Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.

Summary: This was a clinical effectiveness trial designed to compare the effectiveness, safety, and tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with a neuropathic pain component.~Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.
Inclusion criteria: inclusion criteria:

 Informed consent signed.

 Male or female 18 years of age or older.

 Women of childbearing potential must have a negative pregnancy test at the Enrollment Visit.

 Women of childbearing potential must practice medically acceptable methods of birth control during the trial.

 Participant must be appropriately communicative and able to differentiate with regard to location and intensity of the pain, and to complete the questionnaires used in this trial.

 Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months prior to enrollment.

 Participant's pain must require a strong analgesic (defined as World Health Organization Step III) as judged by the investigator.

 Participants who require a washout of co-analgesics at enrolment must have an average pain score (NRS-3) of 5 points or higher. Participants who do not require a washout of co-analgesics at enrollment must have an average pain intensity score (NRS-3) during the last 3 days of 6 points or higher.

 The painDETECT diagnostic screening questionnaire must be either positive (score of 19 to 38 inclusive) or unclear (score of 13 to 18 inclusive). If the participant is being treated with a stable regimen of centrally acting co-analgesics, a negative painDETECT score (score 9 points or higher).

 inclusion criteria prior to allocation to treatment:

 Participants must have an average pain intensity score (NRS-3) during the last 3 days of 6 points or higher.

 Participants must score either positive (score of 19 to 38 inclusive) or unclear (score of 13 to 18 inclusive) on the painDETECT diagnostic screening questionnaire.

Exclusion criteria: :

 Presence of a clinically significant disease or clinical laboratory values that in the investigator's opinion may affect effectiveness, quality of life, or safety/tolerability assessments.

 Presence of active systemic or local infections that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety/tolerability assessments.

 Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members of employees of the investigator.

 Participation in another trial concurrently, or within 4 weeks prior to the Enrollment Visit.

 Known to or suspected of not being able to comply with the protocol and/or appropriate use of the Investigational Medicinal Products.

 Any painful procedures (e.g., major surgery) scheduled during the trial duration (Enrollment Visit until Final Evaluation Visit) that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety assessments.

 Pending litigation or application for insurance/governmental benefits due to chronic pain or disability and/or if the granted benefits might be influenced by a successful participation in the trial.

 Low back pain caused by cancer and/or metastatic diseases.

 History of alcohol or drug abuse, or suspicion thereof in the investigator's judgment.

 Presence of concomitant autoimmune inflammatory conditions.

 Participants with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic active substances.

 Participants with severe renal impairment, i.e., estimated glomerular filtration rate less than 30 mL/min (according to the National Kidney Foundation 2002).

 Known history of clinical laboratory values or current clinical laboratory values reflecting moderately or severely impaired hepatic function.

 History of seizure disorder or epilepsy.

 Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm (including brain metastases if present at the Enrollment Visit). Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting more than 24 hours) or residual sequelae suggesting transient changes in consciousness.

 Pregnant or breast-feeding women.

 Severe respiratory depression with hypoxia and/or hypercapnia, acute or severe bronchial asthma or severe chronic obstructive pulmonary disease.

 Presence or suspicion of paralytic ileus.

 Participants with severe cardiac impairment, e.g., New York Heart Association class >3, myocardial infarction less than 6 months prior to the Enrollment Visit, and/or unstable angina pectoris and/or cor pulmonale.

 Participant with known history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.

 History of allergy or hypersensitivity to tapentadol, oxycodone, naloxone, and their formulations.

 Participants with acute biliary obstruction or acute pancreatitis.

 Participants with hypothyroidism (including myxedema) or Addison's disease.

 Participants taking any prohibited concomitant medication.

['Tapentadol Prolonged Release', 'Oxycodone/Naloxone Prolonged Release']

Tapentadol Prolonged Release
Oxycodone/Naloxone Prolonged Release

['Back Pain', 'Low Back Pain', 'Neuropathic Pain']

Back Pain
Low Back Pain
Neuropathic Pain


Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease

Summary: The purpose of this study is to determine the prevalence of pulmonary embolism in our population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with dyspnea. The patients will undergo investigation for pulmonary embolism, according to current guidelines.
Inclusion criteria: inclusion criteria:

 known or suspected COPD

 COPD-exacerbation

Exclusion criteria: :

 other causes of dyspnea

 unable to perform CT pulmonary angio (contrast allergy, pregnancy)

 already included in the study (each patient included only once)

 use of anticoagulants

['Pulmonary Embolism', 'Chronic Obstructive Pulmonary Disease']

Pulmonary Embolism
Chronic Obstructive Pulmonary Disease


Long-term Oral Esomeprazole for Prevention of Peptic Ulcer Rebleeding in High-risk Patients

Summary: The purpose of this study is to determine whether a long-term prophylactic use of esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole therapy in high-risk patients whose Rockall score ≥ 6.
Inclusion criteria: inclusion criteria:

 Eligible participants included patients ≥20 years who had undergone gastroscopy for melena, haematochezia, or haematemesis due to bleeding peptic ulcers with major stigmata of recent hemorrhage. The major stigmata of recent haemorrhage were classified as Forrest class Ia, Ib, IIa, and IIb. All of the stigmata are given one or a combination of endoscopic therapies, including local injection of diluted epinephrine 1:10000, bipolar heated probe, argon plasma coagulation, band ligation, or hemoclip therapy. Patients will undergo a follow-up endoscopy about 12 to 16 weeks later to confirm that the ulcer has healed to be less than 0.5 cm; otherwise, patients are not enrolled.

Exclusion criteria: :

 Patients are excluded if they had tumor bleeding or ulcer bleeding due to the presence of a Dieulafoy lesion or mechanical factors (e.g, gastrostomy tube induction), comorbid with reflux esophagitis grade C or D, Barrett's esophagus, or marginal ulcer bleeding, hypersensitivity to esomeprazole or any component of the formulation, or had previously participated in the study. Because of concern for patient safety with certain drug-drug interactions, patients who receive anti-platelet therapy, e.g., aspirin, clopidogrel, or others for prophylaxis of established cardiovascular or cerebrovascular diseases will be excluded.

['oral esomeprazole 20 mg twice daily', 'oral esomeprazole 20 mg once daily']

oral esomeprazole 20 mg twice daily
oral esomeprazole 20 mg once daily


The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study

Summary: This study will evaluate the differences in cardiovascular parameters between women with severe preterm preeclampsia and those without preeclampsia using echocardiography and maternal blood. The investigators will also look at associations of abnormal cardiovascular findings and immediate complications among a high risk cohort of pregnant African American women.
Inclusion criteria: Exposed cases:

 inclusion criteria:

 African American women who are admitted to the obstetrical unit with a concern for severe preeclampsia. Patients must be preterm (23-36 6/7 weeks) with a live singleton gestation and at least 18 years old. Women will baseline chronic hypertension and women on magnesium will be included.

Exclusion criteria: :

 Non-African American women, and African women with concern for severe preeclampsia who are admitted 23 weeks or 37 weeks. Women in labor will be excluded. Women with preexisting cardiovascular disease and women who are current smokers will be excluded.

 Unexposed controls:

 inclusion criteria:

 African American women obtaining prenatal care in our outpatient setting who meet matching criteria as noted above.


Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries

Summary: In this study, the postprandial glycemia and insulinemia caused by boiled potato with blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch, is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids and their metabolites is studied in plasma and urine.
Inclusion criteria: inclusion criteria:

 Age 18-45

 Male

 No regular medication

 No participation in a drug trial or blood donation within 2 months

 Non-smoker

 Signs informed consent

 Body mass index 18.5-27 kg/m2

 Fasting plasma cholesterol < 5.5 mmol/l

 Fasting plasma triacylglycerols < 2.6 mmol/l

 Fasting plasma glucose 4-6 mmol/l

 blood pressure <140/80 mmHg

 hemoglobin>130 g/l

 Fasting plasma alanine amino transferase (ALAT) <60 U/l (normal liver function)

 Fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)

 Fasting plasma creatinine <118 µmol/l (normal kidney function)

Exclusion criteria: :

 Regular smoking

 Alcohol abuse

 Regular medication


Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients

Summary: The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms.
Inclusion criteria: inclusion criteria:

 primary OCD diagnosis according to DSM IV criteria

 current symptoms were responsible for significant distress

 previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms

Exclusion criteria: :

 presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol

 current substance dependence or abuse,

 current psychotic symptoms

 current suicide risk

 and current pregnancy or intention to get pregnant before the end of the treatment protocol


Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women

Summary: Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb.
Inclusion criteria: inclusion criteria:

 Women

 Diagnosis of diabetes

 Diagnosis of peripheral arterial disease

Exclusion criteria: :

 Regular physical activity

 Smokers

 Thrombosis active

 Severe peripheral arterial disease

['high-voltage electrical stimulation', 'Kinesiotherapy', 'shortwave diathermy']

high-voltage electrical stimulation
Kinesiotherapy
shortwave diathermy

['Diabetes', 'Peripheral Arterial Disease']


The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis

Summary: Osteoporosis or thinning of the bones affects in 1 in 4 Canadian women and 1 in 8 Canadian men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the number of people afflicted with osteoporosis continues to rise. The most serious complication of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in long hospital stays, dependence on others, and premature death. While there are several medications that prevent osteoporosis they all have side effects. For example, postmenopausal women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and heart disease. In addition, drugs to prevent osteoporosis are expensive and not available worldwide. Therefore, it is essential that researchers continue to identify and test new medications for the prevention of osteoporosis.~The purpose of the research is to determine if nitrates, a group of drugs that are widely available, inexpensive, and commonly used to treat chest pain or angina, can prevent osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely available, inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified. This will improve the health of patients with osteoporosis worldwide.
Inclusion criteria: inclusion criteria:

 Women aged 50 and older

 Lumbar spine BMD (L1 to L4) T score between 0 and -2.0

 At least 3 years postmenopausal

Exclusion criteria: :

 Prior low trauma hip or vertebral fracture

 Total hip or femoral neck T score of <-2.0

 Bone disorders other than osteopenia (e.g., hyperparathyroidism or Paget's disease)

 Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone or an equivalent at 5 mg/d for 12 months or greater, lithium or anticonvulsants

 Alendronate or risedronate use for at least four weeks, within the last three years

 Current treatment with nitrates

 Systolic blood pressure of =<100 mm Hg or diastolic blood pressure >=100 mm Hg at the baseline screening examination

 Abnormal electrocardiogram (ECG) at the baseline screening examination

 history of myocardial infarction, angina, valvular or congenital heart disease

 Disabling conditions that may interfere with follow-up visits

 Inability to give informed consent

 Migraine headaches

 Hypersensitivity to nitrates

['Nitroglycerin ointment 15 mg/day daily for 24 month', 'Placebo ointment daily for 24 month']


Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication

Summary: This is a study aiming to investigate a possible correlation between the parameters affecting the physicians' therapeutic choice with the patients' overall adherence to osteoporosis treatment. Secondary end-points include correlation between the parameters affecting the physicians' therapeutic choice and the patients' quality of life as well as the evaluation of the whole osteoporosis treatment approach of orthopedic surgeons in Greece (diagnostic means, use of diagnostic and treatment guidelines, methodology of follow - up).
Inclusion criteria: inclusion criteria:

 Female patients with postmenopausal osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.

 Male patients ≥ 50 years old with idiopathic osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.

 Male and female patients with steroid-induced osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.

Exclusion criteria: :

 Prior use of teriparatide or PTH(1-84)

 Hypersensitivity to teriparatide regimen.

 Pregnancy and lactation.

 Hypercalcamia.

 Renal deficiency (eGFR < 30 ml/min).

 Other bone metabolic diseases (including hyperparathyroidism and Paget's disease) except primary osteoporosis or steroid induced osteoporosis .

 Uninterpretable increases of alkaline phosphatase (ALP)

 Prior skeletal radiotherapy.

 Skeletal malignancies or bone metastases

['Osteoporosis, Postmenopausal', 'Osteoporosis, Steroid Induced']

Osteoporosis
Postmenopausal
Osteoporosis
Steroid Induced


Personalized Immunotherapeutic for Antibiotic-resistant Infection

Summary: M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. The investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB Biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.
Inclusion criteria: inclusion criteria:

 Adult with decision making capacity afflicted with chronic mycoplasma hominis septic arthritis despite standard treatments.

Exclusion criteria: :

 None

['Infection', 'Immune Deficiency', 'Hypogammaglobulinemia', 'Septic Arthritis', 'Mycoplasma Hominis']

Infection
Immune Deficiency
Hypogammaglobulinemia
Septic Arthritis
Mycoplasma Hominis


The Effectiveness of Interactive Discussion Group Intervention About Suicide Risk Identification and Assessment for Clinical Nurses

Summary: Suicide attempters or people with self-harm have a high percentage in seeking medical services before and after their suicidal or self-harm behaviour compared to general population. Studies revealed that apart from psychiatric services, they were more likely to seek help from doctors of various units (e.g. emergency departments, general medicine, medical-surgical units) across different healthcare systems (i.e. hospitals or district clinics). Besides, suicide event was possibly heard on in-patients of psychiatric or non-psychiatric units. People with self-harm experienced poor communication with healthcare personnel, and they perceived staff's lacking knowledge about suicide as serious problems. In Taiwan it was also found that emergency nurses and general practitioners were in need of improving negative attitudes and enhancing knowledge towards suicidal behaviour. From the point that nurses are the healthcare personnel that spend the most time with in-patients compared to others in the hospital, suicide risk assessment training may enhance nurses' attitudes and ability of risk awareness and assessment towards people with self-harm, which may in turn significantly increase the identification rate of the high risk group for suicide. Currently there is a lack of suicide training program as a reference for nursing education in Taiwan. The study therefore aims to strengthen suicide risk assessment ability among clinical nurses through interactive discussion groups. Using quasi-experimental design with randomized cluster sampling strategy, a case vignettes will be used for suicide risk assessment together with other measurements regarding suicide knowledge and attitudes for both experiment and control groups before and after the training course.
Inclusion criteria: inclusion criteria:

 nurses who work in a variety of wards such as Hematology, Oncology, Stroke and Rehabilitation where potential cases with high suicide risk may be identified.
Exclusion criteria:


Functional Proteomics of Alveolar Macrophages

Summary: The purpose of this study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD).
Inclusion criteria: inclusion criteria:

 COPD, smoker

 COPD, non smoker

Exclusion criteria: :

 none


Development of a Cellular Biomarker for the Diagnosis and Treatment of Diabetic Foot Ulcers

Summary: This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype.
Inclusion criteria: inclusion criteria:

 Male or female, age ≥ 18

 Type 2 Diabetes

 A break in the skin on the foot ≥ 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system

 Hemoglobin A1c ≥ 5.9%

 Ability to provide written informed consent

Exclusion criteria: :

 Any experimental drugs taken orally or topically within 4 weeks of study entry

 Malignant disease at/or in proximity to the DFU

 Target wound of malignant origin

 Failure to satisfy at least one inclusion criterion for one of the two study groups.

['Diabetic Foot Ulcer', 'Type 2 Diabetes']


Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents

Summary: Coronary artery stents have improved the safety and efficacy of percutaneous coronary intervention for coronary artery disease. Drug-eluting stents have been shown to decrease neointimal hyperplasia and to reduce the rate of restenosis and target-lesion revascularization as compared to bare-metal stents. Drug-eluting stents consist of a metallic platform and a therapeutic substance that is usually released from a polymer matrix. A previous study utilizing a bioresorbable polymer has demonstrated a favorable safety and efficacy profile in a large-scale clinical trial as compared to a first-generation druf-eluting stent (LEADERS trial).~The objective of the study is to compare the safety and efficacy of a sirolimus-eluting stent with a biodegradable polymer with an everolimus-eluting stent with a durable polymer in a prospective multicenter randomized controlled non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.
Inclusion criteria: inclusion criteria:

 Age ≥18 years

 Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS

 Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with one or multiple stents

 No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion criteria:

 Pregnancy

 Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Everolimus or contrast material

 Inability to provide informed consent

 Currently participating in another trial before reaching first endpoint

 Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period

['Sirolimus-eluting stent with a bioresorbable polymer (Orsiro)', 'Everolimus-eluting stent with a durable polymer']

['Coronary Artery Disease', 'Angina Pectoris', 'Myocardial Infarction']

Coronary Artery Disease
Angina Pectoris
Myocardial Infarction


The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia

Summary: This study examines how treatment with the drug modafinil, by itself or in combination with cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or diminish the severity of insomnia.
Inclusion criteria: inclusion criteria:

 40 patients aged 25 with insomnia, will be recruited over a 3-6 month interval.

 All subjects will have a stable sleep/wake schedule with a preferred sleep phase between 10:00 PM and 8:00 AM.

 Must live in the Greater Rochester NY area

 All subjects will meet diagnostic criteria for Psychophysiological Insomnia according to the International Classification of Sleep Disorders (ICSD). Criteria are: the complaint of insomnia and impaired daytime function; an indication of learned sleep-preventing associations and somatized tension; active help seeking. The complaint of disturbed sleep will have one or more of the following characteristics: >30 minutes to fall asleep and/or >2 awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes, problem frequency >4 nights/ week, and problem duration >6 months. In addition, all subjects will complain of fatigue and/or sleepiness at intake.

Exclusion criteria: :

 As above


Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers

Summary: In this study, the investigators hypothesize that the use of olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers is feasible in the Philippine setting. It will result in complete ulcer healing or wound closure after 16 weeks.
Inclusion criteria: inclusion criteria:

 Patient is 18 years old or older.

 Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound.

 Patient's target study ulcer/wound is a lower extremity full thickness ulcer/wound not involving tendon, capsule, or bone.

 Patient's target study ulcer/wound and is ≥1.0 cm2 and ≤ 10.0 cm2 in size at the day of initial consult.

 Study ulcer/wound has been present for greater than 6 weeks prior to initial consult.

 Patients with Charcot foot deformities can be entered so long as the Charcot disease is not active, and the ulcer can be offloaded by an orthotic device.

 The patient has adequate circulation to the lower extremity as evidenced by an ABI (measured by Doppler) of ≥ 0.7. If the patient has non-compressible leg arteries, as documented by an ABI >1.3, then the patient must have a Toe-Brachial Index be > 0.6, or a toe pressure >50 mm Hg.

 Patient must have adequate in-home support to comply with all protocol-mandated visits and procedures, offloading or pressure redistribution as required, and proper application of study products and wound care regimen.

 Patient or his/her legal representative has read and signed the Institutional Review Board-approved Informed Consent form before Screening.

Exclusion criteria: :

 An ulcer/wound that is ≥10.0 cm2 and ≤ 1.0 cm2 in size at the day of initial consult is not eligible for this study.

 Patient has clinical evidence of gangrene or infection on any part of the affected foot.

 The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits.

 Patient has clinical evidence of active sepsis or invasive infection (e.g., cellulitis, osteomyelitis).

 Patient has muscle, tendon, or bone exposure in any ulcer bed.

 Patient has known sensitivity or allergy to any component of the study product - Olivamine10.

 Patient has one or more medical condition(s), including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the - Investigator would make the patient an inappropriate candidate for this wound healing study.

 Patient has a malignant disease (other than squamous or basal cell carcinoma of the skin) not in remission for five years or more.

 Patient has known alcohol or drug abuse.

 Patient has a hematocrit greater than 60% or less than 27%.

 Patient's diabetes is under poor control as manifested by HbA1c of >10.0%.

 Patient has clinically significant renal insufficiency or creatinine greater than 2.0 mg/dL.

 Patient has chronic liver disease or clinically significant liver enzyme abnormality as evidenced by elevated AST, ALT, or bilirubin greater than 1.5 times upper limit of normal (ULN).

 Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.

 Patient is using tobacco, or is exposed to a current smoker in their household. Patients may participate in the study if they have not used tobacco for 3 months and have not had a smoker in their household for 3 months.

 Patient is using any form of nicotine including nicotine patches, gums, or sprays.

 Patient has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV).

['Olivamine containing wound care products']

['Ulcer', 'Skin Ulcer', 'Leg Ulcer', 'Diabetic Foot']

Ulcer
Skin Ulcer
Leg Ulcer
Diabetic Foot


Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression.

Summary: Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality from psychiatric illnesses. In 2009, the World Health Organization listed depression as the leading cause of years lost due to disability worldwide. Suicide is the 9th most common cause of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics Canada, 2012) and the 2nd most common cause of death in young people after accidental deaths. This information highlights the importance of finding treatments to prevent suicidal deaths.~Ketamine has been shown to provide rapid treatment response for major depressive episodes both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous infusion which persists for at least 72 hours.~The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT examining these treatments for decreasing suicidal ideation among depressed inpatients with major depressive disorder and bipolar depression.~A total of 52 patients will be recruited for this trial. All subjects will be inpatients at Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or bipolar disorder type I or II currently depressed. Suicidal ideation must be present at baseline assessment in order to be included in the study. Thirteen subjects will be randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the midazolam + TAU in the major depressive stream. Likewise, 26 subjects with bipolar depression will be randomized to these two treatments.
Inclusion criteria: inclusion criteria:

 Provision of written informed consent

 [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI)

 [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI)

 Both females and males, aged 18 to 65 years

 Inpatient status

 Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active

 The ability to understand and comply with the requirements of the study and capable of providing informed consent

 Suffering from suicidal ideation/attempts as evidenced by a score of >0 on either of the SSI or CSSRS or both.

Exclusion criteria: :

 Current or past psychotic symptoms

 Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria

 Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment

 Any pervasive developmental disorder (according to DSM-IV criteria)

 Diagnosis of dementia (according to DSM-IV criteria)

 Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator

 Significant medical condition that would contraindicate the use of ketamine, midazolam or that is untreated and would need urgent attention (as determined by treating physician)

 Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam

 Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator

 Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator

 Pregnancy (or female of child-bearing age not using adequate contraception) or lactation

 A positive β-hCG test at enrollment

 Involvement in the planning and conduct of the study

 Previous enrollment or randomisation of treatment in the present study

 Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements

['Ketamine', 'Midazolam', 'Treatment as usual (TAU)']

Ketamine
Midazolam
Treatment as usual (TAU)

['Major Depressive Disorder', 'Bipolar I Disorder', 'Bipolar II Disorder', 'Bipolar Depression', 'Suicidal Ideation']

Major Depressive Disorder
Bipolar I Disorder
Bipolar II Disorder
Bipolar Depression
Suicidal Ideation


Endoscopic Therapy for Bleeding Marginal Ulcers After Gastric Bypass

Summary: The objective of this study is to identify the incidence rate; describe the risk factors, clinical presentation, and endoscopic treatment; assess the morbidity, mortality, and overall performance of the management of patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.
Inclusion criteria: inclusion criteria:

 patients status post laparoscopic RYGB surgery with active gastrointestinal hemorrhage secondary to marginal ulcer

Exclusion criteria: :

 bleeding marginal ulcers after other bariatric procedures

 staple-line bleeding after RYGB

 iron-deficiency anemia (chronic) secondary to non-actively bleeding marginal ulcer after RYGB

 other sources of GI bleeding different from marginal ulcer such as from staple-lines, complicated PUD, and other surgical and medical causes of GI hemorrhage

 missing records and/or unreachable patients with scant information for analysis


EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care

Summary: Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered. This innovative project will be a template for extending EHR-based clinical decision support to other domains of emergency care to ultimately improve a broad range of pediatric acute care outcomes.~The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain.
Inclusion criteria: inclusion criteria:

 children and adolescents ages 5-20 years with abdominal pain

 internal med, family med, or emergency med trained providers at participating EDs

Exclusion criteria: :

 select comorbid conditions

 previous abdominal surgery

 treated for select comorbid conditions


A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)

Summary: This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.
Inclusion criteria: inclusion criteria:

 Patients with perennial allergic rhinitis meeting all of the followings.

 Patients with symptoms of perennial allergic rhinitis, the severity of which is moderate or severer according to the severity grading provided in the Guidelines for the Management of Allergic Rhinitis in Japan (partly modified) with the 4-nasal symptom score of 4 or over at informed consent and during the pre-treatment observation period

 Patients with positive reaction to the eosinophil count in nasal discharge or nasal challenge test in addition to the skin test or specific IgE antibody test

 Outpatients aged 16 years or over at informed consent

 Patients in either sex

 Patients (or their legal representatives in case of patients aged under 20 years) capable of giving written informed consent

 Patients capable of recording nasal allergy diary every day

Exclusion criteria: :

 Patients with a complication of tuberculous diseases or lower respiratory tract infections, and those with a complication of otorhinolaryngeal infections(acute upper respiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.) requiring treatments judged by the investigator (subinvestigator) at the time of enrollment to randomization

 Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available

 Patients with a complication of recurrent epistaxis

 Patients with uncured nasal septal ulcer, operated nose or nasal trauma.

 Patients with a history of hypersensitivity to steroids and any ingredients of the study drugs

 Pregnant, lactating or possibly pregnant patients or the patients who themselves or whose partners wish to become pregnant during the study

 Patients with severe hepatic or renal disorder, heart or blood disease, diabetes mellitus, hypertension, or other serious complication, suffering from problems with systemic condition

 Patients who have pollens as multiple allergens and the period from 7 days before enrollment to randomization to completion of the treatment period coincides with the period of scattering of relevant pollens

 Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis

 Patients with a complication of a nasal disease (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which may interfere with efficacy evaluation of the study drugs

 Patients with a complication of a disease (acute upper respiratory tract inflammation, acute laryngitis or acute tonsillitis, etc.) of severity affecting nasal symptoms within 7 days before enrollment

 Patients who have previously received MF nasal spray

 Patients who used FP nasal spray within 28 days before initiation of the pre-treatment observation period (7 days before enrollment to randomization)

 Patients who have participated in clinical trials of other investigational product(s) within 120 days (4 months) before obtaining informed consent or participating at present

 Patients in whom prior medication expected to be effective for allergic rhinitis was not drawn long enough before initiation of treatment with the investigational product or the preceding medication cannot be withdrawn

 Patients who are being treated with specific desensitization therapy or nonspecific allassotherapy or in whom such the therapy was withdrawn within 90 days (3 months) before obtaining informed consent (except for patients receiving the maintenance therapy at present in whom the therapy began more than 180 days (6 months) before obtaining the informed consent)

 Other patients whom the investigator or the subinvestigator judged to be inappropriate for participation in the present study

['Placebo for MF', 'Placebo for FP', 'Mometasone', 'Fluticasone']

Placebo for MF
Placebo for FP
Mometasone
Fluticasone


Collection and Testing of Respiratory Samples

Summary: The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., b above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.
Inclusion criteria: inclusion criteria:

 Subjects that sign the Informed Consent form required for prospectively enrolling patients into the study.

 Subjects that present at a hospital, clinic, or physician's office with the signs and symptoms of a respiratory tract infection.

 Subjects with an acute respiratory infection where said acute respiratory infection is suspected of being caused by an Influenza virus.

Exclusion criteria: :

 Subjects where the duration of the symptoms of such an acute respiratory infection is greater than or equal to 5 days (i.e., ≥5).

['QIAGEN ResPlex II Advanced Panel', 'Influenza A', 'Respiratory Syncytial Virus Infections', 'Infection Due to Human Parainfluenza Virus 1', 'Parainfluenza Type 2', 'Parainfluenza Type 3', 'Parainfluenza Type 4', 'Human Metapneumovirus A/B', 'Rhinovirus', 'Coxsackie Virus/Echovirus', 'Adenovirus Types B/C/E', 'Coronavirus Subtypes 229E', 'Coronavirus Subtype NL63', 'Coronavirus Subtype OC43', 'Coronavirus Subtype HKU1', 'Human Bocavirus', 'Artus Influenza A/B RT-PCR Test', 'Influenza B']


Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury

Summary: This study aims to increase understanding of the short-term and long-term outcome of blunt aortic injury (BAI) and to discern if there is an advantage resulting from the type of operative treatment used to manage it, either the classic open surgical repair or a newer technique known as thoracic endovascular repair (TEVAR). Specifically, this study will answer the following questions regarding patients suffering BAI:~What clinical variables affect short-term mortality and neurologic outcome?~What are the long-term treatment-associated complications of open repair and TEVAR?~In patients with a similar injury and physiologic profile, is there a survival advantage resulting from the type of operative treatment?
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of blunt aortic injury (BAI)

Exclusion criteria: :

 Clinical diagnosis of penetrating aortic injury

['Open repair of thoracic aorta injury', 'TEVAR']

Open repair of thoracic aorta injury
TEVAR


Antibiotic/COPD in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation

Summary: Although the use of antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is largely accepted, controversy remains regarding whether the choice of antibiotic has any impact on outcome. Our aim was to compare the effects of the combination of trimethoprim and sulfamethoxazole and ciprofloxacin in patients treated for severe COPD exacerbation requiring mechanical ventilation.
Inclusion criteria: inclusion criteria:

 All patients having a COPD (according to the definition of the American Thoracic Society) and having an acute exacerbation leading to an acute respiratory failure requiring the admission to ICU and mechanical ventilation.

 The acute exacerbation of COPD is defined by increase in the frequency of cough, the volume and the purulence of expectoration and increase of baseline dyspnea. To be included, patients must have respiratory rate >30 cycles/min and one of the following blood gas criteria (with blood gases performed right before the initiation of mechanical ventilation): PaC02 > 6kPa and arterial pH <7.30.

Exclusion criteria: :

 Pneumonia documented with chest radiography

 Antibiotic treatment in the ten previous days of ICU admission

 Former inclusion in the study

 History of allergy to the quinolones and/or to trimethoprim sulfamethoxazole

 Pregnancy or breast feeding

 Severe chronic disease: heart, liver, kidney.

 Known immunodeficiency (malignant hemopathy, AIDS...)

 Digestive disease which could affect the absorption of the drugs

 Concomitant infection which requires systemic antibiotic treatment

['Chronic Obstructive Pulmonary Disease', 'Sepsis', 'Antibiotics']

Chronic Obstructive Pulmonary Disease
Sepsis
Antibiotics


Comparison of CXR and MnDCT

Summary: A comparison of chest x-ray (CXR) and Minimum dose CT (MnDCT) in the acutely ill patient. The hypothesis is that MnDCT is more sensitive than CXR in the detection of acute findings in the acutely ill patient.
Inclusion criteria: inclusion criteria:

 All patients admitted for investigation of acute pulmonary embolus

Exclusion criteria: :

 none


Studio NaVA - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma

Summary: Studio Nava is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. Studio Nava also proposes the innovative use of a web platform (http://nava.ibim.cnr.it/) that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.
Inclusion criteria: inclusion criteria:

 Clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age.

 Controls n°: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology.

Exclusion criteria: :

 Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old


Sleep Plus Eating Routines for Weight Loss

Summary: The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.
Inclusion criteria: inclusion criteria:

 age 21 to 65

 BMI 25 to 45

 sleep 7 hours or less most nights

Exclusion criteria: :

 use of medications affecting sleep

 sleep apnea

 shift work

['Weight Loss Education', 'Sleep and Eating Routine']

Weight Loss Education
Sleep and Eating Routine


Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease

Summary: The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.
Inclusion criteria: inclusion criteria:

 Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease.

 Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight).

 Patients with a fever of 37.5ºC or higher axillary temperature at the time of enrollment.

 Patients to whom the study drug can be administered by day 8 of disease.

Exclusion criteria: :

 Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine within 6 months before the enrollment.

 Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization.

 Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections.

 Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B.

 Patients confirmed to have HIV infection, or patients with a family history of HIV infection.

 Patients who have a history of receiving treatment with infliximab or other biological products.

 Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent.

['TA-650', 'Polyethylene Glycol-treated Human Immunoglobulin (VGIH)']

['Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin']


Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)

Summary: The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia
Inclusion criteria: inclusion criteria:

 Outpatient men or women, age 18 years and above.

 Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.

Exclusion criteria: :

 Known hypersensitivity to Ezetimibe.

 Moderate to severe hepatic insufficiency.

 Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal.

 Pregnancy or lactation.

 Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine

['Primary Hypercholesterolemia', 'Homozygous Familial Hypercholesterolemia']


Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy

Summary: The purpose of this study is to establish whether new techniques that may make polyps (adenomas) stand out better from the background help increase the number of polyps visible at sigmoidoscopy (telescope test to look inside large bowel) compared to looking with standard sigmoidoscopy alone.
Inclusion criteria: inclusion criteria:

 Patients with Familial adenomatous polyposis who have had ileo-rectal anastomosis and had 20 or less adenomas at previous surveillance examination

Exclusion criteria: :

 poor bowel preparation, unable or unwilling to give informed consent, under 18 years of age,those with more than 20 adenoma


A Trial of Levodopa in Angelman Syndrome

Summary: This study is designed to determine whether levodopa will lead to an improvement in the development and tremor in children with Angelman syndrome (AS).~It has been suggested that levodopa, a medication that is usually used to treat Parkinson disease in adults, may help children with AS in their overall development and reduce the tremor that some of them have.~If levodopa is found to be beneficial for children with AS, this could lead to a new treatment for AS.~Funding Source - FDA-OOPD
Inclusion criteria: inclusion criteria:

 Age between 4 years and 12 years (i.e., before the 13th birthday)

 Molecular confirmation of the diagnosis of AS, which may include abnormal methylation studies or UBE3A mutation analyses - only subjects with a molecular diagnosis will be allowed to enroll

 Not on LD, CD, or any dopamine agonists in the 2 weeks prior to participation

Exclusion criteria: :

 Co-morbid disorders that may be associated with developmental or cognitive delays

 Poorly controlled seizures - An average of more than 2 clinical seizures per month in the 12 months prior to enrollment.

 Use of medications that may interact with LD/CD including atypical antipsychotics (aripiprazole, asenapine, iloperidone, olanzapine, paliperidone, risperidone, ziprasidone), monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine), or phenytoin within the last 14 days, or other investigational interventions within the past 3 months

 Presence of cardiovascular disease or instability, respiratory disease, liver disease, peptic ulcer disease, renal impairment, or hematological disorders

 Pregnancy


Does Massage With or Without Aromatherapy Reduce Infant's Distress?

Summary: This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress
Inclusion criteria: inclusion criteria:

 Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery

Exclusion criteria: :

 Neurological impairment

 Eczema or other skin disorders

 Nut allergy


Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

Summary: OBJECTIVES:~I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.
Inclusion criteria: PROTOCOL ENTRY CRITERIA:

 --Disease Characteristics--

 Men aged 18 and over with motor neuron disease, i.e.:

 X-linked spinal and bulbar muscular atrophy (Kennedy's disease)

 Confirmed by androgen receptor, exon-1 mutation genotype

 Amyotrophic lateral sclerosis

 Spinal muscular atrophy

 Significant muscle weakness on manual muscle testing

 No prisoners

 No mental disability
Exclusion criteria:

['Spinal Muscular Atrophy', 'Amyotrophic Lateral Sclerosis', 'Spinobulbar Muscular Atrophy']

Spinal Muscular Atrophy
Amyotrophic Lateral Sclerosis
Spinobulbar Muscular Atrophy


Summary: Childhood Asthma and Schooling: The Truth Unveiled.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of bronchial asthma

 Must be able to swallow tablets

Exclusion criteria: :

 Steroid inhalation or ingestion


Sublingual Administration of PPI

Summary: Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI) among different administration methods: per oral (PO), intravenous (IV), and sublingual (SL).
Inclusion criteria: inclusion criteria:

 Patients with peptic ulcer disease

 Age: 20-75 years old

 Patients who submitted informed consent

Exclusion criteria: :

 Peptic ulcer disease with spurting and oozing

 Shock, hypotension, pregnancy

 Gastrointestinal malignancy


Implications of Pacifier Use in Israeli Children

Summary: The purpose of this study is to examine pacifier sucking habits among children, and to assess implications of the oral habit - for example malocclusions and drooling. The effect of pacifier sucking will be recorded and compared to pacifier type and frequency of use.
Inclusion criteria: inclusion criteria:

 healthy children aged 3-4 years that use a pacifier

Exclusion criteria: :

 children suffering from a chronic or developmental disease that can affect the orofacial region

 finger sucking children children suffering from low muscle tonus, abnormal drooling


Ephedrine vs. Nor Epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section

Summary: The purpose of the study is to determine if norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and morphine. This study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.
Inclusion criteria: inclusion criteria:

 The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2

 Pregnant women with singleton pregnancy

 Gestational age greater than 36 weeks

 Cesarean delivery under spinal anesthesia

Exclusion criteria: :

 Use of cardiac medication or medication for blood pressure control

 Cardiovascular disease

 Multiple gestation

 Gestation diabetes requiring insulin

 Refusal to be in study

 History of chronic opioid use (chronic pain syndrome)

 Emergent caesarean delivery for maternal and/or fetal distress

 Preeclampsia

 Eclampsia

 Progressive neurologic disease

 Infection at insertion site

 Allergy to local anesthetics, narcotics or other study medications

['Anesthesia; Adverse Effect, Spinal and Epidural', 'Hypotension', 'Complications; Cesarean Section']

Anesthesia; Adverse Effect
Spinal and Epidural
Hypotension
Complications; Cesarean Section


Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children

Summary: The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.
Inclusion criteria: inclusion criteria:

 Rheumatic heart disease with recommended strep prophylaxis

Exclusion criteria: :

 less than one year from first diagnosis

 refusal to take the tablets


Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

Summary: The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.
Inclusion criteria: inclusion criteria:

 Have had stereotactic or ultrasound-guided biopsy with marker placement

 Have a lesion or biopsy marker that is visible under ultrasound

 Have surgical target < 6 cm from the skin when lying supine

 Have a discreet surgical target

 Have a lesion in which the center/focal area is defined

 Be at least 18 years of age or older

Exclusion criteria: :

 Have a palpable lesion that does not require localization

 Require more than one localization needle for localization of the surgical target

 Have undergone previous open surgical biopsy or lumpectomy in the operative breast

 Have an implant in the operative breast

 Have a cardiac pacemaker or defibrillator device


Randomized Trial of Amoxicillin Versus Placebo for (Fast Breathing) Pneumonia

Summary: The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia in pre-school children in resource limited settings are controversial both at an individual and public health level. Most infections are viral or self-limiting and non-selective drug treatment has contributed to the global epidemic of antibiotic resistance. There is no high quality trial evidence in managing children with fast breathing in community settings and the WHO itself has called for evidence on which to update guidance. The investigators proposed non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum settings in South Asia to address this deficit.
Inclusion criteria: inclusion criteria:

 History of cough or difficult breathing < 14 days (observed or reported) AND

 Respiratory rate ≥ 50 breaths per minute in children 2 to <12 months (on two consecutive readings by independent physicians) OR respiratory rate ≥ 40 breaths per minute in children12- 59 months (on two consecutive readings by independent physicians) AND

 Written informed consent by a legal guardian

Exclusion criteria: :

 Previously enrolled in study

 Pedal edema

 History of hospitalization in last two weeks

 With severe lower chest wall in-drawing

 Known asthmatics,TB or other severe illness

 Antibiotics taken in last 48 hours

 Bulging fontanel

 Congenital heart disease

 Any surgical condition requiring hospitalization

 Out of catchment area

 Any general danger sign as defined by WHO: Stridor when calm; hypoxia (SaO2 < 90% in air) ; inability to feed; persistent vomiting (after three attempts to feed the baby within ½ hour); convulsions; reduced conscious level


Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension

Summary: AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension.
Inclusion criteria: inclusion criteria:

 Must have completed Visit 14/Week 24 of the NCT00046319 study.

 Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for >=4 weeks following their final study visit.

 Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional criteria:

 Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment.

 Must be stable on conventional therapy for PAH for >=4 weeks prior to the Screening Visit.

Exclusion criteria: :

 Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit.

 Intravenous inotrope use within 2 weeks prior to the Screening Visit.

 Females who are pregnant or breastfeeding.

 Contraindication to treatment with an endothelin receptor antagonist (ERA).


Risk Factors of Minor Head Injury

Summary: Introduction and Aims:~The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.
Inclusion criteria: inclusion criteria:

 Minor head injury, dizziness, nausea, vomiting

Exclusion criteria: :

 no injury to the head

['Minor Head Injury', 'Intracranial Bleeding', 'Traumatic Brain Injury']

Minor Head Injury
Intracranial Bleeding
Traumatic Brain Injury


Osteopathic Treatment in Adult Patients With Cystic Fibrosis

Summary: To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis
Inclusion criteria: inclusion criteria :

 Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene

 Age > 18 years

 Patient with chronic chest , neck or back pain

 Written Informed Consent

 with health insurance

Exclusion criteria:  :

 regular follow-up by an osteopathic physician in the previous 3 months

 patients awaiting lung transplantation

 history of lung transplantation

 pregnancy

 understanding disorders preventing the patient to apply the study

 participation in another clinical interventional study protocol

['Osteopathic treatment', 'Sham Placebo', 'Usual care']

Osteopathic treatment
Sham Placebo
Usual care

['Cystic Fibrosis', 'Back Pain', 'Neck Pain', 'Chest Pain']

Cystic Fibrosis
Back Pain
Neck Pain
Chest Pain


Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease

Summary: The current study will examine the use of a mobile electronic application used to deliver cognitive rehabilitation to patients with mild cognitive impairment due (MCI) due to Alzheimer's disease (AD), and patients with mild AD. Patients will be given a specific cognitive rehabilitation program on their mobile device (iPad) with specific tasks for them to complete. The goal of this study is to determine if a) patients are able to use and adhere to a cognitive rehabilitation program delivered to their mobile device and b) to determine if patients can improve their language, attention, and memory by completing cognitive rehabilitation tasks assigned to them.
Inclusion criteria: inclusion criteria:

 A diagnosis of mild cognitive impairment due to Alzheimer's disease (MCI due to AD) by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association criteria (Albert et al., 2011).

 A diagnosis of mild Alzheimer's disease by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association criteria (McKhann et al., 2011).

 50-90 years of age.

Exclusion criteria: :

 Younger than the age of 50 or older than the age of 90.

 Any self-reported history of substance abuse or alcohol abuse.

 Any self-reported history of prior head trauma (e.g., stroke, traumatic brain injury)

 Any prior self-reported history of significant depression or other mood disorder.

['Memory Disorders', 'Mild Cognitive Impairment', "Alzheimer's Disease"]

Memory Disorders
Mild Cognitive Impairment
Alzheimer's Disease


Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function

Summary: Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of the knee joint is replaced by plastic or metal, has been successful in restoring comfort and mobility to formerly arthritic joints. This study will compare quadriceps muscle strength, knee range of motion, and pain in people who have had a traditional TKA with those who have had a minimally invasive TKA.
Inclusion criteria: inclusion criteria:

 Diagnosis of osteoarthritis

 Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael Dayton (University of Colorado Hospital)

 Minimum of 110 degrees of active knee flexion

 No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10 degrees flexion contracture

 Body mass index less ≤ 40 kg/m2

Exclusion criteria: :

 Any brain, circulation, or heart problems that limit function

 Severe osteoarthritis or other orthopedic conditions that limit function in the lower extremity that is not undergoing the TKA

['Minimally Invasive Total Knee Arthroplasty [TKA Min]', 'Total Knee Arthroplasty (TKA) Traditional']


Plantar Faciitis and Diabetes Mellitus

Summary: Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of Diabetes mellitus

 Must be obese

Exclusion criteria: :

 Previous radiotherapy to the foot,

 previous trauma to the foot (fracture, rupture of tendon),

 rheumatic or vascular diseases,

 malign diseases,

 lymphatic edema.


Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial

Summary: The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of weight gain.
Inclusion criteria: inclusion criteria:

 Are men or women, between the ages of 19 and 65, inclusive

 Have a diagnosis of any type of bipolar disorder or any type of psychotic disorder based on structured diagnostic interview (MINI).

 Are currently outpatients or inpatients and taking a neuroleptic or mood stabilizer medication (listed below) for the past 6 months, and on a stable dose for the past 2 months.

 Have a body mass index > 25.

 No substance use disorder in the past 2 months (except for nicotine or caffeine).

 Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as a barrier method, hormonal contraceptive, or surgical sterilization (females only). All women of childbearing potential must have a negative pregnancy test before beginning study medication.

 Are able to swallow the capsules whole

 Are willing and able to follow Investigator instructions and study procedures, and report adverse events

 Not currently actively suicidal or homicidal.

 No use of topiramate within the last 6 months.

 No medical contraindication to the use of zonisamide.

 List of medications for inclusion criterion #3:

 All conventional neuroleptics. All atypical neuroleptics except aripiprazole or ziprasidone. All forms of valproate. All forms of lithium. All forms of carbamazepine.

Exclusion criteria: :

 Clinically significant renal or hepatic disease.

 History of acute intermittent porphyria, glucose-6phosphate dehydrogenase deficiency or hemolytic anemia.

 Allergy to zonisamide or sulfonamides.

 Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease

 Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities

 Require treatment with any medication (e.g., carbonic anhydrase inhibitors) that might interact adversely with, or obscure, the action of the study drug

 Are pregnant or lactating (females only)

 Have a history of nephrolithiasis

 Refuse to give informed consent

 Have previously enrolled in this study or previously been treated with zonisamide


Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction

Summary: The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.
Inclusion criteria: inclusion criteria:

 Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:

 chest pain suggestive for acute myocardial infarction

 symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia

 ECG with ST-T segment elevation > 1 mV in 2 or more leads

 TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;

Exclusion criteria: :

 Hemoglobin levels > 10.6 mmol/L;

 Anticipated additional revascularisation within 4 months;

 Cardiogenic shock;

 Presence of other serious medical conditions

 Pregnancy/breast feeding

 Malignant hypertension

 End stage renal failure (creatinin > 220 micromol/l)

 Previous treatment with rh-EPO

 Blood transfusion <12 weeks prior to randomisation

 Polycythemia vera

 Previous acute myocardial infarction

 Concomitant inflammatory or malignant disease

 Recent trauma or major surgery

 Unwilling to sign informed consent

 Atrial fibrillation


Cell Therapy in Myocardial Infarction

Summary: The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)
Inclusion criteria: inclusion criteria:

 Patients will be eligible if presenting all characteristics described below:

 ST segment elevation myocardial infarction in two or more contiguous leads, and according to the WHO definition, at least one of the following two:

 i) Presence of chest pain. ii) Elevation of the myonecrosis markers.

 Age between 30 and 80 years old.

 Ejection fraction ≤50% on Echocardiogram (Simpson) and segmentary dysfunction of the infarction area, measured between the 3rd and 5th day post AMI.

 Among patients submitted to thrombolytic therapy, the angioplasty of the related artery should be preferably done up to 24h after thrombolysis, with a maximum deadline of 72h after thrombolysis.

Exclusion criteria: :

 Patients will be ineligible if presenting any of the characteristics described below:

 AMI related artery presenting TIMI < 3 at the moment f cell injection.

 Left Main Coronary Artery Lesion of >50% or multivessel coronariopathy (>70% lesion in vessels with >2,0mm diameter in left anterior descending, circumflex and right coronary territory) indicating the need for CABG or angioplasty with three or more stents implant.

 Coronary anatomy, after thrombolytic reperfusion, presenting no need for angioplasty with stent implant.

 Final Diastolic Pression of the LV higher than 30 mmHg during ventriculography for evaluating EF inclusion criteria for the research protocol (item c of inclusion criteria).

 Cardiac arrest or Killip IV AMI at admission with need of ventilatory support.

 Cardiogenic shock persisting up to the third day after AMI (with need of Intra-aortic balloon pump or vasopressors).

 AMI mechanical complications (ventricular septal defect, papillary muscle rupture, and left ventricular free wall rupture).

 Significant valve disease, defined as aortic stenosis (mean systolic pressure gradient across the aortic valve >50mmHg), mitral stenosis with a valvar area less than 1,5 cm,2 moderate to severe aortic and/or mitral regurgitation.

 Chronic use of immunosuppressive agents.

 > 2,0 mg/dl creatinine or previous dialysis treatment.

 Presence of fever on the past 48h before injection glaring active systemic infection according to ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) sepsis definition.

 Sustained ventricular tachycardia 48h after AMI.

 Illicit drugs abuse or alcohol abuse (based on DSM IV).

 Any co morbidity, with survival impact in two years.

 Myocarditis

 Active liver disease

 COPD in continuous steroids use.

 Hematological disease, neoplasm, bone disease or hemostatic disturbances.

 Inflammatory disease or chronicle infectious disease.

 Presence of definitive implantation of a cardiac pace maker or cardiac defibrillator.

 Impossibility to reach a cells suspension of 100 million mononuclear cells due to cells paucity in the bone marrow aspirate.

['Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation']


LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

Summary: To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.
Inclusion criteria: inclusion criteria:

 Age 18 to 80

 Anterior myocardial infarction with:

 Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new

 CK peak>5 times the upper limit of normal with positive MB bands

 Ejection fraction <=40% or anterior dyskinesis or documented LV Thrombus

 MI onset < 7 days from randomization

Exclusion criteria: :

 Inability to give written informed consent

 Medical conditions that would prohibit discharge within 48 hours with the exception of need for anticoagulation

 Cardiogenic shock, rest angina unresponsive to medical therapy or serious ventricular arrhythmia in the 24 hours prior to randomization

 Patients scheduled for surgical procedure in the next 4 months that would prevent use of enoxaparin or warfarin

 Anemia: Baseline Hgb<=9 gm for women, <=10 gm for men or platelet count<100,000

 Renal insufficiency (creatinine >2.0 mg/dl)

 Serious liver disease as reflected by INR>1.3

 Stroke within past 6 months or a prior documented intracranial or subarachnoid hemorrhage

 Active bleeding or major surgery within 2 weeks prohibiting the use of anticoagulants

 Acute pericarditis

 Women of childbearing potential unless pregnancy test negative

 Cardiac or non-cardiac condition with expected survival< 6 months

 Severe peripheral vascular disease

 Patients who undergo cardiac surgery, including CABG, as a result of their index myocardial infarction

 Allergy to aspirin, heparin or warfarin, pork or pork products

 History of recurrent thromboembolic disease or a history of Protein C, Protein S, antithrombin III deficiency or known bleeding disorder.

 Current use of warfarin or need for chronic anticoagulation

 Current participation in other trials using investigational drugs or devices

 Prior enrollment in this trial

['Coronary Artery Disease', 'Acute Myocardial Infarction']

Coronary Artery Disease
Acute Myocardial Infarction


Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

Summary: The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.
Inclusion criteria: inclusion criteria:

 Women 18-45 years old with iron deficiency anaemia

 haemoglobin level between 85 g/L and 105 g/L

 serum ferritin level < 15 µg/L

 D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation

 Standard diet

Exclusion criteria: :

 - Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,

 Haemochromatosis or iron overload of secondary origin (blood transfusion),

 Long term treatment known to modify iron absorption,

 Gastro duodenal ulcer,

 Inflammatory bowel disease or any digestive disease which could modify iron absorption,

 Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase,

 Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),

 Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.


A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors

Summary: This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.~The study was designed to detect a 50% improvement in median PFS[Progression Free Survival] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred.~Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.
Inclusion criteria: inclusion criteria:

 Well-differentiated advanced/metastatic pancreatic islet cell tumor

 Tumor has shown progression within the past year.

Exclusion criteria: :

 Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues

 Prior treatment with any tyrosine kinase inhibitors or anti-VEGF[Vascular endothelial growth factor] angiogenic inhibitors.

 Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted

['Carcinoma, Islet Cell', 'Carcinoma, Pancreas']


Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children

Summary: Paraffin (kerosene) ingestion in the developing world accounts for a large number of visits to healthcare facilities, especially amongst children. There is no evidence in animals and no good evidence in humans that the use of early antibiotics improves the clinical outcome of paraffin-induced pneumonitis. This randomised placebo-controlled trial will investigate whether the use of early antibiotics affects the clinical course of children with pneumonitis following paraffin ingestion.
Inclusion criteria: inclusion criteria:

 Ingestion in the preceding 24 hours

 Presence of respiratory symptoms and/or signs at presentation

 Informed consent obtained from parent or legal guardian

 Resident within the Red Cross Hospital drainage area and able to come for two follow-up appointments

Exclusion criteria: :

 Asymptomatic and no clinical signs

 Too ill to be excluded from receiving an antibiotic as judged by:

 Requiring more than 2L/min nasal-prong oxygen

 Requiring continuous or intermittent positive airway pressure ventilation

 Fever > 40˚C

 Needing an antibiotic for another reason e.g. otitis media, tonsillitis

 Current antibiotic use, prior to kerosene ingestion

 Allergic to amoxicillin


Interaction in Chronic Obstructive Pulmonary Disease Experiment

Summary: The final purpose of this study is to determine whether bronchodilation and cigarette smoking in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase of cardiovascular disease. The aim of this part of the study is to demonstrate the basic mechanism: Does increased respiratory function after administration of a bronchodilator in patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled cigarette smoke and to short-term biological effects associated with cardiovascular disease?
Inclusion criteria: inclusion criteria:

 COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value).

 Current cigarette smoking (at the time of performing the study).

 Willing to provide written informed consent.

 Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test.

 Registered in one of the recruitment institutes.

Exclusion criteria: :

 COPD gold stage I or IV.

 Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility ≥ 10% of predicted.

 Unable to communicate.

 Physically unable to perform any of the tests.

 Non-COPD respiratory disorders.

 Previous lung-volume reduction surgery and/or lung transplantation.

 Evidence of alcohol, drug or solvent abuse.

 Known α-1 antitrypsin deficiency.

['Tiotropium (Spiriva) + Salbutamol (Ventolin)', 'placebo']

['Chronic Obstructive Pulmonary Disease', 'Cardiovascular Disease', 'Smoking', 'Bronchodilation']

Chronic Obstructive Pulmonary Disease
Cardiovascular Disease
Smoking
Bronchodilation


Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

Summary: EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.
Inclusion criteria: inclusion criteria:

 Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Investigator's Brochure (IB) Pilot Part

 Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following criteria:

 Signed informed consent

 Male or female; ≥ 20 years (at the time of giving consent)

 Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status

 Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin

 Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of ≥50% required if normal range of LVEF is not provided by institution)

 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

 Able to swallow and retain oral medication

 Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study

 Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (I.V) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks

 Willing to complete all screening assessments as outlined in the protocol

 Adequate organ function as defined in Table 2 Baseline Laboratory Values

 Able to be hospitalized for PK analysis during cycle 1

 Life expectancy of at least 12 weeks from the first dose of study treatment)

 Randomized Part

 Subjects eligible for enrollment in the Randomized Part of the study must meet all of the following criteria:

 Signed informed consent

 Male or female; ≥ 20 years (at the time of giving consent)

 Histologically or cytologically confirmed gastric carcinoma with documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue

 Subjects who received one prior regimen for gastric carcinoma and defined as progression disease. The regimen must be containing 5-fluoropyrimidine and/or cisplatin

 Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors)

 Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of ≥50% required if normal range of LVEF is not provided by institution)

 ECOG Performance Status of 0 to 1

 Able to swallow and retain oral medication

 Archived (or Biopsy ) tumor tissue available for FISH testing [Wolff, 2007] in central laboratory

 Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study

 Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (IV) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks

 Willing to complete all screening assessments as outlined in the protocol

 Adequate organ function as defined in Table 2

 Gastrectomy status depending on the result in the Pilot Part

 Life expectancy of at least 12 weeks from the first dose of study treatment

 Table 2 Baseline Laboratory Values

 SYSTEM LABORATORY (VALUES)

 Hematologic:

 ANC (absolute neutrophil count)

 Hemoglobin:

 Platelets (≥ 2.0 × 10^9/L) (≥ 9 g/dL) (≥ 100 × 10^9/L) Hepatic Albumin Serum bilirubin AST and ALT (≥ 2.5 g/dL) (≤ 1.25 x ULN) (≤ 2.5 × ULN without liver metastases) (≤ 5 × ULN if documented liver metastases) Renal Serum Creatinine

 Calculate Creatinine Clearance (see Section 11.3) (≤ 2.0 mg/dL)

 - OR - (≥30 mL/min)

Exclusion criteria: :

 Subjects meeting any of the following criteria must not be enrolled in the study:

 Pregnant or lactating female at anytime during the study

 Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment

 Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2)

 Peripheral neuropathy of Grade 2 or greater

 Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded

 History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible

 Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety

 Life threatening infection

 Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

 Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

 Known history or clinical evidence of central nervous system (CNS) metastasis

 Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines

 Concurrent treatment with an investigational agent within 28 days prior to the administration of paclitaxel and/or lapatinib

 Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel, including polyethoxylated castor oil, alcohol, or lapatinib or their excipients

 Anamnesis or diagnosis of pulmonary disorder, such as interstitial pneumonia, pulmonary fibrosis or serious hypoxia

 Gastrectomy surgery if Pilot Part of the study determines that partial gastrectomy (pylorus spared) or total/partial gastrectomy (pylorus removed) has a significant negative impact upon lapatinib PK and safety profile

 Known history of use of any EGFR agent (except Trastuzumab)

 Prior gastric cancer treatment which included a taxane.


Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Summary: To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
Inclusion criteria: inclusion criteria:

 patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10

 patients whose age at the time of obtaining consent is 12 years or over and 18 years or below

Exclusion criteria: :

 patients with schizophrenia or manic-depressive illness

 patients with insomnia caused by physical diseases

 patients having a history of hypersensitivity to zolpidem

 patients with attention-deficit hyperactivity disorder


A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

Summary: This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.
Inclusion criteria: inclusion criteria:

 Adults aged 18 to 85, inclusive

 Has given written, informed consent

 Has acute illness with onset within previous 7 days

 Has at least 2 of the following symptoms:

 Difficulty breathing or shortness of breath

 Cough

 Production of purulent sputum

 Pleuritic chest pain

 Has at least 2 vital sign abnormalities:

 Fever (> 38°C or < 35°C)

 Hypotension (systolic BP < 90 mm Hg)

 Tachycardia (> 100 beats /min)

 Tachypnea (> 24 breaths /min)

 Has at least one other clinical or laboratory abnormalities:

 Hypoxemia (room air SaO2 < 90% )

 Clinical evidence of pulmonary consolidation

 Elevated WBC count or neutropenia (> 12,000/mm3 or < 4,000/mm3)

 Has new lobar or multi-lobar infiltrates on chest radiograph

 Has CURB-65 risk category 1 to 4. Patients with CURB-65 risk category 1 will be limited to 20% of the total patient population

Exclusion criteria: :

 Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1)

 Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life < 8 hours) antibiotic

 Has aspiration pneumonia

 Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days

 Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis

 Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant

 Has primary or metastatic lung cancer

 Has known bronchial obstruction or a history of post-obstructive pneumonia

 Requires admission to ICU at baseline

 Has empyema requiring drainage

 Infection due to an organism known prior to study entry to be resistant to either treatment regimen

 Has known or suspected infection due solely to an atypical pathogen such as Mycoplasma sp., Chlamydia sp. or Legionella sp. or positive Legionella urinary antigen at baseline

 Absolute neutrophil count < 500 cells/mm3

 Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count

 Patients with a recent bone marrow transplant (in post-transplant hospital stay)

 Patients receiving oral steroids > 40 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation

 Patients with a rapidly fatal illness, who are not expected to survive for 3 months

 Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

 Has participated in another trial of an investigational pharmaceutical product in the 30 days prior to enrollment

 Prior participation in this trial.

['Dalbavancin', 'Linezolid', 'Linezolid Placebo', 'Azithromycin']

Dalbavancin
Linezolid
Linezolid Placebo
Azithromycin


The Effect on Small Airways of Addition of Theophylline as Inducer of Histone Deacilase Activity for Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Treated With Inhaled Steroids and Long Acting Beta Agonists

Summary: Chronic obstructive pulmonary disease (COPD) is a chronic progressive respiratory disorder causing disability with an increasing burden to the patient, his family and to the health services. Treatment of COPD patients depends on the stage of the disease. COPD responds poorly to corticosteroids, in spite of inflammation is a major component in its pathogenesis. A major barrier to therapy of COPD is resistance to the anti-inflammatory effects of corticosteroids. The molecular mechanisms for this corticosteroid resistance are now being elucidated, particularly as the molecular basis for the anti-inflammatory effects of corticosteroids is better understood (12). An important mechanism of corticosteroid resistance in COPD, which is also linked to amplification of the inflammatory process, is a reduction in the critical nuclear enzyme histone deacetylase (HDAC)2 . Since the major changes are at the level of small airways. We will examine the effect of addition of theophylline product to stable COPD patients treated with combined inhaler of inhaled corticosteroids.
Inclusion criteria: inclusion criteria:

 stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up

Exclusion criteria: :

 Heart failure Malignancy Immune suppressed