood loss (abdomen, chest, pelvis/retroperitoneum, extremities, external) or

 Blood products (RBC, Platelets, Plasma, etc.) has been ordered to the trauma room.

 Admitted to St. Michael's Hospital directly from the scene of injury within 3 hours of the injury

 Application and completion of Remote Ischemic Conditioning (RIC) within 4 hours of the injury

Exclusion criteria: :

 Pregnancy

 Non-hemorrhagic shock (i.e. tension pneumothorax, cardiac tamponade, spinal shock, etc.)

 Major burns > 20% total body surface area

 Fracture of both lower extremities (i.e. traumatic amputation, fractures)

 Absence of vital signs prior to admission, ongoing CPR, possibly dead on admission or not expected to survive beyond a few hours.

 Injury in both legs (traumatic amputation, fractures, etc.)

 Patients with a systolic blood pressure above 200mmHg

 Patients treated with anticoagulants, antiplatelet therapy (Warfarin, Aspirin), steroids or with a known bleeding disorder or known abnormality of blood flow to the limb (if known)

 Patients with osteoporosis or other bone disorders, peripheral nerve injury, abnormal nerve supply, peripheral neuropathy (if known) or preexisting traumatic injury to the limb.

 Morbid obesity (largest cuff size won't fit)

 If RIC is done clinically before research protocol begins.


PiA: Prognosis Used Every Day for Patients With Operable Breast Cancer - Comparison of Invasion Factors uPA/PAI-1 With Other Prognostic Factors

Summary: The improvement of the healing rates for breast cancer is based to an important part on the consistent use of so-called adjuvant (supporting ) medicamentous therapies, including chemotherapy. However this success has a price due to still inaccurate knowledge of the individual risk of relapse: a high number of unnecessary therapies are applied (over-therapy!). The invasion factors uPA (plasminogen activator of the urokinase type) and PAI-1 (uPA inhibitor) were described extensively as strong and independent prognosis factors with high clinical relevance for patients with node negative breast cancer. Compared to clinical and pathological factors (further: traditional factors ) they show better estimation of the relapse risk leading to an avoidance of redundant adjuvant chemotherapy and may thus essentially contribute to the improvement of the quality of life in these women. In this study we aim to evaluate, how large the portion of the patients with early, operable, node negative breast cancer will be, in whom, by improved low-risk identification through uPA/PAI-1, adjuvant chemotherapy can be omitted.
Inclusion criteria: inclusion criteria:

 newly diagnosed breast cancer

 no metastasis detected

 operation for breast cancer

 female patient

 unilateral breast cancer

 informed consent given

 age min. 18 yrs.

Exclusion criteria: :

 metastasis of breast cancer

 bilateral breast cancer

 other cancer within the last 5yrs


Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

Summary: This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.
Inclusion criteria: inclusion criteria:

 Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas

 Tumor must be surgically resectable

 ECOG Performance Status of 0 to 1

 Adequate organ function as defined by study-specified laboratory tests

 Must agree to use acceptable form of birth control

Exclusion criteria: :

 Received any type of anti-cancer treatment or immunotherapy for pancreas cancer

 History of autoimmune disease (Graves or Hashimoto's disease, vitiligo, and type I diabetes are allowed)

 Systemically steroid use within 14 days

 Evidence of active infection

 Pregnant or lactating

 Diagnosed with another cancer or myeloproliferative disorder (some exceptions)

 History of severe hypersensitivity reaction to any monoclonal antibody or known component of the study drugs

 Known history of infection with HIV, hepatitis B, or hepatitis C

 Oxygen saturation of <92% on room air by pulse oximetry

 On home oxygen

['Cyclophosphamide', 'GVAX pancreatic cancer', 'Nivolumab', 'Urelumab', 'BMS-986253']

Cyclophosphamide
GVAX pancreatic cancer
Nivolumab
Urelumab
BMS-986253


Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

Summary: This study will investigate safety and reactogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children
Inclusion criteria: inclusion criteria:

 Infants of either sex, aged 16 - 20 months / 2 - 4 months

 in good health as determined by: medical history physical examination clinical judgment of the investigator;

 available for all visits scheduled in the study and able to comply with all study regulations;

 written informed consent obtained, from at least one parent or legal guardian

Exclusion criteria: :

 parent or legal guardian is unwilling or unable to give written informed consent to participate in study;

 infants who presented a previous disease potentially related to Haemophilus influenzae type b;

 infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease;

 infants who have received any other Haemophilus influenzae type b immunization dose before (for 16-20 months old children who have received a booster vaccination already);

 premature (before 37th week of gestation) or birth weight less than 2500 g;

 history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;

 fever ≥38.0 °C (axillary body temperature) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;

 subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease;

 known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;

 subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder;

 subjects with a clinically significant genetic anomaly;

 treatment with corticosteroids or other immunosuppressive drugs;

 treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months);

 any vaccination administered within 2 weeks (14 days) before enrollment;

 participation in any other investigational trial simultaneously;

 planned surgery during the study period;

 any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective


Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure

Summary: Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.
Inclusion criteria: inclusion criteria:

 Singleton pregnancy

 Term (> 37 weeks) pregnancy

 Cervical dilatation < 4 cm

 Kerr incision

 Age > 18 years old

Exclusion criteria: :

 Being in active phase of labor

 Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa )

 Having a history of uterine surgery (myomectomy, hysterotomy) other than CS

 Extension of Kerr incision

 Multiple pregnancy

 Maternal diabetes mellitus

 Maternal connective tissue disease

 Uterine malformation

 Uterine fibroids on Kerr incision line

 Chorioamnionitis

['Purse string closure technique', 'Continuously locked closure technique']

Purse string closure technique
Continuously locked closure technique

['Cesarean Section; Complications', 'Placenta Previa', 'Placenta Accreta']

Cesarean Section; Complications
Placenta Previa
Placenta Accreta


Granzymes and Perforin at the Onset of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Summary: COPD exacerbations are characterized by an excessive accumulation and activation of inflammatory cells in the airways. It is not known whether this phenomenon represents a risk for for lung damage via the release in the extracellular environment of potent cytolitic cellular granular contents such as granzymes and perforin.~The investigators assess the intracellular expression of granzymes and perforin in neutrophils and large granular lymphocytes (LGL) at the onset of exacerbations compared to stable disease.~The investigators hypothesize that a greater release of intracellular perforin and granzymes from neutrophils and LGL into the extracellular environment occur at exacerbations compared to stable condition and that these changes are more pronounced in COPD patients than in subjects without COPD who undergo respiratory infection.
Inclusion criteria: COPD patients

 inclusion criteria:

 All COPD patients who seek medical assistance at the clinic during the study period will be asked about COPD exacerbation related symptoms-medical history and then they will be included in the study if they satisfied all the following criteria:

 COPD diagnosis according to the GOLD Consensus Statement

 initiation of symptoms diagnostic for COPD exacerbation in the past 72 hours

 abstention from any new therapeutic intervention

 absence of any signs suggestive of severe exacerbation requiring hospitalization

 Control subjects

 inclusion criteria:

 Subjects who seek medical assistance at respiratory clinic for symptoms suggesting acute bronchitis (dyspnea, sputum production, purulence, wheeze, cough)

 medical history free of COPD, Asthma, pneumonia, other chronic respiratory disease or congestive cardiac failure,

 initiation of symptoms in the past 72 hours,

 abstention from any new therapeutic intervention, and

 absence of any signs suggestive of clinical condition requiring hospitalization.

Exclusion criteria: :

 Patients with Asthma or other respiratory disease will be excluded from this study

['Chronic Obstructive Pulmonary Disease']


Compass - Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia

Summary: Compass is a randomised controlled trial of primary HPV testing for cervical cancer screening in Australia. A pilot study involving 5,000 women was carried out in 2013-2014. The trial will involve recruiting 76,300 women from primary health clinics. Women aged 25-69, attending for cervical screening or for routine follow-up will be invited to participate in the 2-arm trial. A liquid-based cytology (LBC) sample will be taken from consenting women and sent to VCS Pathology. Women will be randomised in a 1:2 parallel group allocation to LBC and HPV arms using randomisation with the minimisation procedure, with stratification by birth cohort according to whether offered HPV vaccination in Australia's national publicly-funded HPV vaccination program (date of birth >=July 1st 1980 and <1st July 1980). In the LBC (active control) arm, women will undergo 2.5 yearly image read cytology screening with reflex HPV triage testing for low grade cytology. In the HPV (intervention) arm women will undergo 5 yearly HPV screening with partial genotyping enabling separate identification of HPV16 and HPV18 and referral of this group for diagnostic evaluation, and secondary randomisation of intermediate risk women testing positive for oncogenic HPV (but not HPV 16 or 18) to either image read LBC screening or dual-stained (DS) cytology testing with p16/Ki67. The laboratory reports issued to practitioners will specify the recommended management for women, according to study arm and test results.Participating women will be flagged and clinical outcomes will be tracked via the Compass Register. Data linkage between the Compass Register and HPV vaccination records held on the Australian Immunisation Register will be performed in order to integrate vaccination and screening histories for trial participants. Participants will be actively followed for an anticipated 5 years from the time of recruitment and the primary outcome is based on the total cumulative detection of CIN3+ after exit testing at 5 years. The anticipated study completion date of March 2027 takes into consideration the final migration of participants to the National Cancer Screening Register and allows for two years to follow-up any intermediate risk results occurring in the last of the recruited trial participants.
Inclusion criteria: inclusion criteria:

 Australian residents with a cervix, aged 25-69 years who are attending for routine cervical screening. (Note: since April 2016 recruitment has been confined to the younger strata, i.e. women age-eligible for HPV vaccination aged at least 25 and born on or after 1st July 1980, as the recruitment target of the older cohort was met).

 Participants may have been previously enrolled in the Compass Pilot but must have been discharged to routine screening. Women may also be in follow-up management for a previous abnormality or unsatisfactory cytology.

Exclusion criteria: :

 Previous total hysterectomy (uterus and cervix).

 The presence of symptoms or signs for which cervical cancer must be excluded.

 Currently undergoing treatment for cervical cancer.

 Currently enrolled in the Compass Pilot Study.

['Molecular testing for HPV', 'Liquid Based Cytology']

Molecular testing for HPV
Liquid Based Cytology

['Cancer of the Cervix', 'Cervical Intraepithelial Neoplasia']

Cancer of the Cervix
Cervical Intraepithelial Neoplasia


Effectiveness of SisterTalk Hartford for Weight Loss Among African-American Women

Summary: The purpose of the SisterTalk Hartford study was to assess whether a theoretically- and scientifically-based, culturally acceptable weight loss program could be effectively translated into a faith-based program and subsequently delivered in the church to help African-American women lose weight.
Inclusion criteria: inclusion criteria:

 BMI of at least 25.0

 self-identifies as Black or African-American

 able to do mild physical activity such as walking or chair exercises

Exclusion criteria: :

 has insulin dependent diabetes

 is pregnant, nursing, or had a baby in the past 4 months

 has ever been treated for an eating disorder (e.g. anorexia nervosa, bulimia)

 had a heart attack in the past 2 years requiring hospitalization

 has ever had a stroke

 has congestive heart failure

 has uncontrolled hypertension

 currently participating in another study

 is on a doctor-prescribed diet that cannot be changed (e.g. very low protein diet for a person in liver failure)

['SisterTalk Hartford', 'Attention control video series']

SisterTalk Hartford
Attention control video series


Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy

Summary: RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether gefitinib is more effective than a placebo in treating esophageal cancer.~PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared with a placebo in treating patients with esophageal cancer that is progressing after chemotherapy.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically confirmed esophageal cancer or gastroesophageal junction tumor including the following subtypes:

 Adenocarcinoma

 Squamous cell cancer

 Poorly differentiated epithelial malignancy

 Gastroesophageal junction with Siewert type I or II tumors

 Failure after no more than 2 prior chemotherapy regimens and 1 chemoradiation course

 Measurable or evaluable disease by CT scan

 Patients with brain metastases must be stable and have received cranial irradiation prior to entry

 PATIENT CHARACTERISTICS:

 WHO performance status 0-2

 Serum bilirubin ≤ 3 times the upper limit of normal (ULN)

 AST/ALT ≤ 2.5 times ULN (≤ 5 x in presence of liver metastases)

 Able to take oral tablets (whole or dispersed)

 No evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic allowed)

 No known severe hypersensitivity to gefitinib or any of the excipients of this product

 No prior other malignancy likely to confound results or interfere with gefitinib therapy

 No medical condition considered to interfere with the safe participation in the trial

 Not pregnant

 Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 See Disease Characteristics

 No chemotherapy (including oral) within the past 6 weeks

 No radiotherapy to site of measurable or evaluable disease within the past 4 weeks

 No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications
Exclusion criteria:

['Adenocarcinoma of the Gastroesophageal Junction', 'Esophageal Cancer']


Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children

Summary: The purpose of this study is to see if the surgical safety checklist is associated with a reduction in perioperative complications for children undergoing surgery in Ontario, Canada.
Inclusion criteria: inclusion criteria:

 Surgical admission, with a noncardiac surgical interventions

 Aged between >28 days and <18years on the day of the surgical intervention

Exclusion criteria: :

 Non-surgical admission

 Surgical interventions with <10 per group

 Cardio-thoracic and interventional cardiology procedures

['Intraoperative Complications', 'Postoperative Complications']

Intraoperative Complications
Postoperative Complications


Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

Summary: Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of hypertension

 Clinical diagnosis of type 2 diabetes or impaired glucose tolerance

Exclusion criteria: :

 History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.

 Taking calcium channel blocker for the purpose of angina pectoris

 Reduced ejection fraction (< 40%)

 Second- or third-degree of atrioventricular block

 Severe hypertension (> 200/110 mmHg) or secondary hypertension

 History of stroke in the recent 6 months

 Serum creatinine > 2.5 mg/dl

 Estimated survival duration less than 3 years due to other conditions

 Pregnant woman or possibly pregnant woman

['Hypertension', 'Type 2 Diabetes Mellitus']


A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

Summary: This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.
Inclusion criteria: inclusion criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s)
Exclusion criteria: : - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)

['insulin degludec', 'insulin glargine']

['Diabetes', 'Diabetes Mellitus, Type 2']


Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography

Summary: The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we performed a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe).
Inclusion criteria: inclusion criteria:

 Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending.

 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease).

 Able to provide a written informed consent.

 <75 years of age, but >40 years of age.

 Able to hold breath for at least 10 seconds.

 Sinus rhythm.

Exclusion criteria: :

 New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block

 Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%])

 Greater than 6 hours since presentation to ED.

 BMI >40 kg/m2

 Impaired renal function as defined by serum creatinine >1.5 mg/dL*

 Elevated troponin-T (> 0.09 ng/ml)

 Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy)

 Known allergy to iodinated contrast agent

 Currently symptomatic asthma

 Documented or self-reported cocaine use within the past 48 hours (acute)

 On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan

 Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner

 Participant with no telephone or cell phone numbers or no address (preventing follow-up)

 Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan.

 Participant unwilling to provide a written informed consent.

['Acute Coronary Syndrome', 'Myocardial Infarction', 'Unstable Angina Pectoris']

Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina Pectoris


Early Selective TAE to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis

Summary: The aim of this study is to determine if early angiographic embolization can forestall recurrent bleeding in selected high risk ulcers after their initial endoscopic control; to validate prospectively the investigators proposed in selecting high risk ulcers for recurrent bleeding in spite of maximal endoscopic control and profound acid suppression using high dose intravenous infusion of proton pump inhibitor; to characterize the nature of bleeding arteries in severely bleeding peptic ulcers and determine the efficacy of angiographic embolization in the prevention of recurrent bleeding and to establish safety profile of angiographic embolization as an early elective treatment to bleeding peptic ulcers.
Inclusion criteria: inclusion criteria:

 Actively bleeding peptic ulcers (Forrest I), NBVV or Forrest IIa ulcer,

 Successful endoscopic hemostasis by combination treatment of injected epinephrine followed by either 3.2mm heat probe 30J (4 continuous pulses) or hemo-clipping (at least 2 clips) And one of the followings

 Spurting hemorrhage during endoscopy;

 Ulcer >= 2 cm is determined by an opened biopsy forceps;

 Hb on admission of < 9 g/dl; or

 Hypotension prior to endoscopy defined by SBP of <90 mmHg AND HR of >110 bmp

Exclusion criteria: :

 -

['Bleeding', 'Peptic Ulcer', 'Arterial Embolization']

Bleeding
Peptic Ulcer
Arterial Embolization


Lipid Profile in Patients With Severe Sepsis or Septic Shock Under Strict or Liberal Glycemic Control

Summary: Study of the lipid metabolism under glycemic control in septic patients who got an university 14 bed ICU.~Hypothesis: establish a relationship between lipid metabolism alterations and glycemic control or infusion of exogenous insulin
Inclusion criteria: inclusion criteria:

 all patients aged between 18 and 80 years old

 with the diagnostic of septic shock or severe sepsis

Exclusion criteria: :

 pregnants,

 previous diagnosis of any cancer,

 diagnosis of leptospirosis,

 diagnosis of aids.


Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure

Summary: It is still uncertain what the best treatment is for patients who have both atrial fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal treatment for patients with these two significant medical conditions. This will be performed by comparing two alternative strategies for AF management: catheter ablation (to restore normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal rhythm). After random assignment, the effect of each strategy will be assessed by looking for changes in exercise capacity, symptoms, heart pump function, and quality of life during 12 months of follow-up.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years, < 80years

 NYHA II-IV symptoms

 Impairment of left ventricular systolic function (left ventricular ejection fraction estimated as ≤ 35% by radionuclide ventriculography)

 Documented AF lasting for at least 7 days (persistent or permanent AF)

Exclusion criteria: :

 CRT or ICD device implanted in the previous 6 months

 AV nodal ablation within previous 3 months

 Prior AV nodal ablation or complete heart block with a single chamber pacemaker

 Contraindication to anticoagulation

 Persistent thrombus in the left atrium despite anticoagulation

 Active malignancy

 Cerebrovascular accident within the previous 6 months

 Reversible causes of AF including thyroid disorders, alcohol, recent surgery

 Reversible causes of heart failure including acute myocarditis or alcohol

 Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months

 Prior AF ablation procedure

 Previous heart transplant, or on urgent heart transplant waiting list

 Severe neuro-muscular disease

 Creatinine clearance <30 ml/min

 Serum bilirubin >50 micromol/L

 Active participation in another research study

 Unable to understand and comply with protocol or give written informed consent

 Body mass index >35 (kg/m2)

['Medication to control ventricular rate in AF', 'Catheter Ablation for Persistent Atrial Fibrillation']

['Atrial Fibrillation', 'Heart Failure']


Maintenance Therapies in Bipolar Disorders

Summary: The purpose of this study is to see if adding a regimen of individualized psychotherapy can help bipolar I patients who are on lithium.~While having a manic or depressed episode patients will be assigned randomly (like tossing a coin) to receive appropriate medication either with or without additional individual psychotherapy. If a patient responds well, he/she will again be assigned randomly to receive further preventative treatment in which medication will be managed either with continued medication clinic visits alone or with additional individual psychotherapy (the patient may not receive the same additional treatment this time). Patient response to treatment will be evaluated throughout the study. If manic/depressive symptoms return at any point during the study, the patient will be treated with appropriate medication and will continue the study.~An individual may be eligible for this study if he/she:~Has Bipolar I disorder, is experiencing a manic or depressed episode at the time of study entry, and is at least 18 years old.
Inclusion criteria: inclusion criteria:

 -

 Patients must have:

 Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry.

 -

 Required:

 Current treatment with lithium carbonate.
Exclusion criteria:

['Individual psychotherapy', 'Lithium carbonate']

Individual psychotherapy
Lithium carbonate


Chlorzoxazone in Hip and Knee Arthroplasty

Summary: The purpose of this study is to elucidate whether patients operated with THA and TKA can benefit from treatment with chlorzoxazone.
Inclusion criteria: inclusion criteria:

 Planned primary unilateral THA or TKA

 Patients (male/female) ≥ 18 år

 Patients giving written informed consent and authority.

 Patients receiving spinal anaesthesia

Exclusion criteria: :

 Patients with intolerance to trial medications

 Rejection of or contraindicated spinal anaesthesia

 Patients with rheumatoid arthritis.

 Patients with Body Mass Index (BMI) ≥ 35

 Patients that do not read or write Danish

['chlorzoxazone', 'Placebo', 'THA', 'TKA']

['Osteoarthritis of Hip', 'Osteoarthritis, Knee']

Osteoarthritis of Hip
Osteoarthritis
Knee


Intestinal Microbiota Composition After Antibiotic Treatment in Early Life

Summary: In this prospective observational cohort study the potential clinical consequences of antibiotic use in early life and perturbations in the gastrointestinal microbiota composition due to that antibiotic use are studied. It is hypothesized that altered microbiota may be an important underlying mechanism for impediments in the developing immune system.~Differentiation will be made between a group of neonates who received antibiotics in the first week of life, and control infants who were not exposed to antibiotics in the neonatal period.
Inclusion criteria: inclusion criteria:

 Term-born babies (≥ 36 weeks gestational age)

 (Short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment

 Signed informed consent by the parents

Exclusion criteria: :

 Congenital illness or malformations

 Severe perinatal infections for which transfer to the neonatal intensive care unit is needed

 Maternal probiotic use ≤ six weeks before delivery

 Insufficient knowledge of the Dutch language.


Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome

Summary: The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.
Inclusion criteria: inclusion criteria:

 Body mass index more than or equal to 25 kg/m2

 Patients with metabolic syndrome

 Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs.

Exclusion criteria: :

 Uncontrolled diabetes patients

 Patients with gastrointestinal abnormalities

 Patients with cardiovascular diseases

 Patients with hematologic disorders

 Patients with Glomerular filtration rate less than 60 ml/min/1.73m2

 Patients with drug or alcohol abuse

 Pregnancy and lactation

['meal replacement group', 'control group']


The Effect of Intravenous Lidocaine on Pain After Thyroidectomy

Summary: This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy.~A total 56 patients will be randomized into one of two groups(group C or group I) based on Excel number generation.~Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr.~Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.
Inclusion criteria: inclusion criteria:

 Total thyroidectomy

Exclusion criteria: :

 mental change

 allergy to local anesthetics

['Intravenous lidocaine injection', 'Intravenous normal saline injection']

Intravenous lidocaine injection
Intravenous normal saline injection

inclusion criteria:

 Total thyroidectomy


Revaccination With Pollinex® Quattro

Summary: The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex® Quattro as a short-term revaccination in patients who have already been successfully desensitized at least five years ago against grass-pollen but developed a recurrent allergy.
Inclusion criteria: inclusion criteria:

 Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen.

 A previous specific immunotherapy finished at least five years ago had to be successful.

Exclusion criteria: :

 Contraindications according to the patient information leaflet


Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain

Summary: The objectives of this trial are to investigate the efficacy and safety of six weeks of treatment with OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.
Inclusion criteria: inclusion criteria:

 Age 45 to 80 years old, inclusive

 Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) criteria:

 Knee Pain

 At least 1 of 3:

 Age > 50 years

 Morning stiffness lasting < 30 minutes

 Crepitus on motion

 Osteophytes on radiograph

 Symptoms associated with osteoarthritis of the knee (including pain) for ≥ 6 months prior to Screening

 Knee pain associated with osteoarthritis, which required NSAID or other therapy for ≥ 15 days during the preceding month

 Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 2 or 3 in the target knee (does not include borderline Grade 2), as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit. (Sharpening of the tibial spine is not considered to be an osteophyte) (See Appendix 4 for additional details)

 Meets pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System

 No clinically significant change in physical activity and/or therapy for the past 3 months

 Able to provide written informed consent prior to initiation of any clinical trial-related procedures; and willing and able, in the opinion of the Investigator, to comply with all requirements of the clinical trial for the duration of the trial (such requirements include, but are not limited to: attending all study visits, refraining from elective surgery or extensive travel during participation)

Exclusion criteria: :

 General

 Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if:

 They are or intend to become pregnant (including use of fertility drugs) during the study

 They are nursing

 They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.)

 Body Mass Index (BMI) over 40

 A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator

 Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization

 Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit

 Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02

 Pain Related

 Does not meet pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System

 Clinically significant joint (other than the knee) or general pain at Baseline, at the discretion of the Investigator

 Musculoskeletal Related

 Clinically significant, excessive effusion heat and/or redness in the target knee as determined by the Investigator

 Knock-kneed or bow-legged, as defined by a valgus or varus deformity of ≥ 15 degrees

 Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 0, 1 or 4 in the target knee, as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit (sharpening of the tibial spine is not considered to be an osteophyte)

 Documented history of clinically significant pain associated with osteoarthritis of the spine or hips, at the discretion of the Investigator

 Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia

 Clinically significant medio-lateral and/or anterior-posterior instability, at the discretion of the Investigator

 Open surgery of the target knee within the prior year or surgery to the contralateral knee or other weight-bearing joint within the prior year, if at the discretion of the Investigator it would interfere with the study. If subject had open surgery more than one-year prior, Sponsor's designated rheumatologist must confirm that such surgery did not have any negative impact or consequence to the target knee (e.g., deformity of angle to the bone, bone on bone, locking joints, etc.)

 Arthroscopic surgery of the target knee within the prior six months

 Any acute or chronic injury, other than osteoarthritis in the target knee, that will be treated during the trial with any medication not allowed during the Treatment Period

 Prior surgery of the target knee requiring insertion of a medical device or surgical hardware (e.g., screws)

 Any major trauma or injury (including sports injuries) to the target knee in the past 12 months

 Documented history of inflammatory joint disease, including but not limited to: rheumatoid arthritis, gout, pseudogout, Paget's disease, psoriatic arthritis, ankylosing spondylitis, chronic inflammatory disease (e.g., colitis), fibromyalgia (diagnosed in accordance with ACR criteria, as applicable), articular fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g., hypermobility) or collagen gene mutations

 Any planned interventional and/or surgical procedure during the 6-week Treatment Period following randomization

 Concomitant Conditions, Diseases, Medications/Therapies and Medical History Related

 Any use of Rescue Medication within 24 hours prior to the Baseline visit or use of any other pain medication within 7 days prior to Baseline visit

 Uncontrolled hypertension, defined as blood pressure ≥ 150/95 mmHg

 A history of uncontrolled and untreated diabetes mellitus with an HbA1c level > 8; or blood sugar levels that are outside of the normal range and HbA1c level > 8 is subsequently confirmed

 Any inflammatory skin condition over the target knee application area

 Use of any prohibited concomitant medications/therapies during the 7-day Washout Period or planned use of any prohibited concomitant medications/therapies during the 6 week Treatment Period

 Use of intraarticular or intramuscular steroids in the target knee within the previous 3 months or in any other joint within the previous 30 days

 Use of intraarticular hyaluronate in the target knee within the previous 6 months or in any other joint within the previous 30 days

 Current substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism and/or addiction to pain medications) that is determined at the discretion of the Investigator as likely to interfere with trial assessments or recur during the trial

 Use of any systemic (oral or parenteral) corticosteroids within the prior month

 Uncontrolled psychiatric conditions (e.g., mania, depression, anxiety, substance dependence of any kind) that would impair the subject from safely participating in the trial, including completing any protocol requirements

 Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average pain level in the past 24 hours

 Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological or neurological disease or prior surgery that may interfere with the subject successfully completing the trial, including completing any protocol requirements as determined by the Investigator

 History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)

 Diagnosed with any form of cancer within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin

 Any other medical conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing any protocol requirements

 Active infection within 3 days of the Baseline visit


Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?

Summary: Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves´thyrotoxicosis. The subject of this study is to investigate this
Inclusion criteria: inclusion criteria:

 New diagnose of autoimmune thyrotoxicosis

 biochemically proven with increased thyroxin

 low TSH and elevated TRAb/or positive scintigraphy.

 Age 18 - 55. Willing to participate -

Exclusion criteria: :

 No previous head trauma,

 No difficulties with swedish language,

 No medication which could affective neuropsychological testing,

 No planned or ongoing pregnancies.

 Normal intellectual capacity.

 No severe ophthalmopathy, or other severe disease

['QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis', 'Potential Effect of Selenium']


Heart Failure in the Community

Summary: To monitor trends in congestive heart failure in Olmsted County, Minnesota.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Heart Diseases', 'Heart Failure', 'Coronary Disease', 'Diabetes Mellitus', 'Hypertension', 'Obesity']

Cardiovascular Diseases
Heart Diseases
Heart Failure
Coronary Disease
Diabetes Mellitus
Hypertension
Obesity


Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan

Summary: This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.
Inclusion criteria: inclusion criteria:

 Postmenopausal women

 Age 50 years or greater

Exclusion criteria: :

 Previously diagnosed osteoporosis, or receiving treatment for osteoporosis


Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Summary: the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.
Inclusion criteria: inclusion criteria:

 Only healthy male volunteers in the 18-40 age range will be included.

 At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90

 The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.

Exclusion criteria: :

 Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.

 Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication

 History of hypersensitivity to sildenafil citrate or any components of its formulations

['Treatment A', 'Blood samples for the analysis of sildenafil in plasma', 'Treatment B', 'Blood samples for the analysis of sildenafil in plasma', 'Treatment C', 'Blood samples for the analysis of sildenafil in plasma']


To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients

Summary: This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia.~The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.
Inclusion criteria: inclusion criteria:

 Non-penetrating traumatic brain injury

 Glasgow Coma Scale (GCS) motor score ≤5 (not following commands)

 Estimated or known age 22-65 years

 Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury

 Estimated time of injury to time to reach temp of 35°C<6 hrs

Exclusion criteria: :

 Total GCS = 3 and bilateral fixed and dilated pupils

 Following commands after an initial period of coma (GSC motor score of 6)

 Known pre-existing neurological deficit (e.g., previous traumatic brain injury (TBI), stroke)

 Concomitant spinal cord injury

 Arrival temperature is <35°C

 Hemodynamic instability (i.e., mean arterial pressure (MAP)<60 millimetres of mercury (mmHg) for 30 minutes)

 Active cardiac dysrhythmia resulting in hemodynamic instability

 Pregnancy

 Duret hemorrhage

 Prisoner or Ward of the State

 Known history of clotting disorder (e.g., heparin induced thrombocytopenia, pulmonary embolism/deep venous thrombosis)

 Injury to other body organ where hypothermia would be precluded because of bleeding risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or international normalized ratio (INR) >1.4)

 Inability to obtain informed consent or utilize exception to informed consent for emergency research.

['Temperature management Zoll Intravascular Temperature Management device']


Use of Remote Ischaemic Preconditioning in the Prevention of Contrast Induced Nephropathy

Summary: With an increasingly ageing population the incidence of peripheral arterial disease (PAD) is rising. With approximately one quarter of all PAD patients ultimately progressing to Critical Limb Ischaemia (CLI), increased demands are being placed on vascular imaging to accurately assess stenotic lesions. Early infrainguinal lesions (i.e. TASC A & B) can be treated with angioplasty+/- stenting and accurate assessment relies on the imaging gold standard of angiography.~Patients with PAD often have concomitant co morbidities such as diabetes and chronic renal impairment placing them at increased risk of developing contrast induced nephropathy (CIN) when exposed to iodinated contrast media. High risk individuals with decreased eGFR <60ml/min have a risk of between 20-30% of developing CIN. They have increased morbidity and mortality risks with a greater need for dialysis and prolonged in patient hospital stays. Ideally, the investigators should be searching for ways to decrease the incidence of CIN. Animal studies and more recently pilot human trials have shown that subjecting a remote vascular bed to a brief ischaemic stress, followed by a period of reperfusion; in what has been termed remote ischemic preconditioning (RIPC), may confer a protective benefit against the development of CIN. This study aims to determine if RIPC can protect against CIN in patients undergoing elective peripheral angiography for infrainguinal disease.
Inclusion criteria: inclusion criteria:

 Elective intra-arterial peripheral angiography/angioplasty;

 Patients >21 years of age;

 Patients with CKD as evidenced by eGFR levels of 30ml/min < eGFR < 60ml/min (moderate risk) or eGFR levels of >= 60ml/min (low risk).

Exclusion criteria: :

 Severe renal impairment eGFR <30ml/min;

 Evidence of acute renal failure or patients on dialysis;

 History of previous CIN;

 Contraindication to volume replacement therapy;

 Pregnancy;

 Patients on glibenclamide or nicorandil (these medications may interfere with RIPC).

['Remote Ischaemic Preconditioning', 'Contrast Induced Nephropathy']

Remote Ischaemic Preconditioning
Contrast Induced Nephropathy


Impact of Size of Gastric Sleeve on the Weight Loss. Correlation With Gastric Function and Endocrine-metabolic Changes.

Summary: Morbid Obesity (MO) is considered the most important epidemic in the developed world in the twenty-first century. After initial assessment of morbidly obese patients and the exclusion of potentially correctable causes, management involves a combination of dietary changes, cognitive therapy, physical activity, psychological support and pharmacological treatment. However, any combination of these factors has proven long-term effectiveness in achieving significant and sustained reduction of excess weight. Currently, surgery is the only treatment capable of achieving this goal, interacting also with significant improvement in quality of life and overall long-term mortality.~In recent years, several authors have reported excellent short-term results with performing sleeve gastrectomy, but whether some aspects regarding the variability of gastric tubulization design could influence the results obtained in relation to weight loss and functional changes and gastric hormones.~The main objective of this study is to assess the size of the gastric tubulization (based probe calibration and the distance from the pylorus to which initiate gastric section) that can provide a better clinical outcome (such as excess weight loss) in patients undergoing surgery for morbid obesity. Secondary objectives were to assess the morphological changes, physiological and hormonal obtained according to the size of the gastric tubulization and its effect on weight loss patients.
Inclusion criteria: inclusion criteria:

 Age more than 18 years and less than 65 years

 BMI more than 40 kg/m2 or more than 35 kg/m2 with comorbidities likely to improve after weight loss.

 Morbid obesity established at least five years.

 Continued failures to adequately supervised conservative treatments

 Absence of endocrine disorders that are due to morbid obesity.

 Psychological stability:

 No alcohol or drug abuse.

 Absence of major psychiatric disorders (schizophrenia, psychosis), mental retardation, eating disorders (bulimia nervosa).

 Ability to understand the mechanisms to lose weight with surgery and understand that not always achieved good results.

 Understand that the goal of surgery is to achieve the ideal weight.

 Commitment for Adherence to surveillance guidelines after surgery

 Informed consent after receiving all the necessary information (oral and written).

 Women of childbearing age should avoid pregnancy for at least the first year after surgery

Exclusion criteria: :

 No acceptance

 Age less than 18 years or more than 65 years

 Previous bariatric surgery

 Previous gastric surgery

 Inflammatory bowel disease

['Bougie Size 33 Fr', 'Bougie Size 42 Fr', 'Distance pylorus 2 cm', 'Distance pylorus 5 cm']

Bougie Size 33 Fr
Bougie Size 42 Fr
Distance pylorus 2 cm
Distance pylorus 5 cm


Ketamine/Propofol vs Ketamine Alone for Pediatric Fracture Reduction

Summary: The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a double-blind, randomised, controlled trial in a paediatric emergency department. We believe that the combination of these two agents will provide a new and more effective option for procedural sedation in paediatric emergency department patients. The hypothesis of the study is that paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time, time to recovery, complications and improved satisfaction scores compared to patients receiving Ketamine alone.
Inclusion criteria: inclusion criteria:

 Healthy pediatric emergency patients with isolated extremity injury requiring reduction

Exclusion criteria: :

 Active respiratory illness

 Seizure disorder

 Craniofacial abnormalities

 Allergy to soy, ketamine, or propofol

 Hypertension

 Significant renal, cardiovascular or neurologic disease

['Ketamine only', 'Ketamine - Propofol']


Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women

Summary: The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.
Inclusion criteria: inclusion criteria:

 Pregnant women aged ≥18, gestational week ≥20, ≤33 at baseline visit with normal antenatal screening test results.

 Iron deficiency anaemia defined as Hb concentration ≥8 g/dl and ≤10.4 g/dL and serum ferritin ≤20 mcg/L at screening.

 Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study.

Exclusion criteria: :

 Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study.

 Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia.

 Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein >10 mg/dl or outside reference range), any acute infection at screening.

 Pre-eclampsia.

 Multiple pregnancy.

 Evidence on any significant abnormalities on anomaly ultrasound.

 Haemochromatosis or other iron storage disorders.

 Folate deficiency (S-folate <4.5 nmol/L) at screening.

 Vitamin B12 deficiency (S-cobalamin <145 pmol/L) at screening.

 Serious medical condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study.

 Known chronic renal failure (defined as creatinine clearance <30 mL/min calculated by Cockcroft-Gault or modification of diet in renal disease formula).

 Severe cardiovascular diseases.

 Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.

 Inability to fully comprehend and/or perform study procedures in the Investigator's opinion

 History of endocrine disorders

 Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia

 Recent significant bleeding/surgery (within the 3 months prior to screening).

 Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit at screening.

 Participation in any other interventional study since estimated conception and throughout study participation.

 Known hypersensitivity to FCM or other IV iron preparations.


Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid Tumours

Summary: The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors.
Inclusion criteria: inclusion criteria:

 Histologically or cytologically confirmed neuroblastoma, brain tumor or other solid tumor (at diagnosis)

 Relapsed or refractory tumors in which correct standard treatment approaches have failed

 No more than 2 lines of prior chemotherapy

 Measurable primary and/or metastatic disease on CT/MRI at least one bi-dimensionally measurable lesion.

 For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring.

 Age at inclusion: 6 months to ≤ 20 years

 Lansky play score ≥ 70% or ECOG performance status ≤ 1

 Life expectancy ≥ 3 months

 Adequate organ function:

 Adequate haematological function: haemoglobin ≥ 80 g/l, neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L; in case of bone marrow disease: neutrophils ≥ 0.5 x 109/l and platelets ≥ 75 x 109/l;

 Adequate renal function: normal creatinine related to patient's age:

 0 - 1 year: ≤ 40 µmol/L

 1 - 15 years: ≤ 65 µmol/L

 15 - 20 years: ≤ 110 µmol/L Adequate hepatic function: bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN (AST, ALT ≤5xULN in case of liver metastases)

 Wash-out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions). Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study.

 Patients previously treated with only one of the 2 drugs are eligible.

 Able to comply with scheduled follow-up and with management of toxicity.

 All patients with reproductive potential must practice an effective method of birth control while on study. Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment.

 Written informed consent from patient, parents or legal guardian.

Exclusion criteria: :

 Concurrent administration of any other anti-tumour therapy.

 Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study.

 History of allergic reaction to the compounds or their solvents.

 History of allergic reaction to Dacarbazine (DITC).

 Galactosemia, Glucose-galactose malabsorption or lactase deficiency.

 Pregnant or breast feeding young women.

 Presence of symptomatic brain metastases in patients with solid non-CNS tumors.

['Neuroblastoma', 'Brain Tumors', 'Solid Tumors']


Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors

Summary: By means of a prospective, randomised trial the investigators want to examine skin closure in living donors - subjected to laparoscopic, hand-assisted nephrectomy - by tissue glue (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1; 30 + 30 donors).~Study hypothesis: (i) Latest generation tissue glue (Cyanoacrylate (Liquiband)) is at least as good as conventional suture regarding wound healing/complications. (ii) Peroperatively, tissue glue is faster than conventional suture.
Inclusion criteria: inclusion criteria:

 Living kidney donor with informed consent

 Approved comprehensive work-up/evaluation at local hospital

Exclusion criteria: :

 Allergy towards acrylate or similar chemicals

 Unable to communicate in norwegian language

['Skin wound closure by tissue glue', 'Skin wound closure by conventional suture + dressing']

['Skin Closure of Surgical Incisions by Tissue Glue vs Suture']


A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women

Summary: The purpose of this trial is to study the efficacy and safety of low dose of estradiol valerate in the prevention and treatment of postmenopausal osteoporosis.
Inclusion criteria: inclusion criteria:

 All patients meet the criteria:

 Patients with informed consent.

 Breast Cancer inform possible danger.

 Physical and mental health.

 Menopausal transition meet the criteria:

 Age between 40

  55 years old.

 Women with Menopause syndrome or menstrual disorders.

 The second to fourth lumbar spine bone mineral density to normal.

 Early postmenopause meet the criteria:

 Age between 45

  60 years old.

 Spontaneous amenorrhea for more than six months and less than 5 years.

 The second to fourth lumbar spine bone mineral density was between -1 and -2.5 Standard deviation Compared with normal young women.

Exclusion criteria: :

 Tobacco or alcohol abuser.

 History of various malignant diseases.

 Women with Serious chronic diseases, such as liver and kidney dysfunction.

 Women Suffering from endocrine diseases, such as Thyroid disease, Parathyroid disease,Adrenal disease and Osteomalacia.

 Women with Long-term application of drugs, such as Antiepileptic drug, Adrenocorticotropic hormone, Diuretics and Heparin.

 Women had used estrogen or calcitonin in the past 6 months.

 Women has added higher than the physiological requirements VitD.

 Who had taken bisphosphonates or sodium fluoride in the past 1 year.

 Women had been taking Chinese medicines or other unregistered food in past 3 months.

 Women with one of the following medical history or disease: Thrombophlebitis, estrogen-related thrombosis or thromboembolism, Cerebrovascular accident, with known or suspected estrogen-dependent tumor, undiagnosed vaginal bleeding, Cervical Pap smear graded at 3 or more, Serious uterine disorders, Serious breast disorders, Serious gallbladder disease, Severe hypertension and Hypercholesterolemia

 Secondary osteoporosis.

 Participants' lumbar spine anatomy(at least L1

 L4) is not suitable to do dual-energy X-ray absorptiometry measured, such as obvious scoliosis, bone injury and Orthopedic surgery Sequelae.

 Doctor consider inappropriate to participate in because of other diseases.


Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Summary: Nowadays features for the diagnosis of delirium are:~Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;~A change in cognition (such as memory deficit, disorientation, language disturbance) or the development of a perceptual disturbance that is not better accounted for by a pre-existing or evolving dementia;~The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;~There is evidence from the history, physical examination, or laboratory findings that the disorder is caused by the direct physiological consequences of a general medical condition, substance intoxication or substance withdrawal.~Treatment of underlying clinical disease is important to remit the delirium. However, these procedures alone are not enough to remit the delirium early and to prevent sequels. There is a need for a specific and faster strategy to treat the delirium.~The investigators want to test the hypothesis that an Anticholinesterase Inhibitor (donepezil) can reduce the duration of the delirium.
Inclusion criteria: inclusion criteria:

 Over 60 year old

 Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit)

 informed consent (legal representatives)

Exclusion criteria: :

 unable to swallow pills

 previous allergy to donepezil

 Atrioventricular block of 2nd and 3nd degree

['Elderly', 'Delirium of Unknown (Axis III) Etiology', 'Intensive Care (ICU) Myopathy']

Elderly
Delirium of Unknown (Axis III) Etiology
Intensive Care (ICU) Myopathy


Standard Medical Care or Urgent Chest X-ray in Diagnosing Lung Cancer in Smokers With Chest Symptoms Who Are Older Than 60 Years

Summary: RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer treatment. It is not yet known whether standard medical care is more effective than an urgent x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.~PURPOSE: This randomized clinical trial is studying standard medical care to see how well it works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Patients over 60 seeing a participating General Practitioner

 Currently smokes 10 or more pack years, meeting at least one of the following criteria:

 New or altered cough of any duration reported to primary care

 Increased breathlessness or wheezing (with or without purulent sputum)

 Do not qualify for an urgent referral for a chest x-ray under the National Institute for Health and Clinical Excellence (NICE) guidelines (i.e., hemoptysis or unexplained or persistent [lasting > 3 weeks] signs or symptoms), including having any of the following:

 Cough

 Chest/shoulder pain

 Dyspnea

 Weight loss

 Chest signs

 Hoarseness

 Finger clubbing

 Features suggestive of metastasis from a lung cancer (e.g., in the brain, bone, liver, or skin)

 Cervical/supraclavicular lymphadenopathy

 PATIENT CHARACTERISTICS:

 Not specified

 PRIOR CONCURRENT THERAPY:

 No chest x-ray within in past 3 months

 No need for a chest x-ray within the next 3 weeks for reasons other than those listed under Disease Characteristics
Exclusion criteria:

['caregiver-related intervention or procedure', 'questionnaire administration', 'quality-of-life assessment', 'radiography']


Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients

Summary: The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.~In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.
Inclusion criteria: inclusion criteria:

 Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier

 Patient aged 15 or over

 Patient able to understand the nature, purpose and methodology of the study.

 Patient and his legal representative for minors who have given their free and informed consent

 Affiliate or beneficiary of a social security scheme.

Exclusion criteria: :

 Patients on antifungal treatment at the time of sampling

 Pregnant or breastfeeding

 Major protected by law (guardianship, curator or under Backup Justice)

 Inability to understand the nature and goals of the study and / or communication difficulties with the investigator

 Subject attending another search including a period of exclusion still going to run-in

['T specific response for diagnostic of aspergillus bronchitis']

['Cystic Fibrosis Patient', 'Patient Without Treatment Against A.Fumigatus']


Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis

Summary: Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.
Inclusion criteria: inclusion criteria:

 Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9

Exclusion criteria: :

 age > 80

 Recent thrombolytic therapy (with in 4 days)

 Active bleeding or know bleeding diathesis

 Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50

 Thrombocytopenia (PLT cound < 100,000)

 History of any intracranial or intraspinal surgery, trauma or bleed

 Intracranial neoplasms, AVM, or aneurysm

 Recent (< 1 month) GI bleed

 Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy

 Recent (< 7 days) major surgery, trauma, or obstetrical delivery

 Renal insufficiency with eGFR < 45 ml/min

 Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA

 Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP > 90 mm Hg for > 15 min or need for pressor agents to maintain BP > 90.

 Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg.

 Pregnant patients

 known right to left shunt

 Large (>10 mm)intracardiac thrombus

 Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion.

 Life expectancy < 30 days

['submassive PA treatment with Ekosonic endo device']


Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections

Summary: A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subjects with mild renal impairment are not necessary and subjects with more severe degrees of renal failure are excluded.
Inclusion criteria: inclusion criteria:

 Male or female, from 18 to 90 years of age, inclusive

 One of the following diagnoses (in which there is evidence of intraperitoneal infection) including:(a) Cholecystitis (including gangrenous cholecystitis) with rupture, perforation, or progression of the infection beyond the gallbladder wall;(b)Diverticular disease with perforation or abscess; (c) Appendiceal perforation or periappendiceal abscess; (d) Acute gastric or duodenal perforation, only if operated on >24 hours after perforation occurs; (e) Traumatic perforation of the intestine, only if operated on > 12 hours after perforation occurs; (f) Peritonitis due to perforated viscus, postoperative or spread from other focus of infection (but not spontaneous [primary] bacterial peritonitis or peritonitis associated with cirrhosis and chronic ascites).Subjects with inflammatory bowel disease or ischemic bowel disease are eligible provided there is bowel perforation; or (g) Intraabdominal abscess (including liver and spleen).

 Subject requires surgical intervention (e.g. laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug

 If subject is to be enrolled preoperatively, the subject must have radiographic evidence of bowel perforation or intraabdominal abscess

 Subjects who failed prior antibacterial treatment for the current cIAI can be enrolled but must: (a) have a positive culture (from an intraabdominal site) and (b) require surgical intervention. Such subjects can be enrolled before the results of the culture are known; however, if the culture is negative, study drug administration must be discontinued.

 Willing and able to comply with all study procedures and restrictions

 Willing and able to provide written informed consent

Exclusion criteria: :

 Women who are pregnant, nursing, or - if of child bearing potential - not using a medically accepted, effective method of birth control (e.g. condom, oral contraceptive, indwelling intrauterine device, or sexual abstinence)

 Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours; perforation of gastroduodenal ulcer with surgery within 24 hours (these are considered situations of peritoneal soiling before infection has become established); another intraabdominal process in which the primary etiology is not likely to be infectious.

 Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected, necrotizing pancreatitis, or pancreatic abscess

 cIAI managed by staged abdominal repair (STAR), open abdomen technique or any situation where infection source control is not likely to be achieved

 Known prior to randomization to have an IAI or postoperative infection caused by pathogen(s) resistant to meropenem

 Considered unlikely to survive the 4- to 5-week study period

 Any rapidly-progressing disease or immediately life-threatening illness (including acute hepatic failure, respiratory failure and septic shock)

 The need for concomitant systemic antibacterial agents (other than vancomycin or linezolid) in addition to study drug(s)

 Moderate or severe impairment of renal function (estimated CrCl < 50 mL/min), or requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours)

 The presence of hepatic disease defined as: (a) ALT or AST > 4 x ULN; (b)Total bilirubin >2 x ULN, unrelated to cholecystitis (c) Alkaline phosphatase >4 x ULN. Subjects with a value >4 x ULN and <5 x ULN are eligible if this value is historically stable.

 Subjects with acute hepatic failure or acute decompensation of chronic hepatic failure

 Hematocrit < 25% or hemoglobin < 8 gm/dL

 Neutropenia with absolute neutrophil count < 1000/mm3

 Platelet count < 75,000 /mm3. Subjects with a platelet count as low as 50,000 /mm3 are permitted if the reduction is historically stable.

 Immunocompromising illness, including known human immunodeficiency virus (HIV) positivity or AIDS, organ (including bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroid therapy (e.g. >40 mg prednisone or equivalent per day for greater than 2 weeks).

 History of hypersensitivity reactions to cephalosporins, carbapenems, penicillins, ß-lactamase inhibitors, metronidazole, or nitroimidazole derivatives. Subjects with a history of mild skin rash, not documented to be caused by previous ß-lactam use, may be enrolled.

 Any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data

 Clinically significant abnormality in baseline electrocardiogram (ECG)

 Participation in any investigational drug or device study within 30 days prior to study entry

 Use of systemic antibiotic therapy for IAI for 24 or more hours in the 48-hour period prior to the first dose of study drug, unless there is a documented treatment failure with such therapy

 More than one dose of an active non-study antibacterial regimen was given postoperatively. For subjects enrolled preoperatively, no postoperative non-study antibacterial therapy is allowed

 who previously participated in a study with CXA-101

 Subjects who previously received imipenem, meropenem, doripenem or cefepime for the current intraabdominal infection

 Subjects who have received disulfiram in the past 14 days or who are currently receiving probenecid.

['CXA-101/ tazobactam and metronidazole', 'meropenem plus saline placebo']

CXA-101/ tazobactam and metronidazole
meropenem plus saline placebo


Study to Evaluate Safety and Effectiveness of Spinal Sealant

Summary: To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.
Inclusion criteria: inclusion criteria:

 Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation.

 Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria)

 Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds.

Exclusion criteria: :

 Active spinal and/or systemic infection

 Patient requires additional spinal surgery within the study time period

 Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure

 Patient has a pre-existing external lumbar CSF drain or internal CSF shunt

 Patient is participating in a clinical trial of another investigational device or drug

 Patient with creatinine > 2.0 mg/dL

 Patient with total bilirubin > 2.5 mg/dL

 Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation

 Patient has been treated with chronic steroid therapy (>4 weeks) unless discontinued more than 6 weeks prior to surgery

 Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or NSAIDS at the time of surgery

 Patient receiving warfarin or heparin at the time of surgery

 Patient has a diagnosed and documented compromised immune system and/or autoimmune disease

 Patient has has chemotherapy treatment within 6 months prior to, or planned during the study

 Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure

 Patient has known malignancy or other condition with prognosis shorter than 6 months

 Patients with documented history of uncontrolled diabetes

 Patient requires use of synthetic or non-autologous duraplasty material

 Patient has a gap greater than 2mm remaining after primary dural closure

 Patient has undergone laminoplasty decompression

 Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position

 Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level

 The investigator determines that participation in the study may jeopardize the safety or welfare of the patient

 The investigator determines that the patient should not be included in the study for reason(s) not already specified

['Spinal Sealant System', 'Standard of care']

['Spinal Procedure Requiring Dura Incision']


A Study of Risperidone Monotherapy in Bipolar Anxiety

Summary: The specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
Inclusion criteria: inclusion criteria:

 Subjects must be 18 years of age or older.

 Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV criteria.

 Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause does not occur exclusively during a mood disorder of Criterion F for GAD) .

 Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4.

 Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4.

 Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline.

 Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.

 If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, double barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.

Exclusion criteria: :

 Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria.

 Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria.

 Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.

 Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5).

 Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3).

 Subjects with clinically significant suicidal or homicidal ideation.

 Subjects with current psychotic symptoms.

 Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder).

 Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.

 Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests.

 Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone.

 Women who are pregnant or nursing.

 Subjects who have received an experimental drug or used an experimental device within 30 days.

 Subjects who have a history of neuroleptic malignant syndrome.

['Bipolar Disorder', 'Panic Disorder', 'Generalized Anxiety Disorder']

Bipolar Disorder
Panic Disorder
Generalized Anxiety Disorder


Prospective Randomized Comparison of Clinical Results of Hand Assisted Laparoscopic Splenectomies and Open Splenectomies

Summary: ABSTRACT~Background: Although there are some comparative studies between laparoscopy and hand-assisted laparoscopic splenectomy (HALS) in splenomegaly cases, there is no study of the differences between HALS and open splenectomy (OS). Our aim was to compare the HALS and OS techniques in splenomegaly cases.~Methods: This prospective study included 27 patients undergoing splenectomy for splenic disorders at the Department of General Surgery, Istanbul Medical Faculty between February 2007 and October 2007. OS was performed on 14 patients, and HALS was performed in the other 13 patients.~Key words: HALS, open splenectomy, splenomegaly
Inclusion criteria: inclusion criteria:

 Splenomegaly 15 cm or longer spleens

 Patient confirmation to join the study

Exclusion criteria: :

 Normal sized spleens

 Patient denial

:

 Normal sized spleens

 Patient denial


Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Summary: The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.
Inclusion criteria: inclusion criteria:

 Register to the social health insurance

 Referred for a walk test because of claudication

 Maximal walking ditance < 750m

 Older than 18 years old

 Able to understand the protocol of the study

Exclusion criteria: :

 Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months inclusion

 Severe reparatory disease already known

 Parkinson disease, hémiplégia ou paraplégia

 Does not want to participate to the protocol

 Pregnant women

 Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research

 Being in a period of exclusion from another biomedical study


Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

Summary: The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.
Inclusion criteria: inclusion criteria

 Chronic insomnia and taking greater than or equal to 10 mg zolpidem at least 4 times per week.

 Has been prescribed zolpidem for difficulty in initiating sleep.

 Must report chronic use of zolpidem greater than or equal to10 mg therapy for a minimum of 3 months prior to entry into Period 1 of the study.

 Must have taken zolpidem greater than or equal to 10 mg therapy for at least 4 of 7 days each week of the 4 weeks immediately prior to entry into the double blind phase, Period 2.

 Expressed a willingness to discontinue zolpidem therapy.

 Habitual bedtime is between 9:00 PM and 1:00 AM based on sleep history.

 Negative test result for hepatitis B surface antigen and hepatitis C virus antibody.

 Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion criteria:

 Known hypersensitivity to ramelteon, zolpidem, or melatonin.

 Participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of run-in study medication.

 Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of run-in study medication.

 History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.

 History of drug addiction or drug abuse within the past 12 months.

 History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition revised and/or regularly consumes more than 2 alcoholic drinks per day.

 Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of run-in study medication.

 Body mass index of less than 18 or greater than 34 (weight /height2).

 Any clinically important abnormal finding as documented by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.

 Positive hepatitis panel.

 Known history of human immunodeficiency virus.

 Any additional conditions(s) that in the investigator's opinion would affect:

 sleep/wake function

 prohibit the subject from completing the study

 indicate that continuation in the study would not be in the best interests of the subject.

 Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:

 Melatonin

 Anxiolytics

 Antipsychotics

 Over-the-counter and prescription sedatives

 Hypnotics (excluding zolpidem)

 Narcotic analgesics

 Antidepressants

 Beta-blockers (exception is that Atenolol is permissible)

 Anticonvulsants

 St. John's wort

 Sedating H1 antihistamines

 Kava-kava

 Systemic steroids

 Ginkgo-biloba

 Respiratory stimulants

 Over-the-counter and prescription diet aids

 Sedating Decongestants

['Ramelteon and zolpidem', 'Placebo and zolpidem']

Ramelteon and zolpidem
Placebo and zolpidem


ASP (PPI_H2RA) Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA

Summary: Peptic ulcer bleeding associated with ASA or NSAIDs is a major cause of hospitalization in Hong Kong. The investigators previously showed that ASA or NSAIDs accounted for about half of all cases of hospitalizations for peptic ulcer bleeding. Currently, ASA use has contributed to about one-third of the bleeding ulcers admitted to the investigators hospital that serves a local population of 1.5 million.~In patients with acute coronary syndrome or acute ischemic stroke who develop ASA-induced bleeding peptic ulcers, whether ASA should be discontinued before ulcers have healed is a major dilemma. In another double-blind randomized trial, the investigators have shown that discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a significantly increased in mortality within 8 weeks.~In the absence of safer aspirins, co-therapy with a gastroprotective drug remains the dominant preventive strategy. Given the vast number of people taking ASA, however, it is only cost-effective to identify and treat those who are at high risk of ulcer bleeding and who have a strong indication for ASA use. Data from observational studies and randomized trials have consistently shown that PPIs are effective in reducing the risk of ulcer bleeding associated with ASA. Other potential preventive strategies include eradication of H. pylori infection, substitution of ASA for other non-aspirin anti-platelet drugs, and co-therapy with misoprostol or H2RAs.
Inclusion criteria: inclusion criteria:

 A history of documented peptic ulcer bleeding (self-reported history without confirmation by the clinician is not acceptable)

 Negative tests for H. pylori or successful eradication of H. pylori based on urease test or histology

 Expected regular use of ASA for the duration of the trial

 Age ≥ 18

 Written informed consent obtained

Exclusion criteria: :

 A history of gastric or duodenal surgery other than patch repair

 Severe erosive esophagitis (LA grade C or D)

 Gastric outlet obstruction

 Terminal illness

 Active malignancies


Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)

Summary: The goal of the study is to determine the safety and possible effectiveness of various doses of autologous (one's own) stem cells, delivered with a needle into the regions of the leg with poor blood flow in patients with blocked leg arteries that results in claudication (pain when walking). Stem cells are primitive cells produced by the bone marrow that can develop into blood cells or other types of cells. In addition to determining whether this new approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating intermittent claudication - the condition where areas in the leg are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain and cramping upon walking.~This study is a double-blind, randomized study to compare CD34-positive stem cells versus a placebo agent (salt water solution known as normal saline). The patient will have a 3:1 chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or treatment, all patients will undergo all of the pre-treatment phases of this study, which includes the stem cell mobilization and apheresis procedure.
Inclusion criteria: inclusion criteria:

 Males or females equal to or greater than 21 years old

 Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable.

 Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb persisting for at least 6 months (Rutherford Class 3).

 Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months.

Exclusion criteria: :

 Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening.

 Patients with iliac disease amenable to revascularization.

 Patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed.

 Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6.

 Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder.

['Peripheral Artery Disease', 'Severe Intermittent Claudication']

Peripheral Artery Disease
Severe Intermittent Claudication