Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot Ulcers

Summary: This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50 enrolled subjects. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone). Subjects must also provide informed consent and meet all other entry criteria to be enrolled and randomly assigned to receive PluroGel N or PluroGel vehicle.
Inclusion criteria: inclusion criteria:

 Non-hospitalized subjects with Type 1 or Type 2 diabetes mellitus as defined by the American Diabetes Association diagnostic criteria (ADA, 2010). Diabetes may be treated with insulin, oral hypoglycemic agents, diet, or a combination of these therapies. Subjects whose diabetes is considered controlled by diet or medication in the opinion of the physician.

 Males or females at least 18 years old.

 Subjects must be considered by the investigator to be reliable, willing and able to give signed informed consent, and must sign the informed consent form.

 Subjects must have a full thickness (i.e., extending through dermis but not involving tendon, bone, or joint capsule) ulcer on the foot distal to the malleoli with a surface area ≥1 cm2 after the wound has undergone appropriate debridement. Subjects must have localized mild infection of the ulcer, as defined by the IDSA criteria as per Appendix C, with in the PGN1300 Protocol, which the investigator believes would ordinarily be treated on an outpatient basis.

 IDSA mild infection of an ulcer is defined as:

 The presence of ≥2 of the following items:

 Local swelling or induration

 Erythema

 Local tenderness or pain

 Local warmth

 Purulent discharge (thick, opaque to white or sanguineous secretion) Local infection involving only the skin and the subcutaneous tissue. If erythema, must be >0.5 cm to ≤2 cm around the ulcer.

 Diabetic Foot Infection-General Parameters Score of at least 2 must be obtained in order to be eligible for enrollment.

 Diabetic Foot Infection-Wound Size Score of at least 1 must be obtained in order to be eligible for enrollment.

 The diagnosis of mild infection must be confirmed immediately following the Day 0 (Enrollment Visit) debridement, although pre-debridement purulence is to be counted as one manifestation of infection.

Exclusion criteria: :

 Subjects with IDSA-defined moderate infection as per Appendix C, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; osteomyelitis; gangrene; muscle, joint, or bone involvement.

 Subjects with IDSA-defined severe infection as per Appendix C, within PGN1300 Protocol including systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, hyperglycemia, or azotemia).

 Subjects with systemic inflammatory response signs, as manifested by ≥2 of the following :

 Temperature >38°C or <36°C

 Heart rate >90 beats/min

 Respiratory rate >20 breaths/min or PaCO2 <32 mm Hg

 White blood cell count >12 000 or <4000 cells/μL or ≥10% immature (band) forms

 Subjects with local wound complications (e.g., prosthetic materials).

 Subjects currently receiving antibiotic treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.

 Subjects requiring concurrent systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.

 Subjects in whom bone or joint involvement is suspected based on clinical examination (e.g., bone noted visually or by probing) or plain view X-ray.

 Subjects with clinically significant peripheral arterial disease requiring vascular reconstructive surgery. Subjects who are expected to be unable to care for their ulcer because of hospitalization, vacation, disability, etc. during the study period, or are unable to safely monitor the infection status at home.

 Subjects with known active alcohol or substance abuse within the 6 months preceding study entry.

 Subjects who are receiving immunosuppressive agents (other than corticosteroids), radiation therapy, or cytotoxic agents.

 Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).

 Subjects with a systemically immunocompromising disease, such as acquired immune deficiency syndrome or known human immunodeficiency virus infection.

 Subjects who have had an unexplained fever or chills during the week prior to enrollment.

 Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).

 Subjects with any known allergy or other contraindication to any ingredients in the study products.

 Women who are breast feeding, pregnant, or not using contraception unless sterile.

 Subjects who have been taking or expect to be taking any other investigational therapy within the 30 days prior to entry or during enrollment.


Resistant Hypertension in Patients With Type-II-Diabetes Mellitus

Summary: The risk of cardiovascular disease (CVD) in patients with type-II-diabetes mellitus (type-II-DM)is more than doubled and CVD accounts for 70% of deaths in this group of patients.~Hypertension is a major risk factor for CVD in patients with type-II-DM and a major contributor cardiovascular mortality. Uncontrolled- (UH) and resistant hypertension (RH)are more common in patients with type-II-DM, why further bloodpressure (BP) control is needed.~The prevalence of UH and RH has not been examined in a consecutive Danish outpatient population with type-II-DM.~The purpose of this study is to examine the prevalence of resistant hypertension in patients with type-II-diabetes and to examine the characteristics of patients with resistant hypertension as compared to patients with controlled hypertension with regards to arterial stiffness.
Inclusion criteria: inclusion criteria:

 18-80 years, informed consent, hypertension, type-II-diabetes mellitus

Exclusion criteria: :

 Non-compliance, s-creatinin above 200, AFli


Immune Response to Cytomegalovirus

Summary: This study will evaluate immune responses against cytomegalovirus (CMV). About 80 percent of adults have been exposed to this virus. CMV typically remains dormant (inactive) in the body, causing no problems. In people with immune suppression, however, the virus can become reactivated and cause life-threatening pneumonia. The knowledge gained from this study may be useful in developing ways to improve immune responses to CMV in stem cell transplant recipients.~Healthy normal volunteers between 18 and 65 years of age who have been exposed to cytomegalovirus are eligible for this study. Candidates will be screened with a medical history and blood tests. Those enrolled will provide a 30-milliliter (6-tablespoon) blood sample once a week for 4 weeks and a final sample 2 months later. The blood will be used to design a test to detect immune responses against CMV and determine the differences in these responses among healthy individuals.
Inclusion criteria: inclusion criteria:

 Age 18-65

 CMV seropositive

 Informed consent given

Exclusion criteria: :

 CMV seronegative

 Abnormal blood counts (hemoglobin less than 12 g/dl, platelets less than 150,000/ul, absolute neutrophil count less than 1,500/ul, absolute lymphocyte count less than 1,000/ul)

 Known history of heart, lung, kidney, liver, or bleeding disorder

 Diagnosis of HIV infection

 Diagnosis or suspicion of immunodeficiency state

 History of intravenous drug use

 Currently pregnant


Thyroxin Treatment in Sub Clinical Hypothyroidism, on the Apnea Hypopnea Index Score, Lipids and Highly Sensitive CRP

Summary: Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the time-course and effect of treating subclinical hypothyroidism in OSA patients on the respiratory events during sleep is not known.~Subclinical hypothyroidism is associated with an increased risk of coronary heart disease (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism and the effect of thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum high-sensitivity C-reactive protein (hs-CRP), than healthy subjects; however, the effect of levothyroxine is controversial.~This project will help us to know if the treatment of subclinical hypothyroidism will improve the symptoms and reduce the progression of OSA, which may improve patients' quality of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases, etc.) or may even reduce mortality.It will help us to know the effect of subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.
Inclusion criteria: inclusion criteria:

 Patients >18 years old

 With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range

 With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled.

 With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization.

Exclusion criteria: :

 Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization.

 Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c >9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons.

 Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter.

 State of pregnancy, Breast feeding or allergy to levothyroxine.


Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Summary: The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes respiration (CSR).
Inclusion criteria: inclusion criteria:

 Able to understand and sign the informed consent

 Able to comply with visits and follow ups included in this protocol

 Ages 20-85 years

Exclusion criteria: :

 An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.

 Skin rash on the nose or on the maxillary area.

 A history of skin allergy to medical tape, and hypoallergenic tapes.

 A history of skin cancer on the nose or on the maxillary area.

 A history of the base of skull fractures, facial fractures

['Obstructive Sleep Apnea', 'Central Sleep Apnea', 'Mixed Sleep Apnea', 'Cheyne-Stokes Respiration']

Obstructive Sleep Apnea
Central Sleep Apnea
Mixed Sleep Apnea
Cheyne-Stokes Respiration


Determine the Association Between the Level of SCI With Chronic Respiratory Symptoms, Measures of Pulmonary Function, and Respiratory Illness.

Summary: This study is using a standardized method to assess respiratory function in SCI in order to determine the association between level of SCI with chronic respiratory symptoms, measures of pulmonary function, and respiratory illness, both cross-sectionally and longitudinally.
Inclusion criteria: Spinal cord injury of >= 1 year in duration, and no other neuromuscular diseases
Exclusion criteria:


Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers

Summary: RATIONALE: Studying samples of tissue from smokers and non-smokers in the laboratory may help doctors identify and learn more about biomarkers related to cancer.~PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of smokers and non-smokers.
Inclusion criteria: inclusion criteria:

 - Adults > 45 years of age, to be age matched with a previously enrolled cohort of current and ex-smokers with airflow obstruction and moderate atypia on sputum cytology, to be included in the following groups.

 - Non-smoking (less than 100 cigarettes per lifetime) controls >50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction (FEV1 < 75% predicted and FEV1/FVC < 75%) and moderate atypia on sputum cytology.

 - Current smokers with > 30 pack years, no airflow obstruction (FEV1 > 90% predicted) or lung cancer, >50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction and moderate atypia on sputum cytology .

 - No prior history of a head and neck or bronchogenic carcinoma.

 - Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and FDA guidelines.

Exclusion criteria: :

 - Clinically apparent bleeding diathesis.

 - Cardiac dysrhythmia that is potentially life-threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (< 2/minute) premature ventricular contractions are not exclusionary.

 - Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy.

 - Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy.

 - Acute bronchitis or pneumonia within 8 weeks.

 - Inability to give informed consent.

 - Current smokers with no airflow obstruction may not have a history of coughing more than two times /week.

['Lung Cancer', 'Precancerous Condition']


Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Summary: The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children.~For the efficacy asses were compared:~the time to start the action;~the action duration;~the difference between the basal temperature and the lower temperature in the study period.~For the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.
Inclusion criteria: inclusion criteria:

 male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.

Exclusion criteria: :

 patients with a bad general heath state

 patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion;

 intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug;

 moderated or severe dehydration;

 conscience state alteration;

 not capable of ingest oral drugs;

 patients being treated with steroids;

 patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study.


A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

Summary: This investigator initiated study, single-blinded, parallel, randomized study will be conducted in subjects with 2 or more keloids similar in size and duration on a similar area of the body. The response of the closure techniques will be evaluated by clinical and instrumental assessments. Each qualified subject will be assessed and the keloids will be randomly assigned to the Clozex or suture closure. One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex. A second keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures. The inflammation index and the keloid recurrence rate at each surgical wound closure site will be compared.
Inclusion criteria: inclusion criteria:

 Male or females, in good health, and at least 12 years of age.

 Individuals with 2 or more keloids on the trunk, arm, leg, and neck between 0.5 and 2 cm in length.

 Individuals who are willing and able to participate in the requirements of the study, including signing the informed consent.

 In the opinion of the investigator, the 2 keloids can be excised in a similar manner and closed properly with the two techniques and will benefit from the procedure.

 In the opinion of the investigator, the keloid could benefit from surgical procedure.

Exclusion criteria: :

 Individuals with keloids that do not fit into the criteria.

 Individuals who are planning pregnancy, pregnant, or breast feeding.

 Individuals with a history of medical or dermatologic conditions which, in the opinion of the investigator, would put the subject at heightened risk or would limit complicate the study evaluations required by the protocol.

 Individuals who present with excessive body hair in the designed keloid area.

 Individuals with uncontrolled diabetes.

 Individuals with autoimmune disorders (HIV/AIDs, SLE).

 Subjects who have received keloid treatment within one month of the first day of the study.

 Individuals who plan to receive keloid treatment(s) during the study.

 Individuals who are currently taking prescription or over the counter medication or interventions on a regular basis that as part of their mechanism of action, have the potential to mask an inflammatory reaction. Examples of such medications include, but are not limited to, corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), antihistamines, aspirin (81mg or less daily dosage permissible), or other medications that in the opinion of the investigator or designee may expose the subject to heightened risk or complicate the study assessments.


Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure

Summary: Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.
Inclusion criteria: inclusion criteria

 In order to be considered an eligible subject, all of the following entry criteria must be met:

 Subjects must be competent to provide informed written consent. Subjects must sign an IRB/IEC approved informed consent form prior to the initiation of any study procedures.

 Subjects must be 18 years of age or older.

 Subjects must have ischemic or nonischemic cardiomyopathy with symptoms of NYHA Class III or IV chronic heart failure.

 Subjects must have a LVEF of less than or equal to 35%, measured within 60 days of the Screening Visit. LVEF must be assessed by radionuclide ventriculography (MUGA). If the subject has experienced any cardiovascular events, has undergone any interventions, or received any changes in treatment that may have affected LV function since the most recent EF measurement, an LVEF measurement must be completed prior to the subject being randomized.

 Subjects must have a left ventricular end diastolic dimension (LVEDD) of >2.7 cm/m2 as measured by 2-D ECHO within 12 months of the Screening Visit.

 Subjects must be on optimal conventional heart failure therapy (with the exception of a beta-blocker), including an ACEI for at least 30 days prior to the Screening Visit, or the subject must have had a trial of an ACEI and proven to be intolerant, or the subject must be taking an ARB for at least 30 days prior to the Screening Visit or proved to be intolerant. Optimal conventional therapy may also include spironolactone, digitalis glycosides, diuretics, or other vasodilators.

 Subjects must have failed the initiation, or the up-titration, of a beta-blocker drug due to hemodynamic intolerance within 12 months prior to the Screening Visit. Failure to tolerate beta-blockade for hemodynamic reasons is defined as worsening signs and symptoms of chronic heart failure, hypotension accompanied with symptoms, or evidence of organ hypoperfusion, which in the judgment of the treating physician precluded further treatment with the beta-blocker. This beta-blocker intolerance must have been documented prior to Screening, and a narrative description of the intolerance must be approved by Myogen prior to Randomization.

Exclusion criteria:

 Subjects who meet any one of the following criteria will be deemed ineligible for participation in the study:

 Subjects with CHF due to or associated with uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, isolated right-sided heart failure, or primary pulmonary hypertension.

 Subjects who have undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within 60 days prior to the Screening Visit.

 Subjects listed for heart transplantation who are expected to be transplanted within 6 months of randomization.

 Subjects who have had a myocardial infarction within 90 days prior to the Screening Visit.

 Subjects with an ECG recorded at the Screening Visit showing any of the following: 1) evidence of transmural ischemia (dynamic ST elevation or ST elevation associated with ischemic symptoms), or 2) ventricular tachycardia (VT) or premature ventricular complexes (PVCs) associated with symptoms, or 3) VT of greater than or equal to 6 beats

 Subjects with sustained (>15 seconds) VT, unless precipitated by an event such as an acute myocardial infarction, induction by catheter placement, or by an electrophysiology procedure, or addressed by AICD placement.

 Subjects with an AICD that has fired for any ventricular arrhythmia within 90 days of the Randomization Visit.

 Subjects with a documented diagnosis of angina that meets either of the following criteria: 1) angina diagnosed as unstable at any time within the 60 days prior to the Screening Visit or 2) angina is the primary symptom that limits daily physical activity

 Subjects who have had ventricular reduction surgery or cardiac myoplasty.

 Subjects on a mechanical assist device.

 Subjects with evidence of a concomitant disease that may interfere with the natural course of the subject's underlying heart failure for the duration of the trial.

 Subjects having a concomitant life-threatening disease for which their life expectancy is estimated to be less than one year.

 Subjects with uncontrolled insulin-dependent diabetes mellitus with a history of frequent hypoglycemic episodes or frequent hospitalizations for hyperglycemia.

 Subjects on the following concomitant medications at the time of Screening are excluded from participating in the study: 1) Calcium antagonists other than amlodipine or felodipine; 2) Flecainide, encainide, propafenone, sotalol, dofetilide or disopyramide; 3) Subjects receiving i.v. positive inotropic agents within seven days of the Screening Visit or Randomization Visit; 4) Subjects receiving a human BNP, including nesiritide, within seven days of the Screening Visit or Randomization Visit; 5) Subjects receiving oral or i.v. type-III PDE inhibitors within seven days of the Screening Visit or Randomization Visit.

 Subjects with a contraindication to treatment with a positive inotropic agent (defined as a serious adverse event attributed to previous treatment with a positive inotrope).

 Subjects with a known contraindication to beta-blocker therapy. This may include beta-agonist-dependent chronic obstructive pulmonary disease or asthma, a heart rate <55 BPM, the presence of second- or third-degree heart block without an implanted pacemaker, and first-degree heart block with a PR interval >220 milliseconds.

 Subjects with active hepatic (screening serum total bilirubin greater than or equal to 3.0 mg/dL), renal (screening serum creatinine greater than or equal to 2.0 mg/dL), hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease, which in the opinion of the Investigator, may adversely affect the safety and efficacy of the study drug or the life span of the subject.

 Subjects known to abuse or actively abusing alcohol or illicit drugs. Abuse of alcohol is defined as the usual daily intake of more than 100 grams of ethanol per day, or more than approximately 6 twelve-ounce bottles of beer, one 750 mL bottle of wine or 250 mL of 80 proof spirits.

 Subjects with a serum potassium <4.0 mEq/L or >5.5 mEq/L at Screening.

 Subjects with a serum digoxin of >1.2 ng/mL at Screening are excluded.

 Pregnant women and women at risk of becoming pregnant (i.e., not using effective methods of birth control).

 Subjects who have participated in a clinical trial involving another investigational drug or device within 30 days of the Screening Visit or at any time during the study.

 Subjects who have demonstrated noncompliance with previous medical regimens.

 Subjects who are hospitalized at the time of the Randomization Visit and are not hemodynamically stable, or for whom there is an acute cardiac or non-cardiac illness that requires further hospitalization.

['Enoximone', 'Metoprolol succinate', 'Placebo to match enoximone', 'Placebo to match metoprolol succinate']

Enoximone
Metoprolol succinate
Placebo to match enoximone
Placebo to match metoprolol succinate


Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

Summary: This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.
Inclusion criteria: inclusion criteria:

 Age at diagnosis at least 4 years or 5 years (according to the policy of the National Brain Tumour Group) and less than 22 years.

 Histologically proven medulloblastoma, including the following variants(WHO classification - 2000): classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis on MRI - supratentorial, arachnoid of the posterior fossa or spine.

 No clinical evidence of extra-CNS metastasis

 No tumour cells on the cytospin of lumbar CSF. Central Review of CSF cytology is recommended but not mandatory. It will be left to national policy.

 Radiotherapy to start no more than 40 days after surgery.

 Ability to receive twice daily radiotherapy.

 Vital functions within normal range for their age group.

 CTC grades < 2 for liver, renal, haematological and audiological function.

 No medical contraindication to radiotherapy or chemotherapy.

 Written informed consent (and patient assent where appropriate) according to the laws of each participating country. Written informed consent should also be sought for biological studies.

 National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies).

Exclusion criteria: :

 One of the inclusion criteria is lacking.

 Brainstem or supratentorial primitive neuroectodermal tumour.

 Atypical teratoid rhabdoid tumour.

 Medulloepithelioma.

 Ependymoblastoma.

 Large cell médulloblastoma.

 Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF).

 Patient previously treated for a brain tumour or any type of malignant disease.

 Patients who are pregnant.

 Females who are sexually active and not taking reliable contraception.

 Known predisposition to medulloblastoma e.g. Gorlin's syndrome.

['Standard Fractionation Regimen', 'Hyperfractionated Radiotherapy']

Standard Fractionation Regimen
Hyperfractionated Radiotherapy


Lactated Ringer's Solution in Neonates With Feeding Intolerance

Summary: The objective of this study is determining if enteral administration of Lactated Ringer's solution (LR) in preterm infants with feeding intolerance enables for faster advancement of milk feeding than fasting.
Inclusion criteria: inclusion criteria:

 Birth gestational age (GA) between 25 and 32 weeks

 Corrected gestational age less than 34 weeks

 Enteral feeding tolerated at a minimum of 10 ml/kg/day for a minimum of 48 hours

 Severe feeding intolerance, defined as a minimum of one or more of the following signs leading to withholding of milk feedings on two evaluations over 12 to 24 hours:

 Significant increased abdominal girth, as evaluated by the treatment team, with abdominal tenderness

 Visible enlarged bowel loops with abdominal tenderness

 Recurrent emesis leading to withhold feeds

 Gastric residuals in excess of one feeding, recurrent or with growing abdominal girth

 Visible blood in stools without anal etiology

 Documented informed consent for participation in the study

Exclusion criteria: :

 Infants who already reached full enteral feeds for 72 hours, in fact a minimum of 130 ml/kg/day enteral feeds without parenteral supplementation.

 Small for gestational age (SGA) (weight at or less than the 3rd percentile on the Fenton growth chart)

 NEC (Bell's stage II or higher, radiologic evidence of NEC, pneumatosis intestinalis or free intraperitoneal air)or history of NEC

 Gastric or intestinal occlusion (no transit, absent bowel sounds, incessant vomiting, bile stained vomiting or air fluid levels)

 Major congenital malformation

 Septic infants requiring therapeutic antibiotics or antimycotics (infants only on prophylactic antibiotics or antimycotics should not be excluded).

 Patients judged as being too ill to enroll in this study, as defined by a requirement for mechanical ventilation with >50% FIO2

 Patent Ductus Arteriosus requiring ibuprofen, indomethacin or ligature, until one week after the end of treatment

 Intraventricular Haemorrhage grade 3 or 4

 Hypernatremia ≥ 150 mmol/L

['Intestinal Disease', 'Feeding Disorder Neonatal']

Intestinal Disease
Feeding Disorder Neonatal


Phase II Study of STA-2 in Patients With Chronic Stable Angina

Summary: The objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.
Inclusion criteria: inclusion criteria:

 Male or female aged > 20;

 Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction ≥ 3 months before screening;

 Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening (Day -7);

 Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by >20% in total exercise time;

 Female patient who was in the post-menopausal stage or of childbearing potential who:

 used adequate contraception since last menstruation and no plan for conception during the study;

 was non-lactating;

 had negative pregnancy test (urine) within 14 days prior to the study;

 Able to provide written informed consent.

Exclusion criteria: :

 Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;

 Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator;

 Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);

 Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;

 Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) > 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine > 3 mg/dL);

 Patients with severe gastrointestinal illness as judged by the investigator;

 Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).


Hip Fracture Surgery in Elderly Patients

Summary: The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.
Inclusion criteria: inclusion criteria:

 Elderly patient (≥ 75 years)

 Patient with planned hip fracture surgery within 48 hours after the hip fracture

 Patient willing and able to complete the requirements of this study including the signature of the written informed consent

Exclusion criteria: :

 Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or distal femur)

 Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression)

 Brain trauma within 12 months prior to selection, history of stroke with residuals

 Patient suffering from delirium (CAM diagnosis) at selection

 Patient who cannot complete the pre-operative mental tests (CAM and/or MMSE) of this clinical trial

 Patient with Mini-Mental State Examination (MMSE) score < 24 at selection

 Patient known to susceptible to malignant hyperthermia

 Patient with elevated intra-cranial pressure

 Patient with a risk of high oxygen demand

 Patient with recent or ongoing myocardial infarction / damage

 Patient with severe cardiac failure, or patient with severe impaired left ventricular systolic function

 Patient with known severe lung and/or airway disease, or severe chronic respiratory insufficiency, or a sustained homecare oxygen therapy

 Contra-indication (serious illness or medical conditions) for general anaesthesia

 Known allergy or hypersensitivity to any drugs administered during this clinical trial

 Previous participation in this clinical trial

 Participation in another clinical trial within 4 weeks prior to selection

 History of alcohol or drug abuse or psychiatric disorders which would impair the understanding of the necessary information or render medically or legally unable to give written informed consent


Palliative Care of Children With End-Stage Heart Failure

Summary: Palliative care in pediatric oncology and neurology is well described in the literature. There is a lack of information on the care of children terminally ill due to heart failure. A significant number of children are diagnosed with terminal heart failure for which palliative care is required.~Objective:~To describe palliative care of children over one year of age with end-stage heart failure, including need for and types of pain control, hospice use, need for and use of home nursing and quality of life issues.
Inclusion criteria: inclusion criteria:

 Any patient between 1 - 18 years of age (inclusive) Any patient with end stage heart disease Treated at Egleston Hospital, Children's Healthcare of Atlanta Followed by Sibley Heart Center Cardiology

Exclusion criteria: :

 Those who do not meet inclusion criteria


Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD

Summary: Background~Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative treatment. In Switzerland estimated 5-7% of the total population are suffering from this chronic disease. According to current guidelines corticosteroids are part of treatment of acute exacerbations in COPD patients. Several studies suggest that corticosteroids accelerate the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of hospitalization, reduce treatment failure rate and improve clinical outcome. The additional therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The investigators recently published a hospital-based study showing that in patients presenting to emergency departments with acute exacerbation of COPD, a short five day treatment with systemic steroids was not inferior to a conventional 14 day treatment with regard to re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the investigators knowledge no data is available about the minimal necessary corticosteroid dose in an outpatient treatment setting so far.~Aim~The primary aim of this study is to investigate in an outpatient setting, whether a three day treatment with orally administered systemic corticosteroids is non-inferior to a five day treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be reduced by shorter therapy.~Hypothesis~The investigators postulate, that in an outpatient setting, where generally less severe exacerbations are being treated, a three day treatment duration of systemic corticosteroids should be non-inferior to a five day treatment duration with regard to treatment benefits but decrease cumulative corticosteroid exposure.~Design and Setting~This study is going to be performed as a prospective, randomized, double-blind, placebo-controlled, non-inferiority trial in an outpatient setting. Randomization will be performed as block randomization with a 1:1 allocation. The investigators are going to recruit GPs in northwestern and central Switzerland.~Methods~The investigators are going to include patients presenting to GP's with acute exacerbation of COPD. When matching the investigators eligibility criteria and written informed consent is given, patients included in the study are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for either five days (conventional arm) or three days (interventional arm) followed by two days of placebo for the interventional group. Pre-randomized, identically looking, numbered blisters are given to all patients included in the study. Antibiotic treatment (Amoxicillin/Clavulanic acid, 625mg 3/d, for ten days) is given to all patients with a CRP ≥50mg/l, COPD and known diagnosis of bronchiectasis, as well as patients presenting with all three of the following symptoms: change of baseline dyspnea, change of sputum quantity and sputum purulence. Further initial treatment and steroid treatment after inclusion is determined and documented by the GP. Patients will undergo follow-up visits at day three and seven by their GP as well as follow-up phone calls executed by the study center at day 30, 90 and 180.
Inclusion criteria: inclusion criteria:

 Informed Consent as documented by signature

 Age ≥40 years

 History of ≥10 pack-years of smoking (past or present smokers)

 Airway obstruction, defined as FEV1/FVC≤70%

 Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the following:

 Change of baseline dyspnea

 Change of cough

 Change of sputum quantity or purulence

Exclusion criteria: :

 Diagnosis of asthma

 Initial necessity of hospitalization

 Women who are pregnant or breast feeding

 Premenopausal women with insufficient contraception and anamnestic risk for pregnancy

 Severe coexisting disease with life expectancy <6 months

 Diagnosis of tuberculosis

 Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation

 Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

 Participation in another study involving an investigational drug

 Previous enrolment into the current study

['Pulmonary Disease, Chronic Obstructive', 'Adverse Effect of Glucocorticoids and Synthetic Analogues', 'Disease Exacerbation']


Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Summary: In our study the investigators want to evaluate the effects of EFTs (emotional freedom techniques) for reducing incidence of PONV (Postoperative nausea and vomiting). The effects of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced then it will be much valuable adjunct to postoperative management of the patients.~Our hypothesis was Emotional freedom techniques are very useful to reduce the incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
Inclusion criteria: inclusion criteria:

 Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.

 Patients with age range of 25 to 55 years

Exclusion criteria: :

 H/O chronic illness like DM, IHD, CRF, CLD,

 H/O acute or chronic psychiatric or psychological illness.

 H/O APD (acid peptic disease) or regurgitation.

 H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of repeated infection.

 H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid etc. in last one month.

 H/O alcohol intake in last one month.

 Previous hepatobilliary surgery.

 Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to open cholecystectomy.

 Patients who are given opioids in postoperative period.

 Patients who need epidural analgesia in postoperative period.

['EFTs (emotional freedom techniques)', 'Tab. Midazolam 7.5 mg', 'Inj. Midazolam 0.7mg/kg', 'Inj. Propofol 2.5mg/kg', 'Inj. Atracurium 0.5 mg/kg', 'Sevoflurane 2.5 vol %', 'Inj. Cefuroxime 1.5 g IV', 'Drug: Inj. Ketorolac 30 mg IV', 'Inj. Zantac 50mg IV']

EFTs (emotional freedom techniques)
Tab. Midazolam 7.5 mg
Inj. Midazolam 0.7mg/kg
Inj. Propofol 2.5mg/kg
Inj. Atracurium 0.5 mg/kg
Sevoflurane 2.5 vol %
Inj. Cefuroxime 1.5 g IV
Drug: Inj. Ketorolac 30 mg IV
Inj. Zantac 50mg IV


Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder

Summary: Children who have parents with bipolar disorder are at risk for developing anxiety disorders.
Inclusion criteria: inclusion criteria:

 10-17 years old

 At least one parent with bipolar disorder

 Meets clinical criteria for a specific anxiety disorder

 PARS -5 item scale score > 10 at screening and baseline of initial study phase

 Fluent in English;

 Provision of written informed consent/assent

 Agrees to participate in 75% of sessions

Exclusion criteria: :

 CANNOT Have any of the Following:

 Documented diagnosis of mental retardation or IQ <70

 Previous participation in mindfulness-based treatment

 Substance use disorder within last 3 months

 Judged clinically to be suicide risk

 Concurrent treatment with psychotropic medication (certain exceptions apply, ask for details)

 Psychotherapy initiated within 2 months prior to screening or plan to initiate psychotherapy during study participation

 Any lifetime diagnosis of bipolar disorder, cyclothymia, schizophrenia, or other psychotic disorder

 Any symptom that requires admission to an inpatient psychiatric unit

 Anxiety symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol


Postoperative Delirium in Hip Arthroplasty Patients

Summary: Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Delirium assessment through standardized questionnaires will be done at baseline (day of the surgery - pre operatory), immediately after surgery (in post anesthesia care unit) and then every 12 hours in Day 1 and Day2 after surgery. The investigators will use linear mixed models to describe the change patterns overtime, and compare differences at each time point. Inflammatory biomarkers will be explored overtime as well. The investigators will also explore age effect on cognitive function - cognitive reserve - based on the score of the cognitive test administered at baseline.
Inclusion criteria: inclusion criteria:

 Male or female, between 30 and 80 years of age

 ASA I , II or III

 Capable and willing to consent

 Participants literate in English language

Exclusion criteria: :

 ASA IV or V

 Patients with severe visual or auditory disorder

 Illiteracy

 Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia

 Dementia of Alzheimer's type

 Parkinson disease

 Multiple Sclerosis (MS)

 Vascular dementia

['miRNA Testing, Microemboli Monitoring, Delirium Assessment']

miRNA Testing
Microemboli Monitoring
Delirium Assessment


Women's Health Habits Study

Summary: The purpose of this randomized trial is to test the effectiveness of screening and brief intervention for risk drinking by nonpregnant women with specific medical problems exacerbated by excessive alcohol consumption. The medical problems are female factor infertility, hypertension, diabetes, and osteoporosis, conditions that are costly to treat and difficult to manage. Just as pregnant women are thought to be highly motivated to modify their alcohol consumption, so women with specific medical problems worsened by alcohol intake are an appropriate group to receive a brief intervention.
Inclusion criteria: inclusion criteria:

 - 1. has diabetes, hypertension, osteoporosis, or infertility 2. Not currently receiving treatment for alcohol or drug problems or substance related medical illness 3. Not currently experiencing physical dependence on alcohol, requiring medically supervised detoxification 4. Not currently abusing or physically dependent on opiates, cocaine, or other illicit drugs 5. Not currently pregnant. Subjects with infertility may become pregnant during the course of the study.

 6. Not currently nursing. 7. Able to complete study measures.

Exclusion criteria: :

 Alcohol screen negative or drinks within NIAAA sensible drinking limits for women

 Does not agree to randomization and study terms

['Brief Intervention', 'Diagnostic assessment']

Brief Intervention
Diagnostic assessment

['Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility']

Risk Drinking,Diabetes
Hypertension
Osteoporosis
Infertility


Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.

Summary: The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.
Inclusion criteria: inclusion criteria:

 Patient over 18 years old who has provided his/her written informed consent

 Patient who can be monitored by the same investigation team throughout the duration of the study

 Patient who agrees to wear effective venous compression every day, associated with the trial dressing

 Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3

 Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2

 Ulcer duration between 3 and 36 months

 Ulcer where the surface area is 70% or more covered by fibrinous tissue

 Ulcer at least 3 cm away from any other lesion

 Ulcer moderately or strongly exudative justifying the use of an absorbent dressing

Exclusion criteria: :

 Female patient of child-bearing potential who has no effective means of contraception

 Patient who is pregnant or breastfeeding

 Patient taking part in another therapeutic trial

 Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid)

 Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment

 Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy

 Patient with a systemic infection not controlled by suitable antibiotic treatment

 Patient who, during the 3 months before inclusion, presented a deep vein thrombosis

 Ulcer where its surface is totally or partially covered by black necrotic plaque

 Ulcer which is clinically infected

 Ulcer requiring surgical treatment or for which surgery is programmed during the six weeks following inclusion

 Malignant ulcer


Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis

Summary: A Pilot study~Randomized and Double-blinded~Placebo controlled~In 2 parallel group (JOINS 200mg:Placebo = 1:1)~Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months)~Provide rescue medicine throughout whole clinical trial period.
Inclusion criteria: inclusion criteria:

 A female is eligible if she is of:

 Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal

 Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly

 Pregnancy test result of negative at screening

 Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria.

 ACR Criteria : With Knee pain and satisfied at least 1 of 3 (① age > 50 years, morning stiffness < 30 minute, ③ Presence of Crepitus and Osteophytes on motion)

 Appropriately signed and dated informed consent has been obtained

Exclusion criteria: :

 Rheumatoid arthritis or inflammatory arthritis.

 Bilateral total knee replacement already treated, or planning for the procedure.

 Knee prosthesis already implanted, or foreseen within the next year.

 Clinically significant hip osteoarthritis.

 Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula).

 Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.).

 MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc,.

 Allergic reaction to Clinical trial medication.

 Other clinical trial drugs during the 1 month prior to the screening visit.


Infection, Sepsis and Meningitis in Surinamese Neonates

Summary: Suriname is a small developing country in South America with a population of half a million people. Early neonatal death in Suriname is high with 16 per 1000 live births. Unpublished data from the Suriname Perinatal and Infant Mortality Survey estimate contribution of infection to early neonatal mortality at 25% (4 per 1000 live births) of all deaths. In comparison, incidence rates of neonatal sepsis alone are 3.5 per 1000 live births. These numbers indicate an increased burden of neonatal infection in Suriname versus the U.S. In any case about 40 newborns that die each year of infection are a huge loss, also considering the small Surinamese community. Despite this overall idea on the impact of infectious disease in Surinamese neonates exact information regarding incidence, type of infection (e.g., localized, viral, early-onset or late-onset sepsis), risk factors (e.g., insufficient antenatal care, maternal Group B-Streptococcus status), etiology, microbial causes, morbidity, antibiotic treatment (type and duration), and epidemiological determinants (e.g., gestational age, sex, ethnicity) are lacking.~From a clinical perspective, there is still a challenge to identify neonates with infection. Neonates are often admitted with ambivalent clinical symptoms and receive preventive antibiotics that are costly, promote pathogen-resistance, and have negative long-term effects (i.e., on the development of the intestinal bacterial flora). Currently, assessment of blood leukocyte or trombocyte counts and levels of CRP are insufficiently sensitive to be used as biomarkers, while confirmation of actual sepsis or meningitis by positive culture results is relatively rare (0.5-3% in the United States). This complicates decisions on duration of antibiotic treatment and hospitalization significantly, while no other biomarkers exist.~The circulating isoforms of adhesion molecules (cAMs), which mediate interactions of leukocytes with the vascular endothelium, have been proposed as biomarkers for infection and sepsis. During infection they accumulate in the bloodstream as a result of shedding, which represents their removal from cell surfaces of endothelial cells and leukocytes by enzymes called sheddases. Recently, we have reviewed mechanisms behind shedding of cAMs in neonatal, pediatric and adult sepsis. The shedding process reflects a critical and active process in orchestrating interaction between leukocytes and the endothelium for an effective host response, while minimizing collateral tissue damage. As a result, both plasma levels of cAMs and their sheddases are subject to change during infection and sepsis. Additionally, compelling, albeit limited, data suggest changes of levels of cAMs in CSF in adult and pediatric meningitis.~To date, some evidence exists of changes in levels of cAMs during malaria (in children from Malawi) and sepsis, although not sensitive enough to predict outcomes in the clinic. Those levels have never been assessed simultaneously with levels of their sheddases in blood or CSF as a diagnostic tool. We propose that this combined approach may provide more detailed information about the extent of inflammatory activation in neonates.While a balance in levels is maintained under resting conditions or mild (local) infection, it may be perturbed during sepsis or meningitis . Thus, simultaneous measurement of these levels could promote early identification of infection, and may even distinguish between mild infection, systemic infection or meningitis. Currently, manufacturers are rapidly developing Luminex® technology as an advanced, fast, high-throughput and clinically feasible bedside tool for such an approach.~We hypothesize that incidence rates of neonates with infection in Suriname are high. We further hypothesize that, upon signs of infection, the simultaneous measurement of cAMs and their SEs in serum and CSF discriminates between infected and non-infected neonates. We aim to: 1) identify and follow neonates at the Academic Hospital Paramaribo with signs of infection to establish incidence rates of infection, and 2) investigate diagnostic potential of our proposed biomarker combination in these neonates for infection, type of infection (e.g., local (mild), sepsis or meningitis) and outcomes.
Inclusion criteria: inclusion criteria:

 This study aims to include all neonates presenting here and at the high and medium care facilities with clinical signs of infection, sepsis or meningitis (age: 0-1 month) that require infection work up (i.e., laboratory testing and culturing):

 Baseline controls: uncomplicated jaunice, no other signs of infection

 Clinical signs of infection: tachypnea, dyspnea, apnea, grunting, tachycardia, bradycardia, hypotension, poor perfusion, vomitus, abdominal distension, constipation, poor feeding, lethargy, irritability, convulsions, temperature instability, pale, yellow, bleak, petechiae, bruising, bleeding.

Exclusion criteria: :

 Extreme prematurity: gestational below 32 weeks of gestational age

 Extreme dysmaturity: birthweight below 1500 grams

 Maternal HIV or malignancy

['Neonatal Sepsis', 'Neonatal Infection', 'Neonatal Meningitis']

Neonatal Sepsis
Neonatal Infection
Neonatal Meningitis


Myocardial Infarction - Stress Prevention Intervention

Summary: Posttraumatic Stress Disorder (PTSD) is a mental disorder that may occur after someone experiences a traumatic event. Between 10-20% of patients may develop PTSD in response to the traumatic experience of myocardial infarction (MI). PTSD is associated with impaired quality of life, social functioning, and high economic burden to the society. Posttraumatic stress attributable to MI has also been shown to be predictive of poor cardiovascular prognosis, whereby this link might relate to several atherothrombotic processes. Therefore the prevention of PTSD after MI is of high relevance. Guidelines have been published for early interventions to prevent the development of posttraumatic stress after different types of trauma but not in terms of acute MI as a traumatic event.~The overarching aim of the planned trial is to test whether a minimal behavioral intervention performed shortly after acute MI in patients at a high risk to develop PTSD and in the setting of a coronary care unit reduces the development of posttraumatic stress.~The primary hypothesis is that posttraumatic stress levels at the 3-month follow-up will be at least 20% lower in the intervention group than in the control group, and that this effect will last up to 12 months after the intervention. The secondary hypothesis is that the intervention group will show better psychosocial functioning, and a more favourable cardiometabolic biomarker profile than the control group 3 and 12 month after the intervention.
Inclusion criteria: inclusion criteria:

 Age over 18 years

 STEMI (ST-elevated myocardial infarction) or non-STEMI

 Stable circulatory condition

 Numeric Rating Scale (NRS) (0-10): a score of at least 5 for pain (during MI) plus a score of at least 5 for fear of dying (until admission to the CCU) and/or making sorrows and feeling helpless (when being told about having MI)

 Written informed consent

Exclusion criteria:

 Participating in any other randomized-controlled trial run by the Cardiology Department of the University Hospital of Bern

 Emergency coronary artery bypass graft surgery

 Comorbid serious disease likely to cause death within 1 year

 Current clinically severe depression

 Not fully oriented to the situation, person, and place

 Cognitive impairment according to an adapted short version of the Mini-Mental State Examination

 Insufficient knowledge of German language in reading and understanding

 Affirmation of suicidal ideation in the last two weeks

['Minimal behavioral intervention', 'Control intervention']

Minimal behavioral intervention
Control intervention

['Stress Disorders, Post-Traumatic', 'Myocardial Infarction']

Stress Disorders
Post-Traumatic
Myocardial Infarction


Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

Summary: The purpose of this study is to assess the direct effects of the ten-valent pneumococcal conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.~These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011.~Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder non-vaccinated siblings aged 5 to 9 years.
Inclusion criteria: inclusion criteria for FinIP-vaccinated children:

 age 3 to 5 years

 enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1)

 at least one parent with fluent Finnish

 informed consent from one parent

Exclusion criteria:  for FinIP-vaccinated children

 PCV vaccination administered, other than the randomized study vaccine

 history of antimicrobial treatment within 4 weeks (the child can be enrolled later)

 inclusion criteria for unvaccinated siblings

 age 5 to 9 years

 younger sibling living in the same household having participated in the FinIP trial (regardless of the vaccination schedule)

 at least one parent with fluent Finnish

 informed consent from one parent

['Nasopharyngeal Carriage of Streptococcus Pneumoniae']


Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

Summary: A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. Chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. Current treatment is often ineffective in these patients. To develop new medications the investigators need to understand more about the mechanisms that can lead to excessive coughing.~This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic cough. The investigators hypothesise that that chronic cough patients have a more sensitive cough reflex as a result central nervous system hyper-excitability (central sensitisation). The investigators will measure cough reflex sensitivity before and after administration of ketamine, a medication that blocks an important receptor in the central nervous system.
Inclusion criteria: inclusion criteria:

 Healthy Volunteers:

 Over 18 years old

 Measurable cough reflex sensitivity

 No current or past history of chronic cough or chronic respiratory disease.

 No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip.

 Chronic Cough Patients

 Over 18 years old

 Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease.

 Normal CXR

 Normal lung function

 Measurable cough reflex sensitivity

Exclusion criteria: :

 Recent Upper Respiratory Tract Infection (4 weeks)

 Pregnancy/breast feeding

 Current smokers or ex-smokers with < 6 months abstinence or cumulative history of > 10 packyears

 Diabetes Mellitus

 Opiate or ACE Inhibitor use.

 Any centrally acting medication which has the potential to alter cough reflex sensitivity.

 Significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness.

 Drug or alcohol abuse

 History of allergy or reaction to ketamine of other NMDA receptor antagonists.


Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT

Summary: A prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)
Inclusion criteria: inclusion criteria:

 Must be Age greater than or equal to 18

 Obtain informed written consent.

 Diagnosed with acute pulmonary embolism (PE) (< 14 days)

 Catheter-directed therapy (CDT) was performed to treat acute PE
Exclusion criteria:

['Catheter directed debulking of Pulmonary Embolus']


Physiotherapeutic Intervention in Children With Chronic Functional Constipation

Summary: The purpose of this study is to determine whether physiotherapy is effective in the treatment of the chronic functional constipation in children.
Inclusion criteria: inclusion criteria:

 Less than 2 per week defecation

 Fecal incontinence

 Retentive behavior

 Pain at defecation and

 Hard stools

Exclusion criteria: :

 Medication use (calcium, antacid, diuretic and hematinic)

 Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental delay neuropsychomotor, kidney disease and metabolic diseases)

['diaphragmatic breathing, isometric training of the abdominal muscles and abdominal massage']


Ondansetron for the Treatment of Methamphetamine Dependence - 1

Summary: The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.
Inclusion criteria: inclusion criteria:

 18 years of age. Treatment seeking for meth dependence.

Exclusion criteria: :

 Please contact site director for more details.


Glucose Metabolism, Muscle Mass/Function and Inflammation in the Elderly

Summary: A thorough characterization of glucose metabolism and inflammaging in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. The investigators will correlate patterns of insulin secretion/sensitivity with muscle quality/quantity in diabetic and non-diabetic elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an oxidative/inflammatory signature (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.
Inclusion criteria: inclusion criteria:

 Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the criteria of the American Diabetes Association

 Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP)

 Healthy volunteers: no diabetes, no sarcopenia and none of the
Exclusion criteria:


Comparison of Outcomes Between Early Physical Therapy Intervention and Usual Care Following Anterior Cervical Fusion Surgery

Summary: Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to be effective in reducing neck pain, restoring cervical spinal function and mobility in many types of cervical spine dysfunction. However, the training of stabilizers has not been studied in individuals undergoing cervical spinal surgery, even though these individuals often have problems with residual pain and weakness after the surgery.~Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes between an early PT intervention and usual care in patients who have undergone anterior cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved with early PT intervention.~Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3) research design. The patients following ACF surgery will be randomly assigned in one of the two treatment groups: usual care and early intervention. Three outcome measures will be collected pre-operative for baseline, and then at 6-week and 12-week post-operative follow-up visits, including: (1) deep cervical flexor (DCF) strength as determined by the cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability associated neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3) neck pain level using the numeric pain rating scale (NPRS). In addition, at 6 and 12 weeks, the global rate of change (GROC) scale will be obtained to determine the patient's perception of overall improvement as a result of surgery. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the usual care group will receive only one visit of PT for post-operative instruction. The early intervention group will receive verbal and written instructions for posture and training cervical spine stabilizers in addition to the usual care. The early intervention group also will be asked to perform these exercises at home and keep a log of the exercise.~Data Analysis: Two 2x3 MANOVAs with repeated measures will be used to examine the differences in the CCF strength and the NDI scores between groups and at the three different time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the differences in the NPRS and GROC data over time and between groups.
Inclusion criteria: inclusion criteria:

 Men and women between the age of 30 to 70 years

 Individuals who have consulted one of the five participating spine surgeons and are scheduled for ACF surgery at Texas Spine and Joint Hospital

 Surgical candidates classified as Task Force category III, with neurologic deficit without major structural pathology, or IV, with major structural pathology -

Exclusion criteria: :

 Musculoskeletal or systemic disorders with functional impairments that will limit tolerance of testing.

 Pain greater than 8/10 on the NPRS that often indicates severe pathology and therefore limits testing tolerance.

 Prior cervical spine surgeries.

 More than two level cervical spine surgery planned. -

['early physical therapy intervention', 'usual care']

early physical therapy intervention
usual care

['Cervical Spine Degenerative Disc Disease', 'Fusion of Spine, Cervical Region']


Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax

Summary: The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care.~Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence.
Inclusion criteria: inclusion criteria:

 Male or female.

 Age between 15 and 40 years old.

 First episode of spontaneous pneumothorax.

 Symptomatic (dyspnea or chest pain) or the rim of air is > 2cm on CXR requiring simple aspiration

 Complete or nearly complete and persistent lung expansion immediately following manual aspiration

 Organ Function Requirements:

 Adequate hematological function (Hb > 10 g/dl, ANC > 1.5 x 109/L, platelets > 100 x 109/L)

 Normal renal and hepatic functions: serum creatinine < 1 x ULN, SGPT and SGOT< 2.5 x ULN, alkaline phosphatase < 5 x ULN

 Written inform consent

Exclusion criteria: :

 With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc)

 With hemothorax or tension pneumothorax requiring chest tube insertion or operation

 A history of previous pneumothorax

 A history of previous ipsilateral thoracic operation

 Allergy to tetracycline or minocycline

 Pregnant or lactating patients.

 Other serious concomitant illness or medical conditions:

 Congestive heart failure or unstable angina pectoris.

 History of myocardial infarction within 1 year prior to the study entry.

 Uncontrolled hypertension or arrhythmia.

 History of significant neurologic or psychiatric disorders, including dementia or seizure.

 Active infection requiring i.v. antibiotics.

['Simple aspiration with minocycline pleurodesis', 'simple aspiration']


Withholding Feeds During Red Blood Cell Transfusion and TRAGI

Summary: Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. During the last years, investigators ran retrospective observational studies abut NEC developing within the 48 hours after red blood cell transfusion. In the previous studies, the incidence of transfusion associated NEC (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology clinics, withholding feeds during transfusion is not preferred. But several recent studies show an increase in the incidence of TANEC if the newborn goes on feeding before, during and after the transfusion process, especially if it is fed with a formula. The main aim of this study is to investigate the effect of withholding feeds during transfusion, on the development of TRAGI.
Inclusion criteria: inclusion criteria:

 <32 weeks of gestational age or <1500 gr, >7 days old premature babies.

 Babies which are fed enterally well at the time of tha planning of transfusion.

Exclusion criteria: :

 Babies with severe sepsis signs.

 Babies with severe hypoxia and asphyxia.

 Babies with congenital anomaly or complex cardiac anomaly.

['Withholding feeds', 'feeding during transfusion']

Withholding feeds
feeding during transfusion

['Transfusion', 'Feeding During Transfusion', 'Transfusion Related Acute Gut Injury', 'Necrotising Enterocolitis']

Transfusion
Feeding During Transfusion
Transfusion Related Acute Gut Injury
Necrotising Enterocolitis


Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

Summary: The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis
Inclusion criteria: inclusion criteria:

 Female patients with endometriosis-associated pelvic pain

Exclusion criteria: :

 Pregnant or lactating women

 history or suspicion of hormone dependent tumor

 therapy resistant endometriosis

 need for primary surgical treatment

 any other conditions which forbid the participation.

['Visanne (BAY86-5258, SH T00660AA)', 'Placebo']

Visanne (BAY86-5258
SH T00660AA)
Placebo


Pediatric Appendicitis Pathway Study

Summary: The purpose of this study is to test a standardized approach for children being evaluated for appendicitis in the emergency department. This means that all doctors would use the same approach to diagnose appendicitis in children in the emergency department. This pathway uses two scoring systems to identify patients who are at high and low risks of appendicitis. These scoring systems are based on the patient's symptoms, signs the doctor finds when examining the patient, and their blood tests. The goal of this part of the study is to determine if the investigators' pathway accurately identifies patients who have appendicitis.
Inclusion criteria: inclusion criteria:

 Chief complaint of acute appendicitis

Exclusion criteria: :

 Patients with symptoms greater than 7 days


Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax

Summary: To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
Inclusion criteria: inclusion criteria:

 All patients requiring VATS caused by recurrent, persistent, or contralateral spontaneous pneumothorax as well as by spontaneous hemopneumothorax were eligible for this study.

Exclusion criteria: :

 greater than 50 years of age, with underlying pulmonary disease, previous ipsilateral thoracic operation, allergy to tetracycline or minocycline, and unwilling to receive randomization.


Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

Summary: A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation.~Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.
Inclusion criteria: inclusion criteria:

 Adult recipients of kidney transplants from deceased donors

Exclusion criteria: :

 Former extensive abdominal surgery

 Participation in other studies

['Incidence of Symptomatic Lymphocele After Kidney Transplantation', 'Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks']


Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery

Summary: Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among children and young adults. Deficits in attention and memory are common and persist for years after moderate or severe TBI. The similarity between these symptoms and those of children with AD/HD, the efficacy of methylphenidate in the treatment of AD/HD, and the efficacy of methylphenidate in improving recovery of animals with brain injuries, support the need to study methylphenidate effects in children with TBI. This investigation of methylphenidate in children with moderate to severe TBI aims to: (1) Assess the acute effects of 2 different dosages of methylphenidate on attention and reaction time when the medication is administered to children early in recovery; (2) Assess the ability of 8 weeks of methylphenidate to improve the rate of recovery of cognitive, memory, and attentional skills in children with TBI; (3) Identify the frequency of common methylphenidate side effects in children with TBI.
Inclusion criteria: Moderate to severe traumatic brain injury
Exclusion criteria:


AutoSet for Her Clinical Trial Protocol

Summary: The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.~Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.~User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.
Inclusion criteria: inclusion criteria:

 Pre-menopausal females aged ≥ 18 years

 Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry

 Diagnostic PSG available

 Diagnosis of mild-moderate OSA (AHI ≤ 30)

 Participants willing and able to give written informed consent

Exclusion criteria: :

 Participants currently using Bi-level PAP

 Participants currently using supplemental oxygen

 Participants who are pregnant

 Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)

 Participants who the researcher believes are unsuitable for inclusion because either:

 they do not comprehend English

 they are unable to provide written informed consent

 they are physically unable to comply with the protocol

['Standard AutoSet algorithm', 'Modified AutoSet algorithm']

Standard AutoSet algorithm
Modified AutoSet algorithm


Follow-up Study With Clinical Vitamin D Supplementation Trial on Patients With Depression (DepFuD)

Summary: Depression affects 350 million people worldwide. In the light of the global disease burden statistics, the efficacy of current treatments for depression appears insufficient. Thus, research on novel treatment interventions and predictors for good treatment response are warranted. Earlier prospective follow-up studies and intervention studies suggest that several bio-psychosocial factors, including high serum concentrations of vitamin D, are related to better treatment outcomes. In this follow-up study with randomized clinical vitamin D supplementation trial on patients with depression, the investigators aim to~clarify how a six-month intervention with vitamin D supplementation affects treatment response, recovery, and the biological pathways related to depression. This aims to finding potential sub-groups getting benefits from vitamin D supplementation. In addition, the investigators want to~investigate and characterize factors related to recovery from depression and working ability in depression patients in the long-term. The investigators are especially interested in the bio-psychosocial factors and the aims include examining both the individual's positive resources.~The trial will start with a six-month double-blinded randomized controlled trial with vitamin D supplementation. The aim is to recruit altogether 3028 patients with non-psychotic, unipolar depression, aged 18-65 years, who are referred to the recruitment sites for treatment for depression. The participants will be randomized to low (10 µg/day) or high (100 µg/day) vitamin D supplementation group. Clinically necessary antidepressant treatments will continue during the intervention as needed. After six months of intervention, the participants will be followed up at 18 months and at 5 years.~Several measurements will be conducted during the intervention and follow-up period. Participants will fill a variety of clinical questionnaires and questionnaires with background information. All participants give blood samples for biomarker analyses at time points 3, 6, 18 months and 5 years. Clinical interviews of mental disorders (e.g. SCID) and anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.
Inclusion criteria: inclusion criteria:

 patients referred to the recruitment sites for treatment for depression

 mild, moderate or severe depression,

 mild, moderate or severe episode of recurrent depression

Exclusion criteria: :

 bipolar or psychotic depression

 psychotic disorder

 severe substance abuse

 disabilities in senses that affect functioning and severely threat completing the trial

 diseases that affect vitamin D metabolism (such as sarcoidosis, hypercalcemia, hypofunction of kidney)

 pregnancy or lactation

 current use of high dose vitamin D supplementation

 current use of high dose calcium supplementation

['Vitamin D 10 micrograms', 'Vitamin D 100 micrograms']

Vitamin D 10 micrograms
Vitamin D 100 micrograms


Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

Summary: The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.
Inclusion criteria: inclusion criteria:

 Adult patients with a clinical diagnosis of Graves Disease

 Patients who have selected surgical resection as treatment of their Graves Disease

 Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid

Exclusion criteria: :

 Patients deemed unfit for surgery by operating surgeon or anesthesist

 Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal


TELI TON - Telithromycin in Tonsillitis

Summary: This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.
Inclusion criteria: inclusion criteria:

 Age 6 months to less than 13 years of age (<13);

 Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:

 A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and

 A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs:

 Tonsil and/or pharyngeal erythema and/or exudate;

 Cervical adenopathy;

 Uvular edema;

 Fever

Exclusion criteria: :

 Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough);

 History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P;

 Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis);

 History of rheumatic heart disease;

 Females of childbearing potential (ie, have reached menarche);

 Known congenital prolonged QT syndrome;

 Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm);

 Myasthenia gravis;

 Known impaired renal function, as shown by creatinine clearance ≤25 mL/min

 The subject:

 Is being treated with drugs not permitted by the study protocol ie, cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents, simvastatin, lovastatin and atorvastatin;

 Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;- Has been treated with any investigational medication within the last 30 days;

 Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks.

 History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins;

 Previous enrollment in this study or previous treatment with telithromycin;

 Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.


Quantiferon - Cytomegalovirus (CMV) and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients

Summary: Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.
Inclusion criteria: inclusion criteria:

 Male or female patients who fulfill the following criteria are eligible for inclusion.

 CMV D+/R- liver, kidney, heart, pancreas, lungor combined transplant recipients

 All eligible patients must be scheduled to receive 3 months of either valganciclovir, oral ganciclovir, or intravenous ganciclovir prophylaxis.

 Able to give written informed consent

 Are willing and able to comply with the protocol

 Age >=18 years

Exclusion criteria: :

 - Patient unwilling or unable to give informed consent


Comparative Study of the Effects of Telmisartan and Nebivolol

Summary: Τhe effectiveness of newer angiotensin-II receptor blockers and cardioselective beta-adrenergic blockers in treatment of arterial hypertension and in improvement of arterial stiffness has been established in previous studies among the hypertensive population. The present study is a comparison of the performance of two drugs, telmisartan and nebivolol, in 24h ambulatory blood pressure values and in the degree of arterial stiffness of patients with stage I arterial hypertension.~Measurements will be carried out with the use of 24-h ambulatory blood pressure measurement devices and the method of pulse-wave velocity analysis. The effects of telmisartan and nebivolol are going to be compared for a total time period of 12 months.~The aim of this project is to determine whether the expected decrease in arterial stiffness of subjects with stage I arterial hypertension can be attributed to the blood pressure fall solely, or to other factors as well. These factors are possibly dependent on the action of these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral vasodilatory actions.~The present study is going to be the first comparative test of the anti-hypertensive effects of the two pharmaceutical substances in 12 months' time, and of the elimination of total cardiovascular risk in terms of primary prevention of cardiovascular attacks.
Inclusion criteria: inclusion criteria: The final selection of the sample of 80 patients diagnosed with stage I arterial hypertension will be based on the ABPM results (24h SBP/DBP ≥ 130/80 mm Hg).

Exclusion criteria: :

 Patients who present with normal ABPM values at the end of the 3-month period will be excluded from the study. Subjects diagnosed with white-coat hypertension [increased office BP values (SBP/DBP ≥ 140/90 mm Hg) combined with normal ABPM values (24h SBP/DBP < 130/80 mm Hg)] will also be excluded from the study.

 All subjects with contra-indications for submission of drugs used in the research protocol are going to be excluded from the study. The following categories of patients will not participate in the research: renal failure, hepatic failure, renal artery stenosis, bronchial asthma, vasoconstrictive (Prinzmetal's) angina, hypertrophic cardiomyopathy, aortic valve stenosis, mitral valve stenosis, sinus tachycardia, sinus bradycardia, sick sinus syndrome, Wolff-Parkinson-White syndrome, chronic atrial fibrillation, second and third degree atrioventricular block, right heart failure due to pulmonary hypertension, pheochromocytoma, peripheral artery disease. Pregnant and nursing women will be excluded from the study (history and pregnancy test).