Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole

Summary: The objectives of the Phase I study are to evaluate the safety and tolerance of increasing single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The description of agent used is single oral dose of an aqueous suspension of oxfendazole, a benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two week safety data for the preceding group have been reviewed. If a clinically significant AE is observed, and if this event is drug-related the safety monitoring committee will be convened to determine whether the study should continue.
Inclusion criteria: inclusion criteria:

 1. Males and females of non-childbearing potential between the ages of 18 and 45 years, inclusive.* *Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who have been postmenopausal for >/=1 year confirmed by LH and FSH levels. 2. In good health, as judged by the investigator and determined by vital signs* Temperature < 38 degrees Celsius, heart rate </=100 bpm and > 50 bpm, systolic blood pressure </= 140 mmHg and > 89 mmHg, diastolic blood pressure </=90 mmHg and >/= 60 mm Hg, medical history and a targeted physical examination. BMI >/=18 and </= 35. Athletically trained subjects with a pulse >/= 45 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator. 3. Acceptable screening laboratories* *Hemoglobin, white blood cell (WBC) count, neutrophil, eosinophil and platelet counts within normal ranges. AST < 44 and ALT < 44 and total bilirubin, creatinine must be equal to or below the upper limit of normal (for eosinophil count, AST, ALT, creatinine, and total bilirubin values below the normal range are acceptable). Random blood glucose must be <140. Urine dipstick testing must be negative for glucose and negative or trace for protein. The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. HIV and hepatitis C viral load PCR testing may be performed for individuals suspected of having indeterminate antibody testing. 4. Male participants must be willing to ensure use of condoms and spermicides for 4 months after study drug administration. 5. Provide written informed consent before initiation of any study procedures. 6. Willing to be available for all study-required procedures, and visits for the duration of the study. 7. Able to provide a home phone number, and the name, address, and/or email of a person willing to assist with making contact during the follow-up phase of the study.

Exclusion criteria: :

 1. History of residing for 6 or more months in regions with endemic cysticercosis as determined by the principal investigator or a designated study physician. 2. Breastfeeding females. 3. Body temperature >/=100.4 degrees Fahrenheit (>/=38.0 degrees Celsius) or acute illness within 3 days before administration of study drug (subject may be rescheduled). 4. Chronic or acute medical disorder* *Disorders of the cardiac, pulmonary, liver, kidney, neurologic, gastrointestinal or other system, such that in the opinion of the investigator participation in the study creates additional risk to the subject, or to the validity of the study. 5. Use of chronic systemic medications* *Intermittent use of over the counter medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for enrollment (please see section 5.6 for instructions on medication use during the study).Topical medications, nasal steroids are permitted throughout the study. Use of the prescription medications used less than once per week on average are permitted for enrollment (see section 5.6 for instructions on medication use during the study). If the subject has taken a short term prescription medication within the past 30 days (e.g. an antibiotic), they should be postponed from enrollment until 30 days have elapsed since the last dose 6. Has history of sensitivity to related benzimidazole compounds (e.g., albendazole, mebendazole). 7. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt. 8. A history of treatment for any other psychiatric disorder in the past 3 years.* *Past treatment for ADHD does not exclude participants from enrollment as long as the medications have been discontinued for a minimum of 3 months and symptoms are well controlled. 9. Received an experimental agent* within 1 month before administration of study drug or expect to receive an experimental agent during the 15-day study period. *Vaccine, drug, biologic, device, blood product, or medication. 10. Any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury, render them unable to meet the requirements of the protocol, or that may interfere with successful completion of the study. 11. A history of alcohol consumption* or any illicit drug use†, or history of substance abuse#. Individuals must agree to abstain from drug or alcohol use for 48 hours prior to enrollment through day 15. *Greater than 7 alcoholic drinks per week. †Other than occasional marijuana use (less than once per week for the past 60 days is acceptable). #Alcohol or illicit drugs within the past 3 years. 12. History of chronic tobacco use in the past 60 days.* *A history of occasional tobacco use (less than 1 pack per week on average) is acceptable. Individuals will be counseled to abstain from use of tobacco and marijuana from screening through day 15.


Pilot Study of Infrared Imaging of Cutaneous Melanoma

Summary: Design: this is a pilot study of infrared imaging of cutaneous lesions in patients and volunteers with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions eligible for this imaging study. Participants will be evaluated with infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma deposits that are to be biopsied, or at cutaneous sites with other lesions, including other skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal cysts, dermatofibromas, scar, healing wound, etc.).
Inclusion criteria: inclusion criteria:

 Patients or volunteers with or without a history of melanoma.

 One or more palpable skin or subcutaneous lesions for which at least one of the following is true:

 A tissue diagnosis has been made for the lesion(s) in question, by prior cytologic or histologic evaluation (Category A1).

 A tissue diagnosis will be obtained for the lesion(s) in question by cytologic or histologic evaluation (Category A2).

 A tissue diagnosis is not available, but a clinical diagnosis of melanoma or benign lesion is available with a high degree of confidence. Examples are hemangiomas, skin tags, seborrheic keratoses, dermatofibromas, lipomas, or growing pigmented skin lesions that are comparable to other cutaneous metastases of melanoma in the same patient (Category B).

 All patients must have the ability and willingness to give informed consent and must be age 18 years or older at the time of study entry.

Exclusion criteria: :

 Known or suspected allergy to the adhesive skin markers or water-soluble ink used for the labeling of lesions.

 Very fragile skin that may be susceptible to injury from adhesive markers.

 Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.


HAL-RAR Versus Hemorrhoidectomy in the Treatment of Grade III-IV Hemorrhoids. Prospective, Randomized Trial

Summary: HYPOTHESIS~HAL- RAR causes a lower immediate postoperative pain compared with excision hemorrhoidectomy.~HAL - RAR achieves similar immediate and long term results compared to the excision hemorrhoidectomy in the control of hemorrhoidal symptoms.~The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.~OBJECTIVES~Compare postoperative pain of both techniques.~Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique, and compare the results with those of the excision hemorrhoidectomy.~Evaluate and compare the rate of complications of both techniques.~Assess the quality of life of patients before and after treatment.
Inclusion criteria: inclusion criteria:

 Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or prolapse) that are eligible for surgical treatment with both methods.

Exclusion criteria: :

 Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure, perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal stenosis.

 Prior anorectal surgery .

 Systemic pathology that could alter the outcome of the surgery as coagulopathies, chronic pain with continued consumption of analgesics.

 Age younger than 18 or older than 80 years, socio-pathology or inability to understand the study objectives


Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

Summary: Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.
Inclusion criteria: inclusion criteria:

 14 to 30 years of age

 Willing to participate in follow-up for at least two years

 Acute, first-time, traumatic, isolated anterior dislocation of the shoulder

Exclusion criteria: :

 Previous instability of the affected shoulder

 A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder

 Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments

 Incompetent or unwilling to consent

 A medical condition making the patient unable to wear a sling

 Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%)

 Neurovascular compromise of the affected limb

 Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.

['External rotation shoulder sling', 'Internal rotation shoulder sling']

External rotation shoulder sling
Internal rotation shoulder sling


Italian Pulmonary Embolism Registry - IPER

Summary: RAZIONALE~Pulmonary embolism is a complex disease, with a highly variable clincal presentation. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Pulmonary embolism can be managed by emergency department, cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical management can varies based on the attitude of the attending physician.~Diagnosis is a crucial point as it can influence short term mortality.~OBJECTIVE~The registry has 3 main objectives:~educational objective,~improvement in the knowledge of epidemiology, management and outcome of acute pulmonary embolism in Italy~scientific objective
Inclusion criteria: inclusion criteria:

 consecutive patients with acute pulmonary embolism

Exclusion criteria: :

 age <18 years


Evaluation of the LMWH Thromboprophylaxis in Pregnancy

Summary: The project aims to clarify the effect of the thromboprophylactic LMWH dose on coagulation in pregnant women just before birth, at the period of maximal physiological hypercoagulable state and with high risk of thromboembolism, the most common cause of maternal mortality in developed countries. Although LMWH are now routinely administered as prevention of thromboembolism, their effect on coagulation in pregnant women was not yet studied. The doses of LMWH in pregnancy are only derived in terms of coagulation from totally different groups of patients (surgical, orthopedic). We therefore will map the effect of thromboprophylactic LMWH dose on coagulation in pregnant women using recently available methods, especially a complex examination of coagulation within 24 h after LMWH application using thrombelastography, including examination with heparinase, and monitoring the effect of LMWH by measuring antiXa and TGT (thrombin generation time) activity. Based on these results we will also evaluate the possible influence of LMWH prophylaxis on the risk of spinal haematoma during neuraxial analgesia/anesthesia for delivery/Caesarean section. On the basis of our pilot results we can presume the current dosage of LMWH in pregnant women is inadequate and that it would be appropriate to adjust presently used dosage. At the same time we want to prove that the standard LMWH thromboprophylaxis in pregnant women does not increase the risk of spinal haematoma during neuraxial blockade. In both situations the targeted outcome is to increase the safety of pregnant women.
Inclusion criteria: inclusion criteria:

 pregnant women undergoing planned caesarean section

 39th-40th week of pregnancy

 age 18-40 years

Exclusion criteria: :

 disapproval or non-cooperation of the mother

 allergy to LMWH

 coagulation disorders or the risk of

 anticoagulant therapy in the last 3 months

 signs of infection

 history of cancer

 signs of thrombosis or a history of thrombosis

 the ongoing non-physiological pregnancy

 significant obesity, or other severe comorbidity


Thermoregulation in the Preterm Infant

Summary: The purpose of this study is to compare the response of temperature adaptation in preterm infant using the polyethylene wrap with and without previous drying.
Inclusion criteria: inclusion criteria:

 Preterm Infant were included according with the Official Mexican Norm -007-SSA2-1993 (1995)

Exclusion criteria: :

 Preterm Infant were not included in case of malformations that involved lost of the cutaneous integrity or in case of severe cardiac congenital disease.

['Polyethylene for thermoregulation in the preterm infant']


Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy

Summary: The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Inclusion criteria: inclusion criteria:

 Postmenopausal women or men > 60 years

 DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy

 Pretreatment with bisphosphonates for at least four years

 Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009

 Signed informed consent

Exclusion criteria: :

 Other pharmacological treatment of osteoporosis during the last 48 months

 Other bone diseases

 Malabsorption syndromes

 Renal insufficiency with a calculated creatinine clearance < 35 ml/min

 Diseases of the esophagus, delayed esophageal clearance

 UUnability to realise the intake instructions

 Hypocalcemia


Assessment of Cough and Wheeze With Breath Sound Documenting Device

Summary: The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.
Inclusion criteria: inclusion criteria:

 Patient and/or parents/guardian signed informed consent

 Patients with cough or shortness of breath

Exclusion criteria: :

 Chest tubes

 Skin lesions precluding attachment of sensors

 Respiratory distress

 Pregnant women

['PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies']


Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study

Summary: The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.
Inclusion criteria: inclusion criteria:

 Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.

Exclusion criteria: :

 Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.

['Primary Hypertension', 'Hypertension, Resistant to Conventional Therapy']

Primary Hypertension
Hypertension
Resistant to Conventional Therapy


Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation

Summary: The purpose of this study is to establish a genebank repository of blood samples and data to generate information about the hereditary (genetic) basis of atrial fibrillation.
Inclusion criteria: inclusion criteria for Atrial Fibrillation group:

 Male or female at least 18 years old

 Subjects with a history of or current Atrial Fibrillation

 Subjects able to give informed consent
Exclusion criteria:  for Atrial Fibrillation group: no history of atrial fibrillation

 inclusion criteria for Controls:

 Male or female at least 18 years old

 Subjects with no history of Atrial Fibrillation

 Subjects able to give informed consent


Home Monitoring in the Management of Hypertension and Diabetes Mellitus

Summary: The home monitoring of automated measuring devices may improve the management of the chronic diseases, and may decrease the incidence of fatal disease. The investigators conducted a small sample and short observation time research to explore the feasibility to carry out later large-scale research.
Inclusion criteria: inclusion criteria:

 Regardless of whether they are currently receiving antihypertensive therapy, systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg.

 Whether or not use oral hypoglycemic agents or insulin injections, the fasting plasma is higher than 7.0 mmol/L, or postprandial blood glucose higher than 11.1 mmol/L.

Exclusion criteria: :

 With life-threatening disease.

 With the various effects of metabolic diseases such as hyperthyroidism, hypothyroidism, etc.

 Stroke, myocardial infarction and other serious cardiovascular and cerebrovascular diseases occurred within 3 months.

 Serum creatinine level higher than 176.8 mmol/L

 Dementia or severe cognitive decline

 Unable to do a long-term follow-up or do not agree to participate in this trial.

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


Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer

Summary: RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future.~PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.
Inclusion criteria: inclusion criteria:

 Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:

 Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following criteria:

 CIN grade 2-3 or higher

 Repeated CIN1 (times 6)

 Abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS] or worse)

 HIV seropositive

 Negative cytology but positive for high-risk human papillomavirus (HPV)

 Negative cytology and negative HPV

 HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)

 >= 18 years of age

 Intact cervix

 Not pregnant

 Able to provide informed consent

Exclusion criteria: :

 < 18 years of age

 Pregnant at screening

 Cervix not intact

 not able to provide informed consent

['Cervical Cancer', 'Precancerous Condition']


Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume

Summary: This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20 mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice spiral CT. Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also evaluated.
Inclusion criteria: inclusion criteria:

 Written informed consent

 Men or women, aged 18 -75

 Diagnosed with coronary heart disease (CHD) stable angina for more than 1 month and meet the following any one:

 History of myocardial infarction.

 CHD confirmed by coronary angiography.

 Excercise ECG positive for CHD or perfusion defect

 One or more main branch of coronary artery stenosis ≥ 50% confirmed by CT scanning.

 Hyperlipidemia (lipid-lowering treatment naïve: LDL-C ≥130mg/dl, or having received lipid-lowering treatment: LDL-C ≥100mg/dl)

 The 64 slice CT shows at least one significant coronary artery stenosis ≥20% with the narrowest ≤60% and meeting the following criteria:

 Diameter of coronary artery lesion ≥2mm, length ≥5mm; distance between multiple lesions >1cm

 Plaque density <100HU, no calcification

 Vascular stenosis (20～60%) caused by plaques

 Plaque thickness >1mm

 Plaque not in the coronary artery with previous PCI treatment.

Exclusion criteria: :

 Acute myocardial infarction within 6 months

 PCI or CABG therapy within 6 months

 Anticipated PCI or CABG therapy in the following 3 months.

 Tropnin I/Tropnin T higher than ULN

 Cardiac failure NYHA III or above

 Coronary artery left main stenosis >50%

 Emergency coronary angiography(CAG) is needed

 Serious arrhythmia or tachycardia

 Secondary hyperlipidemia

 Familial hypercholestrolemia

 Uncontrolled severe hypertension (≥200/110 mmHg)

 Uncontrolled diabetes (HbA1c ≥9.5%)

 Triglyceride ≥500 mg/dL (5.65 mmol/L)

 Active hepatic disease or hepatic function impairment, ALT≥3ULN

 Serum creatinine >177 µmol/L (2.0 mg/dL)

 Myalgia or blood CK ≥5ULN

 WBC < 4×10e9/L，or PLT < 100*10e9/L。

 Participation in the the course of plan and/or procedure of this study

 Previous participation in the study treatment

 Participation in other clinical studies in the past 3 months

 Pregnant or breast-feeding women, women with child-bearing potential who did not use drugs or devices for contraception, or women with positive urine pregnancy test (human chorionic gonadotropin [HCG])

 History of malignant tumors (exception: recovered more than 10 years or only basal cell carcinoma or squamous cell carcinoma); females with a history of cervical atypical hyperplasia (exception: 3 consecutive cervical smear tests normal prior to enrolment)

 History of alcohol and/or drug abuse in recent 5 years

 Any serious or unstable physical or psychological conditions, in the opinion of the investigator, would compromise the safety of the patient or the participation in this study

 Use of concomitant medications prohibited in this study ( Erythromycin, clarithromycin, erythromycin ethylsuccinate, sulfaphenazole; Fluconazole, ketoconazole, itraconazole; Niacin / nicotinic acid(including vitamins/food additives containing niacin / nicotinic acid >50mg), probucol, clofibrate, cholestyramine, colestipol hydrochloride, ezetimibe, fenofibrate, gemfibrozil, atorvastatin(exception: study medication)，lovastatin, pravastatin, rosuvastatin (exception: study medication) , Simvastatin, fluvastatin, fish oil (any dose), lipid-lowering supplements and food additives; Cyclosporine; Protease inhibitors)

 Use of periodic hormone replacement treatment(HRT), oral contraceptives(OCTs), long-acting progesterone, or in recent 3 months non-periodic HRT or OCTs

 Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding

['Hyperlipidemia', 'Coronary Artery Disease']


TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia

Summary: Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.~This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.
Inclusion criteria: inclusion criteria

 The infant will be assessed sequentially by criteria A, B and C listed below:

 A. Infants =>36 completed weeks gestation admitted to the Neonatal Intensive Care Unit (NICU) with at least one of the following:

 Apgar score of =<5 at 10 minutes after birth

 Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth

 Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord, arterial or capillary pH <7.00)

 Base Deficit =>16 mmol/L in umbilical cord or any blood sample (arterial, venous or capillary) within 60 minutes of birth

 Infants that meet criteria A will be assessed for whether they meet the neurological abnormality entry criteria (B) by trained personnel:

 B. Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following:

 hypotonia

 abnormal reflexes including oculomotor or pupillary abnormalities

 absent or weak suck

 clinical seizures

 Infants that meet criteria A & B will be assessed by amplitude-integrated electroencephalogram (aEEG) (read by trained personnel):

 C. At least 30 minutes duration of amplitude integrated EEG recording that shows abnormal background aEEG activity or seizures. There must be one of the following:

 normal background with some seizure activity

 moderately abnormal activity

 suppressed activity

 continuous seizure activity

Exclusion criteria:

 Infants expected to be > 6 hours of age at the time of randomisation

 Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis

['Asphyxia Neonatorum', 'Hypoxia', 'Encephalopathy', 'Seizures']

Asphyxia Neonatorum
Hypoxia
Encephalopathy
Seizures


CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function

Summary: The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the incidence of symptomatic hypotension being one of the key safety variables.
Inclusion criteria: inclusion criteria:

 Significant chest discomfort and /or shortness of breath

 ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads

 Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or any mechanical forms of revascularization, including stent, PTCA, thrombectomy, etc. within 24 hours of onset of symptoms as documented by coronary angiography

 No previously known history of AMI (prior to current cardiac event) or no previous ECG (prior to current cardiac event) suggesting an old AMI (Q wave on presenting ECG is not an exclusion)..

Exclusion criteria: :(Assessed at the time of enrollment unless otherwise stated)

 Cardiogenic shock, acute heart failure or hypotension (Systolic BP < 90 mmHg)

 Previous known decreased EF < 40%

 Atrial Fibrillation

 Persistent signs and symptoms of Post MI ischemia

 Requirement of pressors for maintenance of blood pressure.

 Intra-aortic blood pump use

 Significant (moderate-severe) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension.

 Severe congenital heart diseases

 Sustained ventricular tachycardia or ventricular fibrillation

 Second or third degree heart block without a permanent cardiac pacemaker

 Stroke within 3 months or other evidence of significantly compromised CNS perfusion

 Total bilirubin of > 2.5 mg/dL or other liver enzymes >2.5 times the upper limit of normal if available clinically and measured within the last 7 days

 Patients with calculated GFR <30 ml by MDRD equation or those with acute kidney injury as defined by an increase of plasma creatinine of 0.5 mg/dL from a plasma creatinine measured within the last 7 days

 Serum sodium of < 125 mEq/dL or > 160 mEq/dL if available clinically and measured within the last 7 days

 Serum potassium of < 3.0 mEq/dL or > 5.8 mEq/dL if available clinically and measured within the last 7 days

 Hemoglobin < 8.5 gm/dl if available clinically and measured within the last 7 days

 Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data

 Received an investigational drug within 1 month prior to dosing

 Female subject who is pregnant or breastfeeding

 In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons

['ST Elevation (STEMI) Myocardial Infarction of Anterior Wall']


Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy

Summary: Confinement to bed, which occurs in many pathological situations, induces a muscle atrophy and a loss of muscle strength. Muscle atrophy is associated to impaired performance in motor tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy. It requires a stay in follow-up and rehabilitation service, and thus lengthens the duration of hospitalisation.~Data underline the importance of afferent input integrity in the maintenance of muscle characteristics and postural control, and suggest that countermeasure programs based on the stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls. In particular, fundamental studies performed in rodents by the investigators laboratory have demonstrated that the adverse structural and functional adaptations which occur during muscle deconditioning can be counteracted through adequate physiological stimuli such as activation of proprioceptors. Based on this scientific expertise, the investigators aim is thus to prevent muscle atrophy and its functional consequences on posture and locomotion, following a surgical intervention in humans .~The investigators will develop a device allowing stimulation of foot and ankle proprioceptors. In order to facilitate the evaluation of its efficiency, the device will be tested on a selected population confined to bed during a post-operative period (knee replacement). It efficiency will be evaluated by means of three parameters: muscle force of ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and balance analysis).~The technique developed in the present project could bring benefits to patients confined to bed, or in elderly. Preventing or retarding development of muscle atrophy will beneficiate to health and quality of life of these patients. In addition, this device might allow to consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.
Inclusion criteria: inclusion criteria:

 patients waiting for knee replacement

Exclusion criteria: :

 neurologic disease


The Effects of Cold Liquids on the Swallowing Mechanism in Preterm Infants

Summary: The purpose of this study is to see if cold liquids improve the swallowing mechanisms in premature infants with swallowing difficulties (dysphagia). The only way to objectively diagnose dysphagia is by having that infant undergo a Video Fluoroscopic Swallow Study (VFSS), which allows direct visualization of the liquid bolus (barium) in real time. Infants suspected of having dysphagia and who are referred for a VFSS will be recruited for this study. Once consented, the infant will undergo a standard VFSS. If that infant is diagnosed with dysphagia, the study protocol will begin by keeping the infant the same position and feeding them cold liquid barium from an identical bottle. A total of 5 swallows will be visualized, which adds approximately 5-10 seconds to the study. Both the standard swallows and the study swallows will be recorded for analysis and comparison. It is hypothesized that the study swallows will have less deficits than the standard swallows. If an infant's standard VFSS does not indicate dysphagia, that infant will no longer be eligible for this study.
Inclusion criteria: inclusion criteria:

 Infants born prematurely, as defined by birth at less than 37 weeks gestational age, referred for a videofluoroscopic swallow study (VFSS) due to suspected pharyngeal phase dysphagia.

Exclusion criteria: :

 Infants born prematurely with a corrected gestational age of 43 weeks or greater.


Collection of Lung Fluid and Tissue Samples for Research

Summary: This study will collect fluid and tissue specimens from the lungs and nose of healthy people and people with a history of lung infections. The specimens will be examined for differences between the two groups that may be associated with susceptibility to certain infections.~Healthy normal volunteers and people with a history of lung infections between 18 and 75 years of age who are followed at NIH may be eligible for this study.~Participants undergo the following procedures:~Medical history and physical examination.~Blood and urine tests.~Electrocardiogram (ECG) and chest x-ray.~Treadmill exercise stress test (for people over 45 years old with a history of chest pain or ECG abnormalities).~Bronchoscopy: The subject s nose and throat are numbed with lidocaine and a sedative is given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully.~Fluid collection during the bronchoscopy using one of the following methods:~Bronchoalveolar lavage: Salt water is injected through the bronchoscope into the lung and immediately suctioned out, washing off cells lining the airways.~Bronchial brushings: A brush-tipped wire enclosed in a sheath is passed through the bronchoscope and a small area of the airway tissue is gently brushed. The brush is withdrawn with some tissue adhering to it.~Endobronchial biopsies: Small pinchers on a wire are passed through the bronchoscope and about 1 to 2 millimeters of tissue is removed.~Nasal scrape: A small device is used to scrape along the inside of the nose to collect some cells.
Inclusion criteria: HEALTHY VOLUNTEER inclusion criteria FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES:

 18 to 75 years of age

 Enrolled without regard to gender, race, or ethnicity

 NIH employees or non-employees eligible

 Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process

 Able and willing to complete the informed consent process

 Able and willing to arrange to have another person drive them home after the procedure

 Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure

 Willing to donate blood and respiratory tract samples for storage to be used for future research

 In good general health without clinically significant medical history

 Physical examination without clinically significant findings

 Screening laboratory tests without clinically significant abnormalities:

 Complete blood count with differential

 Serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes and function tests, electrolytes

 HIV test and hepatitis serologies (HBsAg; HCV) if status is unknown

 Prothrombin time, partial thromboplastin time

 Urinalysis

 Female subjects must have negative urine pregnancy test within 1 week of participation and continue birth control practices prior to participation

 Chest radiograph (CXR) (if the subject has not had a CXR or computerized tomography [CT] scan of the chest within the prior7 days)

 Pulse oximetry

 Electrocardiogram (ECG)

 Treadmill exercise stress test (as indicated for history of angina or abnormalities on ECG)

 HEALTHY VOLUNTEER
Exclusion criteria:  FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES:

 Less than 18 or greater than 75 years old

 A smoking history of 10 pack-years or more, a current smoker, or tobacco free for less than a year.

 Positive HIV status. Subjects must have a negative FDA-approved HIV blood test. [Note: Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study]

 Acute or chronic hepatitis based on viral hepatitis serologies

 Pregnancy or breastfeeding

 Any active medical problems especially bleeding disorders, significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws, use of anticoagulants, or pulmonary disorders including asthma

 History of allergic reaction to lidocaine, sedative medications like Valium Trademark or Versed Trademark, or narcotic medications like morphine or fentanyl

 Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics is not excluded).

 Use of platelet inhibitors including aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days of procedure

 Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent

 PATIENT inclusion criteria FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES

 18 to 75 years of age inclusive

 Known or suspected respiratory infections or infection susceptibility

 Enrolled without regard to gender, race, or ethnicity

 Must be enrolled in a concurrent NIH protocol and under the care of a primary physician outside of the NIH

 Able and willing to complete informed consent process

 Able and willing to arrange to have another person drive them home after the procedure

 Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure

 Willing to donate blood and respiratory tract samples for storage to be used for future research

 PATIENT

['Leukocyte Disorders', 'Respiratory Tract Diseases', 'Bronchoscopy']

Leukocyte Disorders
Respiratory Tract Diseases
Bronchoscopy


Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

Summary: The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness.~The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.
Inclusion criteria: inclusion criteria:

 Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:

 Congestive heart failure (New York Heart Association [NYHA] class III/IV);

 Acute respiratory failure (not requiring mechanical ventilation);

 Acute infection (without septic shock)*;

 Acute rheumatic disorder*;

 Acute episode of inflammatory bowel disease*.

 Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:

 Age ≥ 75 years;

 Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months);

 Previous VTE;

 Obesity;

 Oral hormone therapy (antiandrogen or estrogen);

 Chronic heart failure;

 Chronic respiratory failure.

Exclusion criteria: :

 Previous surgery with general anesthesia within 30 days before inclusion in the study;

 Patient requiring a curative anticoagulant or thrombolytic treatment;

 Patient at risk of bleeding;

 Stroke;

 Known hypersensitivity to heparin or enoxaparin sodium;

 End stage renal disease or patient on dialysis.

 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

['Semuloparin sodium', 'Enoxaparin sodium']


iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma

Summary: The purpose of this study is to find the largest safe dose of GD2-T cells (also called iC9-GD2-CAR-VZV-CTLs) in combination with a varicella zoster vaccine and lymohodepleting chemotherapy. Additionally, we will learn what the side effects of this treatment are and to see whether this therapy might help patients with advanced osteosarcoma and neuroblastoma. Because there is no standard treatment for recurrent/refractory osteosarcoma and neuroblastoma at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells.~The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.~Investigators have found from previous research that a new gene can be put into T cells that will make them recognize cancer cells and kill them. Investigators now want to see if a new gene can be put in these cells that will let the T cells recognize and kill sarcoma and neuroblastoma cells. The new gene is called a chimeric antigen receptor (CAR) and consists of an antibody called 14g2a that recognizes GD2, a protein that is found on sarcoma and neuroblastoma cells (GD2-CAR). In addition, it contains parts of the CD28 and OX40 genes which can stimulate T cells to make them live longer.~Investigators have found that CAR-T cells can kill some of the tumor, but they don't last very long in the body and so the tumor eventually comes back. T cells that recognize the virus that causes chicken pox, varicella zoster virus (VZV), remain in the bloodstream for many years especially if they are stimulated or boosted by the VZV vaccine. Investigators will therefore insert the GD2-CAR gene into T cells that recognize VZV. These cells are called iC9-GD2-CAR-VZV-specific T cells but are referred to as GD2-T cells for simplicity.
Inclusion criteria: inclusion criteria:

 Procurement:

 Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment.

 Either previously infected with varicella zoster virus(VZV; chicken pox) or previously vaccinated with VZV vaccine

 Karnofsky/Lansky score of greater than or equal to 50

 Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

 Treatment:

 Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment.

 Recovered from the acute toxic effects of all prior chemotherapy

 Karnofsky/Lansky score of greater than or equal to 50

 Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, Serum creatinine less than or equal to 2x upper limit of normal, Hgb greater than or equal to 7.0 g/dl, ANC>500/uL, platelets > 50,000/uL

 Pulse oximetry of greater than or equal to 90% on room air

 Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. Male partner should use a condom.

 Available autologous transduced cytotoxic T lymphocytes with greater than or equal to 20% expression of GD2 CAR and killing of GD2-positive targets greater than or equal to 20% in cytotoxicity assay

 Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

Exclusion criteria: :

 Procurement:

 • Known primary immune deficiency or HIV positivity

 Treatment:

 Severe intercurrent infection

 Known primary immune deficiency or HIV positivity

 Pregnant or lactating

 History of hypersensitivity reactions to murine protein-containing products

 Known allergy to VZV vaccine

['GD2 T cells', 'VZV vaccine', 'Fludarabine', 'Cyclophosphamide']

GD2 T cells
VZV vaccine
Fludarabine
Cyclophosphamide


Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study

Summary: The aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.
Inclusion criteria: inclusion criteria:

 Symptom of low back pain during last 4 weeks

 Low back pain history for more than 3 months

Exclusion criteria: :

 Have lower limbs radiating pain beyond knee joints

 Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases

 Spinal surgical history

 Severe heart, lung, liver, kidney disease or high blood pressure

 With cardiac pacemaker

 Coagulopathy or thrombosis

 Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months

 Mental illnesses or none cooperation

 Pregnancy

['Radial Extracorporeal Shock Wave Therapy 2000 impulses', 'Radial Extracorporeal Shock Wave Therapy 4000 impulses']


Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel

Summary: The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS).~The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients.
Inclusion criteria: inclusion criteria:

 Person is over the age of 20 but not older than age 45.

 Person is willing to participate as evidenced by signing the written informed consent form.

 Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity)

 Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may include one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity.

 At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency

 At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities

 At least one of the PMS symptoms interfere with relationships with others:

 i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow.

 ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days.

 iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms.

 iv. Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle.

 v. Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms.

 vi. Reliable non hormonal contraception.

Exclusion criteria: :

 Pregnant or lactating woman

 Oral contraceptives during last three months, including hormonal IUD (trade name mirena).

 Serious health problems.

 Unexplained menstrual disorders.

 Treated by hormones (estrogen and progesterone).

 For healthy: Irregular or abnormal test results.


Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age

Summary: Two-arm cluster randomized controlled trial located in Hala district, Pakistan to determine the impact of using Lady Health Workers (LHW) of National Program for Family Planning and Primary Health Care to diagnose and manage severe pneumonia with oral amoxicillin on treatment failure rates at day 6 among 2-59 month old children. LHWs in the control arm receive a refresher in standard pneumonia case management. LHWs in the intervention arm receive standard training that is enhanced to include training in the recognition of severe pneumonia and its home management with oral amoxicillin. Clusters are by Union Council (UC), administrator units consisting of 7 to 25 LHWs; each UC is randomized to either enhanced pneumonia case management with oral amoxicillin therapy (intervention) for severe pneumonia or standard case management and referral to the nearest health facility for treatment (control). Process indicators reflecting the LHW's ability to assess, classify and treat pneumonia in the intervention group and cost-effectiveness data is also being collected.~Primary Hypothesis:~Enhanced pneumonia case management and oral amoxicillin therapy for severe pneumonia delivered by LHWs in the community will result in a reduction in treatment failure among children 2 - 59 months of age with severe pneumonia who are treated by the LHW compared with those referred for care by the LHW.~Secondary Hypotheses:~The proportion of treatment failure, [persistence of lower chest indrawing (LCI) or need for second line treatment between day 3 and day 14], will be less in the intervention arm compared with the control arm.~LHWs can adequately assess, classify, and treat severe pneumonia in 2 - 59 month old children, and adequately recognize and refer children who present with danger signs during initial antimicrobial therapy.
Inclusion criteria: inclusion criteria:

 Age between 2 to 59 months who present to LHWs with severe pneumonia.

 Informed consent given by a legal guardian.

Exclusion criteria: :

 Very severe disease.

 Persistent vomiting.

 Parental or caretaker refusal to participate in the study.

 Children currently being treated for non-severe pneumonia who advance to severe pneumonia.

 Suspected or known kerosene oil ingestion.

 Prior enrollment in the study within 2 weeks of last follow up

 Children with severe malnutrition . Children with severe diarrhea with signs of dehydration

['Amoxicillin', 'Referral to Health facility']


Longitudinal Pattern of Streptococcus Pneumoniae Nasopharyngeal Carriage and Antimicrobial Susceptibility in Healthy Children Aged Less Then 5 Years, in the Area of Milan and Surroundings, Lombardy, Italy.

Summary: The objective of this active surveillance study is to make available crucial data about epidemiology, serotype distribution, and longitudinal pattern of antibiotic susceptibility of nasopharyngeal strains of Streptococcus pneumoniae carried in the population of healthy children aged less than years and living in the area of Milan and surroundings, Lombardy, Italy.~To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy;~To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years~Secondary objectives:~To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;~To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;~• To evaluate the possible impact of vaccination policy in the referenced population.
Inclusion criteria: inclusion criteria:

 To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy;

 To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than5 years

Exclusion criteria: :

 To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;

 To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;

 To evaluate the possible impact of vaccination policy in the referenced population..

['Streptococcus Pneumoniae Nasopharyngeal Carriage']


Protein Supplementation and Weight Loss

Summary: This randomized control trial of diet with protein supplementation is being conducted to test the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss and improvement in cardio-metabolic profile.
Inclusion criteria: inclusion criteria:

 Subjects aged between 21 -65 years

 Subjects with BMI > 23 Kg/m2

Exclusion criteria: :

 inclusion criteria:

 Subjects aged between 21 -65 years

 Subjects with BMI > 23 Kg/m2


Study of Evaluation Indexes for Antibody Production in Sera After Immunization

Summary: The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.
Inclusion criteria: inclusion criteria:

 elderly subjects over the age 65 years who had not received pneumococcal vaccination

 adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)

 children subjects over the age of 2 years with no previous history of pneumococcal vaccination

Exclusion criteria: :

 immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine


Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment

Summary: Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment
Inclusion criteria: inclusion criteria:

 patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention

 patients with mild or moderate renal impairment

 age >= 18 years at enrollment

Exclusion criteria: :

 - severe renal impairment (Creatinine Clearance < 30 ml/min)


Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery

Summary: We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of the attachment of white blood cells to the endothelium. Our study population was neonates and infants undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of congenital heart defects.
Inclusion criteria: inclusion criteria:1) scheduled cardiac surgery with hypothermic CPB to repair either D-transposition of the great arteries (D-TGA) with intact ventricular septum (IVS) or ventricular septal defect (VSD), VSD with or without aortic arch obstruction (AAO), tetralogy of Fallot (TOF) with or without pulmonary atresia (PA), truncus arteriosus, total anomalous pulmonary venous return (TAPVR), or double outlet right ventricle (DORV), or to palliate hypoplastic left heart syndrome (HLHS) or other forms of single ventricle (SV) with AAO using the stage I (Norwood) operation, 2) age 1-45 days at surgery, 3) birth weight > 2.3 kg, and 4) a cranial ultrasound < 1 week prior to enrollment showing at most grade II hemorrhage in high risk patients -

Exclusion criteria: :


QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

Summary: QT dispersion can be a useful, simple noninvasive method for the early detection of cardiac involvement in SLE patients with active disease. The investigators therefore recommend cardiovascular evaluation for every SLE patient with an SLEDAI higher than 10.
Inclusion criteria: inclusion criteria:

 no administration of drugs that would potentially influence QT duration except hydroxychloroquine

 no history of ischemic heart disease, congestive heart failure, atrial fibrillation, bundle branch block or abnormal serum electrolytes

 normal resting ECG and a good-quality ECG recording to measure the QT interval.

Exclusion criteria: :

 moderate or severe valve disease

 atrial fibrillation and other ECG abnormalities

 systolic left ventricular dysfunction (ejection fraction <50% or left ventricular end diastolic dimension >5.5 mm

 unreliable identification of the end of the T wave in the ECG and

 known presence of cardiac disease including hypertension, diabetes or coronary artery disease.


Central Hypothyroidism and Cardiovascular Risk

Summary: Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk factors. The hypothesis is that subtle central hypothyroidism is associated with adverse cardiac risk factors, such as body composition and serum lipids, and that improved T4 replacement will eliminate this increased risk, independently of other pituitary hormone replacements.
Inclusion criteria: inclusion criteria:

 All patients with pituitary hypopituitarism

Exclusion criteria: :

 Unavailability of data


Acromegaly & Sleep Apnoea

Summary: Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. To have a greater effect on long-term outcomes this disease needs to be detected early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be able to detect these patients earlier and prevent late complications of the disease. At LTHT the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to warrant referral to the treatment group for continuous positive airway pressure (CPAP), weight management, and occasionally mandibular adjustment.~Patients attending the sleep apnoea clinic either as new referral or for review will be asked to participate in the proposed study. The study is cross-sectional in design incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under follow-up known to have sleep apnoea, and the second cohort those patients prospectively attending the sleep apnoea clinic for assessment. If after an explanation of the study they agree to participate blood will be taken for assessment of IGF-I and they will be asked to complete a simple questionnaire.~The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are elevated patients will be investigated further for the possibility of acromegaly. The presence of biochemically proven acromegaly will be used to determine if the simple question has sufficient sensitivity to use as a screening tool.
Inclusion criteria: inclusion criteria:

 Adults aged 16 and above.

 Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea

 Have capacity to given informed consent.

Exclusion criteria: :

 Patients under 16 years of age

 Not referred to the Sleep Apnoea Clinic

 Unable to give informed consent


Effect of a Tracking Program on Colon Adenoma Surveillance and Adherence to Guideline Recommendations

Summary: This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).
Inclusion criteria: inclusion criteria:

 Any adenoma found on screening/surveillance colonoscopy (ICD9-211.3, Procedure code 45385 or 45380)

 Greater than 18 years old

Exclusion criteria: :

 Less than 18 years old

 Diagnosis of IBD


Study About Patients Using Copper Intrauterine Device

Summary: THE AIM OF THE this study is to assess the hemodynamic changes of uterine artery in patients with CIUD induced bleeding by using transvaginal color Doppler indices (uterine artery resistance index and pulsatility index) to prove the relationship between these changes and bleeding in these patient .
Inclusion criteria: inclusion criteria:

 Regularly menstruating women before CIUD insertion.

 Age between 18 and 35 years.

 Hormonal treatment has not been taken at least two months before the study.

 Non steroidal anti-inflammatory drugs has not been taken 24 hours before the examination.

Exclusion criteria: :

 Pregnancy.

 The presence of pelvic pathology as ovarian cysts, pelvic endometriosis, endometrial polyps or fibrosis.

 Present or past history of pelvic inflammatory disease.

 Patients on hormonal treatment in the last two months before the study.

 Patients on non steroidal anti-inflammatory drugs last 24 hours before the examination.

['Copper Intrauterine Device Induced Bleeding']


A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus

Summary: An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.
Inclusion criteria: inclusion criteria:

 Persons aged 18 and above.

 Persons fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group.

Exclusion criteria: :

 Exclude a history myocardial infarction, angina or stroke.

['Metabolic Syndrome', 'Cardiovascular Risk Factors', 'Systemic Lupus Erythematosus']

Metabolic Syndrome
Cardiovascular Risk Factors
Systemic Lupus Erythematosus


Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide

Summary: This study is being done to look at how well people respond to two very different drug treatments for depression. Clinically, people with depression can respond differently to drug treatments for reasons which are not always clear. Some of our own recent research suggests that people with depression who have a family history of bipolar disorder or completed suicide, may react differently to standard antidepressant medications than those without such a family history. Our data shows that family history of completed suicide, as well as the known predictor of family history of bipolar disorder, may help identify a pre-bipolar high risk group i.e. they currently have depression but at some future date will declare a bipolar illness (manic-depression) by virtue of development of a manic episode also. Our research suggests that treatment- emergent symptoms in response to a trial of antidepressant, such as agitation may be strong predictors of future bipolarity and inherently dangerous particularly as they are not ascribed to the antidepressant treatment. Finally, it is possible that this subgroup of those with depressive illness may respond better and more safely to lithium, a mood stabiliser used in known bipolar depression.~The objective of this proposal is to investigate response to acute lithium treatment in subjects who meet the diagnostic criteria for major depression, but who are potentially at risk for bipolar disorder, by virtue of family history of bipolarity or completed suicide.
Inclusion criteria: inclusion criteria:

 Not currently participating in a drug or medical device clinical trial

 Male or female over the age of 18

 DSM - IV Diagnosis of major depression

 Positive family history of bipolar disorder or completed suicide

Exclusion criteria: :

 Not able to give informed consent

 Pregnant or breast-feeding

 Current additional psychiatric diagnoses including Panic Disorder, Post -Traumatic Stress Disorder (PTSD) or Psychosis

 History of mania or hypomania

 Active substance abuse or dependence in the last 6 months

 Current depressive episode less than 4 weeks or greater than 12 months in duration

 Current or prior adequate trial of lithium or paroxetine

 Current use of other medications such as antidepressants for the treatment of depression

 Clinically significant medical illness, in particular kidney problems


Mental Health First Aid for College Students

Summary: Most college students with mental disorders do not receive treatment, and over 80% of those who die by suicide have never made contact with campus mental health services. Knowledge, stigma, and other health beliefs represent significant barriers to help-seeking for many of these students. However, there have been no large-scale intervention studies for reducing these barriers to mental health treatment on college campuses. This project will fill this gap by determining whether a community mental health education program, Mental Health First Aid (MHFA), is an effective method to increase number of students who seek mental health services on college campuses. MHFA is an international, 12-hour training program that has been shown to increase knowledge of mental illnesses and their treatments, decrease stigma, and increase helping behaviors in community members. However, it has not been tested in a college setting in the United States. To determine the effectiveness of MHFA in US colleges, the proposed project will involve a randomized control trial of the MHFA training program on 32 campuses representing a range of higher education institutions, from community colleges in rural areas to research universities in large, urban areas. The MHFA training program will be administered to peer supports such as residential advisors. Administrative data from campus mental health services and pre- and post-intervention surveys will be used to collect outcome data on service utilization, knowledge, attitudes, and other measures. Data analyses will focus on identifying changes in students' behaviors, knowledge, and attitudes toward mental illnesses that can be attributed to the MHFA training. In addition to testing a novel and timely mental health intervention for college students, this project will result in improved data collection measures for college populations, and will lay the foundation for stronger connections and future collaborations between diverse campus communities. If the MHFA program is successful in reducing stigma and increasing general on-campus awareness and early treatment of emerging mental health problems, then it may provide a cost-effective means for enabling more students to seek early treatments for developing mental health problems.
Inclusion criteria: inclusion criteria:

 Student enrolled in a participating campus as a full-time, residential undergraduate during the 2009-2010 or 2010-2011 academic years. Student must have been living in a participating residence hall.

Exclusion criteria: :

 Students under 18 years of age.

['Depression', 'Anxiety', 'Suicidal Ideation', 'Eating Disorders']

Depression
Anxiety
Suicidal Ideation
Eating Disorders


PERC Rule to Exclude Pulmonary Embolism in the Emergency Deparment

Summary: The Pulmonary Embolism Rule Out Criteria (PERC) is an 8-item rule, that was derived and tested to rule out the diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED) amongst low risk patients. Even though meta analyses have confirmed the safety of its utilization, equipoise remains - especially in European country where the prevalence of PE is higher than in the US- on whether this rule could be safely applied to all low risk emergency patients with a suspicion of PE.~The PROPER Trial is a non inferiority , cluster randomized trial. All centers will recruit patients with a suspicion of PE and a low pre test probability. To rule out the diagnosis of PE, center will use the usual diagnostic strategies with D-dimeres measurement for 6 months, and PERC based strategy for 6 months.~In the control group (usual strategy), patients will be tested for D-dimeres, followed if positive by a Computed Tomography of Pulmonary Artery (CTPA).~In the intervention group (PERC Based), patients will be first assessed with PERC score. If PERC=0, then the diagnosis of PE will be exclude with no supplemental investigations. If PERC>0, then patients will undergo the usual strategy, with D-dimeres measurement +/- CTPA.~The primary outcome is the failure percentage of the diagnostic strategy, defined as diagnosed deep venous thrombosis (DVT) or PE at 3 month follow up, among patients for whom PE has been initially ruled out.
Inclusion criteria: inclusion criteria:

 Acute onset of, or worsening of dyspnea Or chest pain

 Low clinical pretest probability of PE, empiricially estimated by the gestalt.

Exclusion criteria: :

 Other obvious cause than PE for dyspnea or chest pain

 Acute severe presentation

 Contra-indication to CTPA

 Concurrent anticoagulation treatment

 Current diagnosed thrombo-embolic event

 Inability to follow up

 Prisoners

 Pregnancy

 No social security

 Participation in another intervention trial


Glucomannan for the Treatment of Abdominal Pain-related Functional Gastrointestinal Disorders in Childhood

Summary: Background: Functional abdominal pain disorders (FAPD) are common in school-aged children; however, there is no reliable treatment.~Aim: To determine the efficacy and safety of glucomannan for treating FAPD in children.~Trial Setting: Department of Pediatrics, The Medical University of Warsaw.~Intervention: Patients will be enrolled in a double-blind, randomized controlled trial in which they will receive either glucomannan (10g) or placebo for 4 weeks.
Inclusion criteria: inclusion criteria:

 abdominal pain related disorder (functional dyspepsia, irritable bowel syndrome or functional abdominal pain (FAPS) diagnosed according to Rome III criteria.

Exclusion criteria: :

 organic gastrointestinal disease (as established by medical history, complete blood count, urinalysis, stool examination for occult blood, ova and parasites, blood chemistries, abdominal ultrasound, breath hydrogen testing and endoscopy, if needed)

 other chronic disease

 growth failure


Essential Hypotension and Allostasis Registry

Summary: The essential arterial hypotension and allostasis registry is a prospective, observational research that has the purpose of demonstrating that essential blood pressure (BP) disorders and the associated comorbidities are a result of the inappropriate allostatic response to daily life stress. This required a functioning brain orchestrating the evaluation of the threat and choosing the response, this is a mind-mediated phenomenon. If the response is excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify the allostatic pattern, which in turn will play an important role in the development of the comorbidities.~To do so, consecutive patients of any age and gender that visit a cardiologist's office in Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP and allostasis and follow them in time to see what kind of diseases develops the most (including BP) in the follow up according to the categorization of the characteristic chosen and after adjustment for confounder's variables. In addition, stress events with their date are registered.~HYPOTHESIS~The causes of the diseases are multifactorial.~Physical, biochemical, psychological, social, and cultural dimensions of development dynamically interact to shape the health development process.~A person´s health depends on their:~Biological and physiologic systems~External and internal environment (a) physical, b) internal behavioural and arousal state as registered by the brain.~Their interaction.~The allostatic mechanisms to the internal and external stressors (allostatic load) involves a network composed by:~Functional systems; mediated by:~The Autonomic Nervous System~The endocrine system~The immune system~Structural changes: whenever the internal and/or external stressors are long lasting and/or strength enough, they may induce changes in:~Epigenetic, endophenotypes, polyphenism.~Plasticity~The interaction between a) and b).~The network response do not affect exclusively the BP, propitiating the development of comorbidities, which may prompt strategies for prevention, recognition and ultimately, treatment.~The allostatic model defines health as a state of responsiveness.~The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis) and psychological (psychostasis) abilities. It is proposed that both components behave in similar direction and magnitude.~Immune disorders may be associated with the development of cancer. High BP population has a higher sympathetic and lower vagal tone, this has been associated with a decrease in the immune´s system function.~Resources and energy depletion: Terms like weathering have been used to describe how exposures to different allostatic loads gradually scrape away at the protective coating that keeps people healthy. It is postulated that High BP individuals have more resources and energy.
Inclusion criteria: inclusion criteria:

 Any patient regardless of the age of gender

Exclusion criteria: :

 Any non-correctable secondary cause of increase or decrease in blood pressure

 or a pathology that alters the prognosis before the entrance of the patient into this registry.

 nephropathy prior to the admission,

 familial dyslipidemia,

 previous gastric bypass,

 pre-existing heart failure,

 chemotherapy-induced cardiotoxicity,

 arrhythmogenic right ventricular dysplasia,

 long QT syndrome,

 hypertrophic cardiomyopathy

 restrictive cardiomyopathy or sudden death syndromes other than coronary disease

 Down syndrome,

 having one single kidney before entering to this registry,

 polycystic kidney,

 disability to continue with the treatment

 organ transplantation (other than cornea),

 HIV positive,

 homocystinuria,

 myelomeningocele,

 autoimmune diseases,

 paraplegia,

 chronic infections (TB),

 myocarditis of any cause,

 blood dyscrasia with coagulation disorders,

 history of pulmonary embolism,

 sustained or non-sustained ventricular tachycardia,

 idiopathic tachycardia associated with syncope which is not cured by radiofrequency ablation,

 pulmonary hypertension,

 diabetes insipidus,

 COPD,

 Gitelman syndrome,

 Cervical cancer associated with human Papillomavirus,

 multiple sclerosis,

 hemochromatosis,

 not compact ventricle.

 It is important to emphasize that all of these patients, currently excluded from the registry, may be studied in the future, they keep on follow-up and taken 6 BP.

 Additionally it is planned to compare the evolution of patients with secondary causes of hypertension or hypotension with essential disorders

['Fibromyalgia', 'Blood Pressure', 'Depression', 'Panic Attack', 'POTS', 'Inappropriate Sinus Tachycardia', 'Coronary Heart Disease', 'Acute Coronary Syndrome (ACS)', 'Acute Myocardial Infarction (AMI)', 'Cerebrovascular Disease (CVD)', 'Transient Ischemic Attack (TIA)', 'Atrial Fibrillation', 'Diabetes Mellitus', 'Cancer', 'Systolic Heart Failure', 'Diastolic Heart Failure', 'Chronic Fatigue Syndrome', 'Syncope', 'Vasovagal Syncope']

Fibromyalgia
Blood Pressure
Depression
Panic Attack
POTS
Inappropriate Sinus Tachycardia
Coronary Heart Disease
Acute Coronary Syndrome (ACS)
Acute Myocardial Infarction (AMI)
Cerebrovascular Disease (CVD)
Transient Ischemic Attack (TIA)
Atrial Fibrillation
Diabetes Mellitus
Cancer
Systolic Heart Failure
Diastolic Heart Failure
Chronic Fatigue Syndrome
Syncope
Vasovagal Syncope


Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial

Summary: Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of these patients. The application of a protocol for assessing the risk of VTE reduces mortality and morbidity of these phenomena.
Inclusion criteria: inclusion criteria:

 All pregnant women hospitalized.

Exclusion criteria: :

 Previous use of anticoagulation

['Thrombophilia Associated With Pregnancy', 'Perioperative/Postoperative Complications', 'Venous Thrombosis', 'Pulmonary Embolism', 'Other Specified Risk Factors in Pregnancy', 'Deep Vein Thrombosis']


Second-look Endoscopy in High Risk Patients After Endoscopic Hemostasis to Their Bleeding Peptic Ulcers Improves Their Outcomes

Summary: Bleeding peptic ulcer is a common medical emergency. Endoscopic treatment stops bleeding in those actively bleeding from their peptic ulcers, reduces further bleeding, transfusion, surgery and deaths. After initial endoscopic control of bleeding, approximately 10% of them will develop recurrent bleeding. Mortality rate in this group of patients is at least 4 fold higher. In the few who need surgery, mortality approaches 30%. Prevention of further bleeding is therefore a major treatment objective. Currently the investigators use a high dose infusion of proton pump inhibitor (PPI) for 72 hours to render gastric pH neutral. In a previous randomized trial, the investigators showed that the rate of bleeding in 30 days was around 7% with such an approach. In a small subgroup of high risk patients defined by presentation with shock and ulcers > 2 cm in size, 1 in 6 would re-bleed. An alternate strategy is to select those at especially high risk of further bleeding and repeat endoscopic treatment the next morning. The investigators have shown that persistence of major bleeding stigmata, i.e. a visible vessel, during a second endoscopy predicts further bleeding. It is therefore logical that by repeating endoscopic treatment the next morning, the investigators can prevent further bleeding and possibly surgery and deaths. The current study proposes to develop a score to identify those at risk of further bleeding after endoscopy. The investigators used a historical cohort with carefully collected clinical data to derive a risk score. In this derivation phase of 939 patients, the investigators have developed a 9 point risk score which consists of the following parameters (Age>60, Male sex, ulcer>2cm, posterior bulbar in location, spurting or Forrest Ia bleeding and admission hemoglobin of < 8 g/dl). Using AUROC and Youden J statistics, a score of 5 or above has been shown to highly predictive of further bleeding. The score will then be validated in a prospective cohort of patients with bleeding peptic ulcers. In the final phase of this study, the investigators propose a randomized controlled trial to test the hypothesis that a second look endoscopy with treatment in selected high risk patients can further reduce bleeding and improve their outcomes. After endoscopic hemostasis to their bleeding peptic ulcers, patients are risk stratified based on the score. Those with a score of 5 or more are randomized to receive the standard treatment (a high dose PPI infusion) or a second look endoscopy with treatment in addition to PPI infusion. The primary outcome to the trial is further significant clinical bleeding.
Inclusion criteria: inclusion criteria:

 Age >=18

 Informed consent obtained

 Successful endoscopic hemostasis

 Risk Score >= 5

Exclusion criteria: :

 Age < 18

 Pregnancy

 Incomplete endoscopic haemostasis -

['epinephrine injection or heater probe or hemoclips', 'Observation only']


RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke

Summary: The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. Thus, this study will help to expand the information that is available regarding the impact of BoNT-A treatment in routine clinical practice conditions.~Treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. Therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.
Inclusion criteria: inclusion criteria:

 Men or women age 18 years and above

 Post-stroke lower-limb spasticity

 Prior agreement with the patient to inject BoNT-A

 If previously treated with BoNT-A, (at least 3 months interval between last injection and inclusion).

 Therapeutic goals agreed jointly with the patient

 Functional Ambulation Classification (FAC) score 2-5

 Capacity to comply with the protocol

 Written informed consent

Exclusion criteria: :

 Documented positive antigenicity to botulinum toxin

 Neuromuscular disease

 Use of medications that interfere with neuromuscular transmission

 Severe muscle atrophy in any muscle to be injected

 Any other indication that might interfere with rehabilitation or the evaluation of results

 Any non-stroke spasticity diagnosis

 Pregnancy or nursing mothers

 Previous participation in any study using Goal Attainment Scale (GAS)


Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset

Summary: This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.
Inclusion criteria: inclusion criteria:

 80 or less years old patients with acute stroke produced by a main artery occlusion

 NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment)

 Patients receiving EVT or IVT within 4.5 hours after onset

Exclusion criteria: :

 EVT or IVT contraindication

 Previous neurological impairment, severe concomitant disease or poor prognosis.

 Pregnancy or breastfeeding

 Known hypersensitivity to any study drugs

 Severe organic disease for which there is not risk compensation.

['EVT (endovascular treatment )', 'IVT (intravenous thrombolytic therapy)']

EVT (endovascular treatment )
IVT (intravenous thrombolytic therapy)


Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Summary: Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.~The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.
Inclusion criteria: inclusion criteria:

 Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by cesarean section or vaginal delivery

 Diagnosis of TTN

 Parents signed informed consent

Exclusion criteria: :

 Meconium aspiration syndrome

 Respiratory distress syndrome

 Congenital heart disease

 Non respiratory disorders causing tachypnea

['Experimental group: Budicort by Inhalation', 'placebo']


Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

Summary: This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.
Inclusion criteria: inclusion criteria:

 Atrophic vaginitis due to estrogen deficiency

 Post-menopausal
Exclusion criteria:

['Menopause', 'Postmenopausal Vaginal Atrophy']

Menopause
Postmenopausal Vaginal Atrophy


High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure

Summary: Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal bloating and/or jugular venous distention. Assessment of clinical status and serum electrolytes, symptoms and renal function will be performed in accordance to standard of care.
Inclusion criteria: inclusion criteria:

 18 years or older patients with congestive heart failure

 Hypervolemic by at least 2 of the following criteria: 1) Peripheral edema; 2) jugular venous distention greater than 7 cm; 3) radiographic pulmonary edema or pleural effusion; 4) enlarged liver or ascites; 5) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea

 Diuretic resistance as defined by loop diuretic requirements of furosemide greater or equal to 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. ( 1 mg bumetanide = 10 mg torsemide = 20 mg furosemide)

 Estimated glomerular filtration rate (eGFR) of > 30ml/min. according to the MDRD Study equation at the time of admission.

 Female patients of child bearing potential must have a negative urine pregnancy test to be eligible.

Exclusion criteria: :

 Acute coronary syndrome

 Patients with a baseline eGFR < 30 ml/min according to the MDRD equation.

 Baseline potassium serum concentration 5.3 meq/L

 Requirement for intravenous pressors

 Systemic infection

 Patients with concomitant end-stage liver disease

 Significant valvular disease

 Patients with pulmonary embolism

 Patients with high output heart failure

 Pregnant patients


Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis

Summary: The trial is planned as a multicentric, national, phase II, open-label trial to evaluate safety and tolerance of nebulized Liposomal Amphotericin B (Ambisome) for LMA patients during the induction therapy ,intensification, plus Allogeneic Haematopoietic Progenitor Cell transplant in due course, as well for patients diagnosed of several malignant haematologic diseases and treated with Allogeneic Haematopoietic Progenitor Cell Transplant
Inclusion criteria: inclusion criteria:

 Patient has decided voluntary to consent his or her participation signing the consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

 Patients with Acute myeloid Leukemia (AML), that will start induction chemotherapy or those patients submitted to an Allogeneic haematopoietic progenitor cell transplant.

 The patient is >18 years old.

Exclusion criteria: :

 Patient with prior Invasive Pulmonary Aspergillosis (IPA) history.

 History of allergy or hypersensitivity to Amphotericin B.

 Patient with intellectual deficit or patients with psychological alterations that make impossible the trial understanding.

 Pregnancy or breastfeeding.

 Patient has received other investigational drug or non traded product within 30 days before trial beginning.

 Patient is enrolled in another clinical research study or/and is receiving an investigational agent for any reason.

 Patient had major surgery within 4 weeks before enrollment.

['Acute Myeloid Leukemia', 'Allogeneic Haematopoietic Progenitor Cell Transplant']


Pressure Ulcer Prevention in Intensive Care Unit (ICU)

Summary: The study is designed as a randomised controlled trial of trauma patients admitted to the Royal Melbourne Hospital (RMH) Emergency Department (ED) and subsequently transferred to the Intensive Care Unit (ICU). Patients meeting the study inclusion criteria will be randomly allocated to either the control group that will receive usual pressure ulcer prevention strategies or the trial group that will receive usual care plus have a Mepilex Border Sacrum dressing applied to their sacrum and Mepilex Boarder Heel dressing applied to each heel in the ED.~Hypothesis:Patients treated with Mepilex Border dressings will have a lower incidence rate of sacral and heel pressure ulcer development than patients receiving standard care.
Inclusion criteria: inclusion criteria:

 ED and ICU admission for critical illness and/or major trauma Over 18 years old

Exclusion criteria: :

 Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel pressure ulcer Trauma to sacral and/or heel area


Lithium Drug-Drug Interaction Study With Lurasidone HCl

Summary: The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.
Inclusion criteria: inclusion criteria:

 Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.

 Females who participate in this study:

 are unable to have children-OR-

 are willing to remain abstinent from Day -5 until 90 days after discharge;

 Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge.

 Able and agree to remain off of prior antipsychotic medication for the duration of the study.

Exclusion criteria: :

 Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.

 Positive test results within 30 days prior to the start of the study for:

 Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.

 Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up

 Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.

 Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.


Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

Summary: Primary Objective:~- To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI [Cutaneous Lupus Erythematosus Disease Area and Severity Index] activity score is ≥4) concomitant treatment with or without corticosteroid.~Secondary Objectives:~To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid.~To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid.~To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid~To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.
Inclusion criteria: inclusion criteria :

 Patients diagnosed as cutaneous lupus erythematosus (CLE)

Exclusion criteria: :

 Patients receiving corticosteroid more than 15mg/day of the equivalent dose of prednisolone.

 Patients whose CLASI activity scores were less than 4 point at the initiation of Screening (Visit 1) and Day1 (Visit 2) (evaluated by a dermatology specialist).

 Patients whose fluctuations of CLASI activity scores were ≥20% between Visit 1 and Visit 2 (evaluated by a dermatology specialist). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

['Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus']


Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

Summary: This trial will look at the effectiveness and patient acceptance of ultrafiltration therapy in an outpatient setting.~The purpose of this study is to determine if ambulatory patients who suffer from heart failure and hypervolemia can be safely and effectively treated in an outpatient infusion clinic. The results from this trial will be useful in planning a larger, randomized trial comparing usual care and ultrafiltration for this patient population in similar ambulatory settings.
Inclusion criteria: inclusion criteria:

 Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are:

 Older than 18

 Not pregnant

 Have heart failure with worsening hypervolemia despite oral diuretics

 Have at least two of the following signs or symptoms of hypervolemia: JVD, edema >1+, rales pulmonary edema on chest x-ray, orthopnea or PND

 Not more than 10 kg above their usual baseline weight

 Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal

Exclusion criteria: :

 Systolic blood pressure < 90 mmHg

 Serum creatinine > 3.0 mg/dL

 Hematocrit >45 %

 Uncontrolled arrhythmias

 Need for hospitalization

 Require renal replacement therapy

 Contraindication to anticoagulation with heparin

 Poor venous access.

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