Efficacy of Antifolates Against Malaria in HIV-infected Pregnant Women and the Emergence of Induced Resistance in Plasmodium Falciparum

Summary: Given the resistance emergence of malaria in pregnant women receiving intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this infection among pregnant women infected by HIV it is urgent to seek a more effective alternative treatment to optimize the prevention of malaria. Cotrimoxazole (CTM), actually administered daily as a prophylactic mean to opportunistic infections for HIV infected patients, showed encouraging results in preventing malaria in pregnant women. However, these results must be confirmed by randomized trials, particularly in pregnant women.~The main objective of this clinical trial is to compare the efficacy of cotrimoxazole (CTM), administered once daily with IPT-SP (3 curative doses spaced one month) on placental parasitaemia in pregnant women infected with HIV and cluster of differentiation 4 (CD4) > 350 cells/mm3.~The main hypothesis is based on the premise that cotrimoxazole is more effective than IPT-SP for placental parasitaemia. This might be due to the higher plasma concentration of cotrimoxazole attained with daily doses. If this hypothesis is proven, cotrimoxazole could be recommended as prophylaxis for HIV-positive pregnant women, whatever their CD4+ cell count. In this study, the investigators will also test the hypothesis that the strains of Plasmodium falciparum isolated from HIV-positive pregnant women express more dhfr and dhps resistance markers.
Inclusion criteria: inclusion criteria:

 age ≥ 18 years

 HIV positivity

 gestational age between 16 and 28 weeks

 CD4+ count > 350 cells/mm3 and no sign of WHO stage 2, 3 or 4;

 agreement to attend all the antenatal consultations for the study

 willingness to adhere to all requirements of the study (including HIV-1 voluntary counseling and testing)

 signed informed consent

Exclusion criteria: :

 psychological instability that could interfere with compliance;

 hypersensitivity to sulfamides or dermatological disease(eczema, pemphigoid exanthema) that would increase the risk for severe reactions to the drugs being tested

 severe anaemia (Hb<7 g/dl)and any other severe disease

 known hepatic cardiac or renal disease

['cotrimoxazole daily prophylaxis', 'sulphadoxine-pyrimethamine']

cotrimoxazole daily prophylaxis
sulphadoxine-pyrimethamine

['Malaria in Pregnancy', 'HIV Infection']


Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata

Summary: Alopecia areata (AA) is a common disease of the immune system, known as an autoimmune disease. In the disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Despite many people having this disease, research into its cause and into new, better ways to treat AA has lagged far behind other similar diseases of the immune system. Currently, there are no Federal Drug Administration approved drugs for AA.~Ruxolitinib (made by Incyte) is an intervention known to effectively treat a disease of the bone marrow, known as myelofibrosis. It is also being studied in the treatment of rheumatoid arthritis, another autoimmune disease, by fighting inflammation. There are some genetic and chemical similarities between those with myelofibrosis, active rheumatoid arthritis and AA, suggesting that treatment with ruxolitinib may be effective in AA. In mice specially designed for testing drugs for the treatment of human alopecia areata, this medication worked to prevent the disease AA from starting in mice that would have otherwise developed the disease. To test Ruxolitinib, we are going to treat 12 patients with moderate to severe AA for a minimum of 3 months up to 6 months. This is an open-label study, meaning that there will not be a placebo group; all patients enrolled in the study will receive the active medication. The effectiveness of the medication will be measured by changes in hair re-growth as determined by physical exam and photography, as well as by patient and physician scoring. Patients will be followed for another 3 months off of the drug to see if the effects of treatment last and if there is delayed response. The safety of the medication, ruxolitinib, in patients with alopecia areata will also be evaluated.~Blood work will be collected before medication is started, during the treatment period, and after ruxolitinib is stopped, in order to monitor for adverse effects of the medication. Small scalp biopsies and peripheral blood will be taken at the beginning of the study before treatment and also after 12 and possibly 24 weeks. Optional biopsies may also be taken at additional time points based on clinical considerations. The chemical analysis of these skin samples and blood will help us to understand how the disease happens, how the treatment works, and may even guide us to better treatments in the future.
Inclusion criteria: inclusion criteria:

 Patients between 18 to 75 years of age.

 Patients with a diagnosis of patch type alopecia areata.

 Patients will have >30% and <95% total scalp hair loss at baseline as measured using the SALT score. Two patients with current episodes of alopecia totalis/universalis may be included in this study.

 Duration of hair loss greater than 3 months.

 No evidence of regrowth present at baseline.

 Patients may be naïve to treatment or unresponsive to intralesional (IL) steroids or other treatments for alopecia areata.

Exclusion criteria: :

 Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis.

 Patients in whom the diagnosis of alopecia areata is in question.

 Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma) that in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections.

 Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration.

 Women who are pregnant or nursing.

 Patients known to be HIV or hepatitis B or C positive.

 Patients with history or evidence of hematopoietic abnormality.

 Patients with <200K platelet count at baseline.

 Patients with history or evidence of renal or hepatic impairment.

 Patients with history of immunosuppression or history of recurrent serious infections.

 Patients unwilling or unable to discontinue treatments known to affect hair regrowth in AA.

 Patients taking any medication considered a strong CYP3A4 inhibitor who is unable or unwilling to stop this medication for the duration of the study.

 Patients receiving treatment deemed to affect alopecia areata within 2 weeks to one month of baseline visit depending on the specific treatment.


US Guided Versus BlindI&D for Treatment of Soft Tissue Abscesses in the ED

Summary: Standard treatment for a soft tissue abscess involves incision over the area of maximum fluctuance with drainage of purulence from the abscess cavity. The use of bedside ultrasound to guide this drainage has the potential to improve treatment outcomes by ensuring complete drainage of the cavity.~Our hypothesis is that the use of ultrasound for guidance of incision and drainage of soft tissue abscesses will decrease treatment failure rate compared to standard blind incision and drainage.~This hypothesis will be tested utilizing a blinded, randomized trial comparing standard incision and drainage to ultrasound guided incision and drainage.
Inclusion criteria: inclusion criteria:

 Soft tissue abscess suspected by patient history and physical exam and confirmed by bedside ultrasound

 Able to provide written consent/ assent

 Incision and drainage to be performed by ED physician

Exclusion criteria: :

 Peritonsillar abscess

 Pilonidal cyst, genital or perirectal abscess

 Post-surgical wound infections

 Pregnant

 Prisoners

 Previous incision and drainage for current abscess

['Ultrasound Guided Incision and Drainage', 'Blind Incision and Drainage']

Ultrasound Guided Incision and Drainage
Blind Incision and Drainage


EXTEND EXpanding Treatment for Existing Neurological Disease

Summary: The primary goal of the Phase II EXTEND trial is to investigate the effects of open-label hydroxyurea treatment, escalated to maximum tolerated dose, for children with Sickle Cell Anemia and either conditional (170 - 199 cm/sec) or abnormal (≥200 cm/sec) Transcranial Doppler velocities. The primary endpoint will be measured after 18 months of hydroxyurea but treatment will continue until a common study termination date.
Inclusion criteria: inclusion criteria:

 Pediatric participants with a severe form of sickle cell anemia (HbSS, HbSβ0 thalassemia, HbSD, HbSOArab)

 Age: ≥ 2 and ≤ 17 years of age, at the time of enrollment

 Time-averaged maximum velocity (TAMV) TCD Velocity in the conditional (170 - 199 cm/sec) or abnormal (≥200 cm/sec) range by Transcranial Doppler ultrasonography examination within 6 months of enrollment, abnormal or conditional TCD velocity and currently on commercial hydroxyurea for primary stroke prevention, or previously enrolled in SCATE, a previous stroke with abnormal or conditional TCD prior to stroke event.

 Parent or guardian willing and able to provide informed consent and child gives assent

 Ability to comply with study related treatments, evaluations, and follow- up visits

Exclusion criteria: :

 Inability to take or tolerate daily oral hydroxyurea, including

 Known allergy to hydroxyurea therapy

 Known positive serology to HIV infection

 Known malignancy

 Current lactation

 Abnormal historical laboratory values (most recent pre-enrollment values unless previously enrolled in SCATE):

 Hemoglobin concentration < 6.0 gm/dL

 Absolute reticulocyte count < 100 x 109/L with a hemoglobin concentration < 8.0 gm/dL

 White Blood Cell (WBC) count < 3.0 x 109/L

 Absolute neutrophil count (ANC) < 1.0 x 109/L

 Platelet count < 100 x 109/L

 Use of therapeutic agents for sickle cell disease (e.g., hydroxyurea, arginine, decitabine, magnesium, chronic transfusions) within 3 months of enrollment unless they have an abnormal TCD velocity and receive commercial hydroxyurea for primary stroke prevention or were previously enrolled in the SCATE study or for secondary stroke prevention in a child with a previous stroke.

 Current participation in other therapeutic clinical trials, except SCATE

 Known serum creatinine more than twice the upper limit for age AND

 1.0 mg/dL

 Any condition or chronic illness, which in the opinion of the clinical investigator makes participation ill-advised

 Pregnancy (for post-menarchal females only)

 Erythrocyte transfusion within the past 2 months

 Previous stem cell transplant or other myelosuppressive therapy (unless they have an abnormal TCD velocity and receive commercial hydroxyurea for primary stroke prevention or for secondary stroke prevention in a child with a previous stroke or were previously enrolled in SCATE)


Viral Inception of Asthma: Prospective Study From Infancy to School-age

Summary: The purpose of this study is to study prospectively the early clinical and immunological events in children susceptible to rhinovirus induced early wheezing (i.e., recently found highest risk factor for recurrent wheezing/asthma) and the efficacy of systemic corticosteroid to modify these events.~Up to 50% of children suffer from acute wheezing before school-age. The prevalence of childhood asthma is 5-7%. Although pediatric asthma is mainly allergic, the exacerbations are associated with respiratory viral infections in 95% of cases. The means to predict asthma from environmental factors have been limited mainly to sensitization to aeroallergens (3-fold risk), which start to develop usually at 2-3 years of age. VINKU 1-study (orig. VINKU-study) discovered simultaneously with two other groups, that early wheezing associated with rhinovirus, the common cold virus, is the strongest predictor of recurrent wheezing/asthma (up to 10-fold risky). Noteworthily, viral infections work as risk markers already during infancy, a lot earlier than the sensitization to aeroallergens. The investigators also found retrospectively that early wheezers affected by rhinovirus responded to 3 day course of oral prednisolone (inexpensive and widely available treatment): recurrent wheezing decreased by 50% during following 12 months and the difference appeared to continue. VINKU 5V-study is currently investigating the clinical history, prevalence of asthma and airway hyperreactivity of these same children at school-age. The mechanism of rhinovirus associated risk or why they respond to prednisolone are largely unknown. However, the susceptibility to rhinovirus infections is associated with atopy and therefore it is possible these children may have impaired anti-inflammatory (Treg) responses and more likely to wheeze with any pro-inflammatory response (Th1 or Th2). Moreover, they may not effectively clear viruses, because they can not limit rhinovirus to nose and it spreads to lower airways and causes wheezing. VINKU 2-study will prospectively investigate the immunological events in young first-time wheezers affected by rhinovirus, and prospectively study the clinical efficacy of systemic corticosteroid in them. Most likely these children will benefit from the drug in terms of less recurrent wheezing, the investigators will also explore immunological effects of the drug and their link to clinical efficacy. The results are expected to give basis for the prevention of asthma and for the development of new treatment strategies and they can be directly applied to clinical medicine.
Inclusion criteria: inclusion criteria:

 age 3-23 months

 be delivered at >=37 weeks

 first wheezing episode

 written informed consent from guardian

Exclusion criteria: :

 chronic illness other than atopy

 previous systemic or inhaled corticosteroid treatment

 participation to another study

 varicella contact if previously intact

 need for intensive care unit treatment, or

 poor understanding of Finnish


Trial of Iseganan in Prevention of Ventilator-Associated Pneumonia

Summary: This is a multinational, double-blind, placebo-controlled trial designed to assess whether iseganan, applied topically to the oral cavity, can prevent ventilator-associated pneumonia among patients who are intubated and mechanically ventilated and survive for up to 14 days.
Inclusion criteria: inclusion criteria:

 Greater than or equal to 18 years of age

 Orally/nasally intubated and receiving mechanical ventilation for <24 hours prior to scheduled randomization and administration of the first dose of Study Drug, and in the judgment of the attending physician, expected to remain intubated and mechanically ventilated for at least 48 hours

 Expected to survive for at least 21 days and to remain at the investigational site and not transferred to another institution while intubated during the 21-day study period

 Willing and able to provide written informed consent, or if unconscious or have altered sensorium, have a surrogate provide written informed consent as approved by the institution

 Negative pregnancy test within 7 days prior to randomization if a female of childbearing potential (Negative pregnancy test results [urine or serum] obtained for reason other than the purposes of this study are acceptable.)

Exclusion criteria: :

 Current diagnosis of pneumonia (Patients currently receiving antibiotics for treatment of pneumonia and patients who meet the study definition of clinically defined pneumonia at the time of screening will be excluded.)

 Absolute neutrophil count less than 1000/mm3

 Human immunodeficiency virus infection with a last known CD4 count less than 500/mm3

 Recipient of organ transplantation and receiving immunosuppressive therapy

 Current hematologic malignancy

 Previously documented cystic fibrosis

 Severe cranio-facial trauma or other medical condition expected to require imminent tracheostomy

 Patient, patient's family and/or physician not in favor of aggressive medical management or presence of an advanced directive to withhold life-sustaining treatment

 Moribund state or expected to survive less than 21 days due to an uncorrectable medical condition

 Participation in a clinical trial of any unlicensed drug, biologic or device within 30 days prior to the first dose of study drug

 Concurrent participation in a clinical trial of any unlicensed drug, biologic or device.


Comparative Study of Prophylactic Agent for Venous Thromboembolism After Total Knee Arthroplasty

Summary: The purpose of this study is to compare the efficacy of two prophylactic agent(aspirin 300mg/day and rivaroxaban 10mg/day) for venous thromboembolism after total knee arthroplasty.
Inclusion criteria: inclusion criteria:

 all patients undergone primary total knee arthroplasty

Exclusion criteria: :

 renal insufficiency, contrast allergy, simultaneous bilateral TKA, hemorrhagic disorder, sever liver disease


Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)

Summary: The SHEP Pilot Study had six objectives, each designed to develop and test critical components of a full scale trial directed at the health consequences of treating isolated systolic hypertension (ISH) in the elderly.~l. To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques.~2. To estimate compliance with the visit schedule and to the prescribed double-blind regimens.~3. To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure.~4. To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population.~5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population.~6. To develop and test methods of ascertaining stroke and other disease endpoints.
Inclusion criteria: Men and women, aged 60 or over. Isolated systolic hypertension. Normal diastolic pressure of less than 90 mm Hg.
Exclusion criteria:

['chlorthalidone', 'reserpine', 'hydralazine', 'metoprolol']

chlorthalidone reserpine hydralazine metoprolol

['Cardiovascular Diseases', 'Heart Diseases', 'Hypertension', 'Vascular Diseases']

Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases


A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

Summary: Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.
Inclusion criteria: inclusion criteria:

 Healthy infant/child aged 5-17 months at the time of first study vaccination

 Informed consent of parent/guardian

 Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up

Exclusion criteria: :

 Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.

 Weight-for-age Z score of less than -3 or other clinical signs of malnutrition

 History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation

 History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone.

 Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator

 Serum Creatinine concentration greater than 70 µmol/L, where judged to be clinically significant in the opinion of the investigator

 Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator

 Blood transfusion within one month of enrolment

 Previous vaccination with experimental malaria vaccines.

 Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine.

 Current participation in another clinical trial, or within 12 weeks of this study.

 Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data

 Known maternal HIV infection (No testing will be done by the study team)

 Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)

['ChAd63 ME-TRAP and MVA ME-TRAP', 'Rabies vaccine']

ChAd63 ME-TRAP and MVA ME-TRAP
Rabies vaccine


PCI and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes

Summary: Research hypothesis:~Is the treatment with renal denervation (RDN) early post ACS safe and effective and does it leads to improved cardiac function and attenuation of pathologic left ventricular remodelling? In a following study, the hypothesis will be tested in a larger ACS population with major adverse cardiovascular events (MACE) after ACS as the endpoint.~Rationale for conducting this study:~ACS i.e. ST-elevation myocardial infarction (STEMI) and non- ST-elevation myocardial infarction (non-STEMI) are the most important causes of morbidity and mortality in western societies. Hypertension is a major risk factor for development of ACS and heart failure but it also worsens the prognosis in patients after ACS. Our research highlights the combination therapy of PCI and RDN in an ACS patient population with simultaneous hypertension.~Primary objective:~The primary objective of this study is to establish safety and efficacy of combined treatment with PCI and renal denervation (RDN) in hypertensive patients with acute coronary syndromes (STEMI and non-STEMI ) having ventricular mass after 4 months as the primary variable.~Endpoints:~The primary end point is change in left ventricular mass (LVM) at 4 months evaluated by magnetic resonance imaging (MRI).~Secondary endpoints:, blood pressure (office and 24-h ABPM), and left ventricular volumes and ejection fraction.
Inclusion criteria: inclusion criteria:

 Provision of informed consent prior to any study specific procedures

 Female and/or male aged 18-80 years

 Patients with ACS, i.e. STEMI, non-STEMI, treated with PCI

 Medical history of treated (ongoing) hypertension, or hypertension discovered at the time of ACS, and office SBP >140 despite treatment with three antihypertensive drugs.

 Ejection fraction >40%.

Exclusion criteria: :

 Increased risk of pathological bleedings

 Office systolic blood pressure <120

 Renal artery abnormalities.

 eGFR <30 mL/min

 ICD or pacemaker, or any other metallic implant not compatible with MRI

 Estimated survival time <1 year

 Not oriented to person, place and time

 Inability to understand given information about the study

 Fertile female

['Hypertension', 'Acute Myocardial Infarction']

Hypertension
Acute Myocardial Infarction


Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges

Summary: Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray.
Inclusion criteria: inclusion criteria:

 Healthy men and women

 Ages 18 or older -

Exclusion criteria: :

 Under 18 years of age

 Pregnant female or if female has not had a negative pregnancy test prior to the research scans.

 -

['Abdominal radiographs with microfabricated tags']

['Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation']


Care Management for Patients With Alzheimer Disease and Their Family Caregivers

Summary: This is a clinical trial to test the effectiveness of current guideline for the care of older adults with Alzheimer's disease. The study focuses on the primary care setting using a nurse care manager to facilitate guideline-level care. We are hypothesizing that patients who receive guideline-level care will have fewer behavioral problems than those who receive the usual care provided in primary care settings
Inclusion criteria: inclusion criteria:

 Alzheimers Disease

Exclusion criteria: :

 Inability to understand English

 No telephone

inclusion criteria:

 Alzheimers Disease


Alterations of the Uteroplacental and Fetal Pulmonary Circulation Following Amnioinfusion

Summary: The aim of this study is to compare the uteroplacental and pulmonary circulation of the fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in normal controls. Further purpose of the study is to measure the changes of the uteroplacental and fetal pulmonary circulation in patients presenting with severe idiopathic oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.
Inclusion criteria: inclusion criteria:

 Patients above 18 years, who are able to consent;

 Singleton pregnancy;

 Normal structural examination between 16 and 20 weeks of gestation;

 Gestation between 18 and 34 weeks (the pregnancy duration determined by ultrasound verification within the 20th week);

 At least two US examinations at the presentation for confirmation and for the diagnosis of persistent oligohydramnios;

 Follow up ultrasound examinations weekly in both groups.

Exclusion criteria: :

 1. pPROM; 2. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes; 3. Symptoms referring incomplete abortion before 24 weeks of gestation; 4. Maternal contraindications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make the intervention riskful; 5. No active premature labor (shortened cervix <15 mm, <3 cm of cervical dilatation; >6/hour uterine contractions) after 24 weeks of gestation; 6. Cervical cerclage in place; 7. Clear signs of maternal or fetal infection (2 or more of the following: maternal tachycardia >100/min, maternal temperature >38°C, maternal white blood count cells (WBC) >15,000/ml, maternal C-reactive protein (CRP) >20 mg/l, uterine tenderness, foul-smelling vaginal discharge, fetal tachycardia >160 bpm); 8. Suspicion of placental abruption (uterine tenderness and bleeding episodes); 9. Previous invasive procedure in the pregnancy; 10. Fetal condition mandating immediate delivery; 11. Severe bleeding at present; 12. Maternal HIV and HBV/HCV infection; 13. Multiple gestation.

 -


INfusion VErsus STimulation in Parkinson's Disease

Summary: Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). To date, no comparative studies have been executed. The INVEST study is an open label randomised controlled trial with cost-effectiveness as primary outcome. The main clinical outcome is quality of life; secondary outcomes are motor symptoms and neurological impairments, among others.
Inclusion criteria: inclusion criteria:

 Idiopathic Parkinson's Disease with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry;

 Despite optimal pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonia or bradykinesia;

 A life expectancy of at least two years.

Exclusion criteria: :

 Age below 18 years

 Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);

 Previous CLI (through a PEG-tube or Nasal Jejuna| tube);

 Hoehn and Yahr stage 5 at the best moment during the day;

 Other severely disabling disease;

 Dementia or signs of severe cognitive impairment

 Psychosis;

 Current depression;

 Contraindications for DBS surgery, such as a physical disorder making surgery hazardous;

 Contraindications for PEG surgery such as interposed organs, ascites and oesophagogastric varices, or for Duodopa;

 Pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception;

 No informed consent;

 Legally incompetent adults;

['Continuous intrajejunal infusion of levodopa-carbidopa', 'deep brain stimulation']


Skin Ulcers Treatment With an Handicraft Topical Device

Summary: The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.
Inclusion criteria: inclusion criteria:

 Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo.

 Patients of both sexes.

 Patients over 18 years.

 Patients that have basic laboratory at admission (complete blood count with differential).

 Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.

Exclusion criteria: :

 Hemodynamically unstable patients.

 Patients with septic shock from any source.

 Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure.

 Patients with secondary cutaneous ulcer enteral fistula.

 Patients with cutaneous ulcer or cancer tumors.

 Patients with cutaneous ulcer with active bleeding.

 Patients with cutaneous ulcer necrosis.

 Patients with cutaneous ulcer leishmania, insect bite.

 Patients with cutaneous ulcer burns.

 Patients who do not accept their participation in the study through informed consent.


Combined Subthalamic and Nucleus Basalis Meynert Deep Brain Stimulation for Parkinson's Disease With Dementia

Summary: Phase 1 study evaluating the safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having mild to moderate dementia.
Inclusion criteria: inclusion criteria:

 Age at the time of enrollment: 35 - 75 years.

 Diagnosis of idiopathic PD with probable Parkinson's disease dementia (PDD) as defined by the MDS consensus guidelines (Emre et al., 2007)

 Mild to moderately severe dementia as defined by a Mini-Mental State Examination (MMSE) score of 10 to 24

 Duration of bilateral idiopathic PD: ≥5 years of motor symptoms.

 Severity of bilateral idiopathic PD in the meds off state: modified Hoehn and Yahr stage ≥2.

 UPDRS subset III score of ≥30 in the meds off, stim off state.

 Levodopa must improve PD symptoms by ≥30% in a levodopa challenge test, as measured by UPDRS subset III score.

 PDD with a symptom onset at least 2 years after first symptoms of PD

 Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary) if mentally competent or, if incompetent, their legally authorized representatives.

 Able to understand the study requirements and the treatment procedures and to provide written informed consent before any study-specific tests or procedures are performed. If mentally incompetent, the legally authorized representative provides written informed consent

Exclusion criteria: :

 Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.

 Any current drug or alcohol abuse.

 Any history of recurrent or unprovoked seizures.

 Any prior movement disorder treatments that involved intracranial surgery or device implantation.

 A history of neurostimulation intolerance in any area of the body.

 Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.

 Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.

 Pregnancy, breast-feeding, or lack of reliable contraception

['Vercise deep brain stimulation', 'subthalamic nucleus (STN) stimulation', 'NBM stimulation', 'sham stimulation']

Vercise deep brain stimulation
subthalamic nucleus (STN) stimulation
NBM stimulation
sham stimulation


Cognitive Impairment and Balance in Elderly

Summary: One important issue in older adults with cognitive problems is the higher risk of fall due to decreased motor function and balance. The objective of this study is to evaluate the repercussions of mild cognitive impairment in balance in elderly.
Inclusion criteria: inclusion criteria:

 Nursing home residents.

Exclusion criteria: :

 Surgery on lower limbs.

 Traumatic damage on lower limbs.

 Severe cognitive impairment in order not to complete the assessment.


Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy

Summary: MAIN OBJECTIVE :~To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual development of the child from 6 to 9 years~SECONDARY OBJECTIVES :~To assess the consequences of a maternal hyperthyroïd during pregnancy on the capacities of attention, learning process and the degree of hyperactivity of the child from 6 to 9 years.~To study if it exist differences of intellectual development, capacities of attention, learning process, and degree of hyperactivity in the child from 6 to 9 years, born to hyperthyroid mother during pregnancy, according to:~the etiology of the maternal hyperthyroïd (transitory gestation hyperthyroid versus disease of Basedow),~the use or not of a anti-thyroid treatment,~the rate of TSH néonatal (measured with the blotter by tracking with J3 at all the new born ones).
Inclusion criteria: inclusion criteria:

 A-For the child born to hyperthyroid mother during pregnancy :

 oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age

 B-For hyperthyroid mother during pregnancy :

 oHyperthyroïd during pregnancy (transitory gestation hyperthyroid or disease of Basedow) oEuthyroïd at the time of the entry in the study

 C-For the child born to euthyroid mother during pregnancy :

 oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age

 D-For euthyroid mother during pregnancy :

 Euthyroïd at the time of the entry in the study

Exclusion criteria: :

 A-For the child born to hyperthyroid mother during pregnancy :

 Discovered of a thyroid dysfonction at the time of the entry in the study

 B-For hyperthyroid mother during pregnancy:

 Discovered of a thyroid dysfonction at the time of the entry in the study

 C-For the child born to euthyroid mother during pregnancy:

 Discovered of a thyroid dysfonction at the time of the entry in the study

 D-For euthyroid mother during pregnancy:

 oDiscovered of a thyroid dysfonction at the time of the entry in the study oCarrying anti-TPO antibody at the time of the entry in the study

['Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.']


Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients

Summary: Polymyalgia rheumatica (PMR) is a common inflammatory condition affecting elderly people and involving the girdles. The mainstay of treatment is oral glucocorticoids (GC), with the recent BSR-BHPR guidelines suggesting an initial prednisone dose comprised between 15 and 20 mg as appropriate. However, probably because of the dramatic response of PMR to GC, randomized controlled trials of treatment are lacking. As a result, there is no evidence from controlled studies on the efficacy of different initial doses or drug tapering. Objective of the study: to test if 12.5 mg prednisone/day is an adequate starting dose in polymyalgia rheumatica (PMR) and to evaluate clinical predictors of drug response.~Methods: 60 consecutive PMR patients will be treated with a starting dose of 12,5 mg/day prednisone. Clinical, laboratory, and ultrasonographic features will be recorded as possible predictors of response to prednisone. Remission is defined as disappearance of at least 75% of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, a scenario allowing steroid tapering.
Inclusion criteria: inclusion criteria:

 patients with PMR, diagnosed according to the criteria of Bird et al

Exclusion criteria: :

 patients with arthritis

 patients with giant cell arteritis

 patients with Parkinson's disease

 patients with hypothyroidism

 patients with scapulohumeral periarthritis

 patients with fibromyalgia

 patients unable to cooperate


Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes

Summary: Excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access.~The study hypothesis is that the use of radial access device dedicated radioprotective TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization.
Inclusion criteria: inclusion criteria:

 Unstable angina with an indication for invasive stratification

 Acute coronary syndrome without ST-segment elevation

 Acute coronary syndrome with ST-segment elevation

 Patient informed of the nature of the study and have signed the Informed Consent

 Patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral

Exclusion criteria: :

 Below 18 years of age

 Pregnancy

 Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of factor Xa,

 Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance <30 mL / min, platelet count <100,000 mm3);

 Uncontrolled hypertension;

 Cardiogenic shock;

 Previous coronary artery bypass graft surgery with the use of ≥ 1 graft

 Patients not candidates for the use of any of the specified vascular access

 Concomitant severe disease with life expectancy less than 12 months life;

 Medical, geographical, or social conditions that impede study participation

 Refusal or inability to understand and sign the informed consent form.

['Acute Coronary Syndromes', 'Angioplasty, Transluminal, Percutaneous Coronary']

Acute Coronary Syndromes
Angioplasty
Transluminal
Percutaneous Coronary


The Protection Effect of Speeda® Rabies Vaccine for Human Use

Summary: The objective of this study was to achieve the post-marketing protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.
Inclusion criteria: inclusion criteria:

 Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed

 Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months before injured

 The man-killer could found and detect whether it carries the virus

Exclusion criteria: :

 Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth

 Apply passive immunity preparation


Sub-Study of the PREVIEW Study Australia

Summary: The aim of this study is to investigate possible enduring effects of a standard 2-month weight loss program on appetite regulation, bone homeostasis and muscle strength in younger and older adults, as well as the impact of differences in dietary composition during weight maintenance.
Inclusion criteria: inclusion criteria:

 Age 25 - 45 years and 55 - 70 years

 Overweight or obesity status BMI>25 kg/m2

 Pre-diabetes. The criteria from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal inclusion criteria, i.e. having: Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 - 6.9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 - 11.0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l. Due to potential between-lab variation (local assessments), HbA1c is not used as an inclusion criteria in the screening.

 Informed consent required

 Ethnic group - No restrictions

 Smoking - Smoking is allowed, provided subjects have not recently (within 1 month) changed habits. However, smoking status is monitored throughout the study and used as a confounding variable.

 Motivation - Motivation and willingness to be randomized to any of the groups and to do his/hers best to follow the given protocol

 Other - Able to participate at CID's during normal working hours.

Exclusion criteria: :

 Based on interview and/or questionnaire, individuals with the following problems will be excluded:

 Medical conditions as known by the subjects: Diabetes mellitus (other than gestational diabetes mellitus); Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease; Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months; Advanced chronic renal impairment; Significant liver disease e.g. cirrhosis (fatty liver disease allowed); Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed); Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption; Previous bariatric surgery; Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program); A recent surgical procedure until after full convalescence (investigators judgement); Transmissible blood-borne diseases e.g. hepatitis B, HIV; Psychiatric illness (e.g. major depression, bipolar disorder).

 Medication: Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.

 Personal/Other: Engagement in competitive sports; Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening; Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed; Severe food intolerance expected to interfere with the study; Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women); Use of drugs of abuse within the previous 12 months; Blood donation or transfusion within the past 1 month before baseline or CID's; Self-reported eating disorders; Pregnancy or lactation, including plans to become pregnant within the next 36 months; No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase); Adequate understanding of national language; Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol.

 Laboratory screening: If all of the above criteria are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation.

 ONLY IF the glucose tolerance test meets the entry criteria for the study, the remaining samples are sent to the local laboratory for a safety check, with the following

['Low calorie diet administered from 0 to 2 months', 'High Protein / Low Glycaemic Index', 'Moderate Protein / High Glycaemic Index']


Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome

Summary: The aim of this study is to determine the efficacy of FITNET (web-based cognitive behavioural treatment) for adolescents with Chronic Fatigue Syndrome (CFS) in The Netherlands. The second goal of the study is to establish predictors of outcome. It is very important to know the characteristics of patients who will benefit from Cognitive Behavioural Treatment (CBT) and who will not. Possible predictors of outcome are: age, depression, anxiety, fatigue of the mother, parental bonding, self-efficacy, body consciousness of child and mother, physical activity (Actometer).
Inclusion criteria: inclusion criteria:

 Adolescents (12 - 18 years) with Chronic Fatigue Syndrome

Exclusion criteria: :

 Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children

 Score greater than or equal to 20 on the Children's Depression Inventory

 No availability of computer and/or internet

 Risk of suicide

 Mental retardation


Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab

Summary: The purpose of this study is to determine if an anti-inflammatory drug, called infliximab, will reduce inflammation in the synovial lining in patients with an early stage of osteoarthritis of the knee. It will also help determine if the study medication decreases the accumulation of synovial fluid and prevents cartilage breakdown.
Inclusion criteria: inclusion criteria:

 Adults ≥ age 35 but ≤ age 85.

 Painful knees for 3-60 months.

 VAS joint pain score greater than 30 mm (scale 0-100)

 Knee radiograph showing minimal to moderate change (early OA).

 No NSAID therapy for at least one week.

 Have the capacity to understand and sign an informed consent form.

 Gender: Male or female

 Women must be postmenopausal (no menstrual period for a minimum of 1 year) or surgically sterilized and have a negative serum pregnancy test on entry in the study. Men must agree to use adequate birth control during the study for 6 months after the infusion of study agent.

 Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.

 The screening laboratory test results must meet the following criteria

 WBC (white blood cell count): >3.5/uL

 Hemoglobin: > 10 gm/dl

 Platelets: > 100,000/ul

 Serum Creatinine: < 1.8

 SGPT (ALT - alanine aminotransferase) <3 times ULN

 UA (urinalysis) with microscopic exam: WNL

 Negative tests for HbsAg or hepatitis C Ab

 PT/PTT: WNL

 Are considered eligible according to the following TB screening criteria:

 Have no history of latent or active TB prior to screening. An exception is made for subjects who have a history of latent TB (defined for the purposes of this study as having had a positive result from either the tuberculin skin test or the QuantiFERON-TB Gold test prior to screening) and documentation of having completed an adequate treatment regimen for latent TB within 3 years prior to the first administration of study agent under this protocol. Adequate treatment for latent TB is defined according to local country guidelines for immunocompromised patients. If no local guidelines for immunocompromised patients exist, US guidelines must be followed. It is the responsibility of the investigator to verify the adequacy of previous anti-TB treatment and provide appropriate documentation.

 Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.

 Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.

 Within 1 month prior to the first administration of study agent, either have negative diagnostic TB test results (defined as both a negative tuberculin skin test and a negative QuantiFERON-TB Gold test, as outlined in Attachment 3 and Attachment 4, respectively), or have a newly identified positive diagnostic TB test result (defined as either a positive tuberculin skin test or a positive QuantiFERON-TB Gold test) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. The tuberculin skin test and QuantiFERON-TB Gold test are not required at screening for subjects with a history of latent TB and documentation of having completed adequate treatment as described in Inclusion Criterion 12a. Furthermore, these subjects are not required to initiate additional treatment for latent TB.

 Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.

Exclusion criteria: :

 Moderate to Severe OA, as determined by severe joint space narrowing (Kellgren grade IV) (7) in medial and lateral compartments

 Insulin-dependent diabetes mellitus.

 Systemic inflammatory illness, e.g. rheumatoid arthritis.

 Intra-articular injections within 3 months.

 Prior treatment with infliximab or other anti-TNF drug.

 Acute injury to knees (< 2 weeks)

 Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion).

 Have had any previous treatment with monoclonal antibodies or antibody fragments.

 History of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an exclusion criterion

 Documentation of a positive test for hepatitis B surface antigen or hepatitis C.

 Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results.

 Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.

 Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening

 Currently receiving Coumadin, Ticlid, Plavix, or heparin/heparin analog within 7 days prior to synovial biopsy.

 Currently receiving aspirin within 7 days prior to synovial biopsy.

 Have a chest radiograph at screening that shows evidence of malignancy or infection.

 Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.

 Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence as well as carcinoma in situ of the cervix.

 Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.

 Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.

 Use of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer.

 Presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening).

 Have a concomitant diagnosis or history of congestive heart failure Grade III-IV.

 Have had a nontuberculous mycobacterial infection or opportunistic infection (e.g., cytomegalovirus, Pneumocystis carinii, and aspergillosis) within 6 months prior to screening.

['Infliximab', 'Placebo', 'Standard of Care: Methylprednisolone acetate']


Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients

Summary: To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
Inclusion criteria: inclusion criteria:

 age over 18 years;

 type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years;

 presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner's classification ) and existing for at least three months;

 giving their written informed consent.

Exclusion criteria: :

 hypersensibility to heparin or pig derivatives

 body weight lower than 35 kg

 presence of clinical signs of infection that did not resolve in spite of oral antibiotics;

 anticoagulant therapy;

 severe impairment of renal or hepatic function;

 bleeding disorder;

 active peptic ulcer;

 arterial hypertension with poor control;

 pregnancy or lactation;

 terminal illness or a prognosis of survival under three months.

['bemiparin (low molecular weight heparin)']

['Foot Ulcer, Diabetic', 'Diabetic Angiopathies']

Foot Ulcer
Diabetic
Diabetic Angiopathies


DYsphAgia In Mechanically Ventilated ICU patientS

Summary: Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. In the present observational analysis, the investigators aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of ICU patients post invasive mechanical ventilation.
Inclusion criteria: inclusion criteria: all adult ICU patients post mechanical ventilation (observational analysis)

Exclusion criteria: :

 patients prone to die / moribund patients/ or dying patients

 patients post oesophageal resection / with oesophageal rupture


The Effects of Surgery for Painful External Snapping Hip

Summary: The purpose of this study is to assess the pain-relieving effects of surgery for painful external snapping hip.
Inclusion criteria: inclusion criteria:

 Patients undergoing surgery for painful external snapping hip

 18 years or older

Exclusion criteria: :

 Inability to comply with the protocol (e.g. due to dementia)


Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis

Summary: This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography.
Inclusion criteria: inclusion criteria:

 Digital gangrene, ulcers in patients with severe secondary Raynaud's phenomenon

 Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil.

 Unchanged immunosuppressive therapy 3 months before treatment with sildenafil

 No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy

Exclusion criteria: :

 Therapy with iloprost during the last 4 weeks

 Sympathectomy during the last 4 weeks

 TIA, stroke, myocardial infarction during the last 6 months

 Instable angina pectoris

 Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia

 Microangiopathic hemolytic anaemia

 Azotaemia

 Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers)

 Left ventricular ejection fraction< 20%

 Hypotonus < 80/40 mm Hg

 Positive pregnancy test

 History of cancer

 History of gastric/duodenic ulcers without endoscopic proof of complete healing

 Participation in other studies (currently or during the last 4 weeks)

 Abuse of alcohol or other drugs, smoker

 Cardiac failure, use of nitrates


Treatment of West Nile Virus With MGAWN1

Summary: This study will test a drug called MGAWN1 for the treatment of West Nile infections.
Inclusion criteria: inclusion criteria:

 Provide written informed consent

 Be >=18 years of age at the time of enrollment

 Have West Nile Fever defined as:

 temperature >38°C, headache, AND

 positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum or cerebrospinal fluid (CSF)

 OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as:

 • West Nile encephalitis (must meet criteria a and b below)

 Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours)

 CSF pleocytosis >=5 cells/mm^3

 AND/OR

 • West Nile meningitis (must meet criteria c and d)

 Clinical signs of meningeal inflammation, including nuchal rigidity, Kernig or Brudzinski sign, photophobia, or phonophobia

 CSF pleocytosis >=5 cells/mm^3

 AND/OR

 • Acute flaccid paralysis (must meet criteria e and f)

 Acute onset of limb weakness with marked progression over 48 hours

 Two or more of the following conditions:

 asymmetry to weakness

 areflexia or hyporeflexia of affected limb(s)

 absence of pain, paresthesia, or numbness in affected limb(s)

 CSF pleocytosis >=5 cells/mm^3

 CSF elevated protein levels (4.5 g/L)

 electrodiagnostic studies consistent with an anterior horn cell process

 or abnormal increased signal in the anterior gray matter as documented by spinal cord magnetic resonance imaging

 Have epidemiological factors consistent with West Nile Virus infection (must meet criterion a or b below):

 Appropriate time of year for West Nile Virus transmission in region

 Travel history to a region where West Nile Virus is active

 Develop signs and/or symptoms within 14 days before study enrollment.

 If female of childbearing potential or male and in a sexual relationship with a female of childbearing potential, agree (or have partner agree) to practice abstinence or use 2 of the following methods of contraception for 120 days (approximately 4 months) after study drug administration:

 Oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches

 An intrauterine device

 Barrier contraception (condom) with a spermicide (i.e., female subject ensures use by male partner[s])

 Any other equivalent method of contraception (as judged by the investigator)
Exclusion criteria:

['West Nile Neuroinvasive Disease', 'West Nile Virus Infection', 'Encephalitis', 'Meningitis', 'Acute Flaccid Paralysis', 'West Nile Fever']

West Nile Neuroinvasive Disease
West Nile Virus Infection
Encephalitis
Meningitis
Acute Flaccid Paralysis
West Nile Fever


Prophylaxis Against Malaria to Enhance Child Development (PROTECT Study)

Summary: Each year, ~85.3 million pregnant women are at risk of becoming infected with Plasmodium falciparum(1). Among women in sub-Saharan Africa, most of whom have some degree of clinical immunity to malaria, malaria infection in pregnancy leads to placental malaria (PM), often without clinical symptoms in the mother. The systemic and placental changes that occur with malaria in pregnancy can adversely affect the developing fetal brain, an fetal brain injury strongly affects long-term childhood neurodevelopmental (ND) and behavior but there are no published studies to date on the impact of malaria in pregnancy on childhood ND. This study, conducted in Uganda, will address the effects of malaria in pregnancy and childhood ND and define mechanisms by which malaria may lead to ND impairment including micronutrient deficiencies. ND outcomes will be measured by the following neuropsychological and behavioral tests: Mullen Scales of Early Learning, the Color Object Association Test, the Early Childhood Vigilance Test, the Behavior Rating Scales, the Behavior Related inventory of Executive Function and the Child Behavior Checklist. These tests will be given at 12, 24, 36, and 60 months of age. This study will be nested in an ongoing Ugandan IRB approved interventional trial (PROMOTE-II) (NCT02163447). Blood sampling is being conducted in the PROMOTE-II protocol for research purposes. Some of that blood will be used to test for micronutrient deficiencies as well as other immune responses to malaria.
Inclusion criteria: inclusion criteria:

 Enrolled in Makerere University-UCSF PROMOTE II study

 HIV-uninfected

 12 months of age at the time of enrollment

 Within 30 km of the clinic

Exclusion criteria: :

 Serious adverse event to the study drugs requiring cessation of study drug

 Active illness at enrollment (child can be enrolled once active illness has been treated and they are back to baseline health)

 Previous history of head trauma or coma in the child

 Cerebral palsy or other severe neurologic disease

 Known chronic illness requiring medical care

 Major medical abnormalities on screening history of past health

 Known developmental delay


Falls Prevention in Osteoporosis

Summary: The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.
Inclusion criteria: inclusion criteria:

 osteoporosis (DXA T-score < -2.5 in hip and/or vertebrae)

 able to walk at least 15 minutes without an helping device

 65 years or older

 community dwelling

 at least one fall in the prior year

Exclusion criteria: :

 severe cardiac, pulmonary or musculoskeletal disorders

 pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease)

 use of psychotropic drugs


Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting

Summary: Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.
Inclusion criteria: inclusion criteria:

 Male and female patients between the ages of 18-65 years, inclusive

 Patients (or legal representative) willing and able to provide written Informed Consent Form.

 Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders- IV, Diagnostic and Statistical Manual of Mental Disorders- V or International Code of Disease criteria.

 Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting.

 Previously treated with ADASUVE® with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)

 Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema).

 Requirement of family or other caregiver support at study investigator criteria (defined as a patient's relative or caregiver (male or female) ≤ 80 year old, who spend ≥ 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures).

 Availability of patient's medical records data about the previous treatment with ADASUVE® at hospital setting.

 If a female is of childbearing potential and sexually active (except if female is surgically sterile or post-menopausal with history of no menses for at least 24 months), patient must be non-lactating and non-pregnant (with a negative pregnancy test result at baseline visit) and have to agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.

Exclusion criteria: :

 Patient diagnosed with dementia.

 Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis).

 Patients with a history of allergic reactions to loxapine or amoxapine

 Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.

 Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device.

['Staccato® Delivery System Loxapine (ADASUVE®)']


Non Cardiac Chest Pain and Benign Palpitations

Summary: All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have symptoms of chest pain or palpitation. If they still have some of the symptoms they are invited to participate in a coping course to learn a better way to deal with their symptoms.~The coping course consist of three sessions of cognitive behaviour therapy.
Inclusion criteria: inclusion criteria:

 investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital

 suffer of chest pain or palpitations

Exclusion criteria: :

 do not speak norwegian properly

 mentally retarded

 psychosis last 6 month

 current alcohol or drug misuse

['Anxiety/Depression in Cardiological Unit']


Computed Tomography CT Venography During Postpartum Venous Thromboembolism

Summary: The purpose of this study is to determine whether systematically performing computed tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during the venous phase of opacification) in addition to thoracic CT angiography in women with suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism detection rate.
Inclusion criteria: inclusion criteria:

 Women with clinically suspected pulmonary embolism (PE) during the first 6 weeks postpartum, without any sign of severe PE (shock, hypotension), referred for CT angiography

 Absence of contraindication to iodinated contrast medium injection (Previous allergic reaction to iodinated contrast medium, renal insufficiency with creatine clearance less than 30mL/mn, uncontrolled hyperthyroidism)

 Age > 18 years

 Health insurance

 Possibility to have 3-month follow-up

 Obtention of written informed consent (ability to give consent)

Exclusion criteria: :

 Anticoagulation at therapeutic dosage for another reason than the suspicion of PE for more than 72 hours

 New pregnancy (In case of any doubt after medical history review, βHCG blood test must be realized to ensure patient's pregnancy status)

 Contrast medium extravasation during injection

 CTA or CTV not performed according to the study requirements


Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)

Summary: The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective treatment for Traveler's Diarrhea.
Inclusion criteria: inclusion criteria

 Patients were enrolled in the study only if they met all of the following criteria:

 Male and female patients 18 years of age or older

 Female and male patients of childbearing potential must have agreed to use an effective method of birth control (this method must have been approved by the investigator and may have included total abstinence from sexual intercourse) during the treatment and follow-up study periods; female patients of childbearing potential must have had a negative pregnancy test in the 72 hours before randomization; female patients who abstained totally from sexual intercourse were not required to take the pregnancy test

 Recent travel (i.e., must be within 30 days of randomization) from an industrialized country

 Experiencing signs or symptoms indicative of acute bacterial diarrhea (TD), defined as at least three unformed, watery or soft, stools within the 24 hours preceding randomization and the duration of illness 72 hours before randomization, and able to provide an unformed stool sample during Screening (the latter can be the third unformed stool passed by the patient within the 24 hours preceding randomization); the bacterial cause of diarrhea was confirmed by microbiology analysis of the stool sample

 Experiencing one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, or defecation urgency)

 Capable of and willing to give informed consent

Exclusion criteria:

 Patients were excluded from the study if they met any of the following criteria:

 Fever (> 100.4F or 38C) or presence of signs and symptoms of systemic infection Note: antipyretic medication should not have been administered in the 6 hours before this assessment

 Known or suspected infection with non-bacterial pathogen before randomization

 Presence of diarrhea for > 72 hours duration

 Presence of grossly bloody stool

 Presence of moderate to severe dehydration (i.e., presence of orthostatic hypotension and/or dehydration requiring treatment with intravenous fluids)

 History of ulcerative colitis, diarrhea-predominant irritable bowel syndrome, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea. Note: lactose intolerance treated with lactase supplements or a lactose-free diet were not excluded if these regimens were maintained during the study.

 Receiving more than two doses of an antidiarrheal medication (e.g., antimotility, absorbent, adsorbent, antisecretory, or probiotics) within 24 hours before randomization

 Receiving one or more of the following antibiotics, which are active against gram negative bacteria TMP-SMX, fluorquinolone, azithromycin or rifaximin within 7 days before randomization

 Females pregnant or breast feeding or not using adequate birth control

 Known intolerance/hypersensitivity/resistance to rifamycin or rifamycin-related antibiotics or to any excipient included in the study medications

 Patients unable or unwilling to comply with study protocol (e.g., alcoholism, mental illness, travel schedule)

 Participation in a clinical study with another investigational drug in the 30 days prior to randomization or while participating in this study

 Previous participation in this study


Chest X-Ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer

Summary: RATIONALE: Diagnostic procedures such as chest x-ray and chest CT scans may be effective in early detection of lung cancer.~PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a high-risk of developing lung cancer.
Inclusion criteria: DISEASE CHARACTERISTICS: Patients at high risk for the development of lung cancer as defined by the following: At least 40 pack years smoking (may have stopped smoking within past 10 years) at time of study entry FEV-1/FVC ratio less than 70% predicted OR FEV-1 less than 80% predicted obtained from 3 serial performances with less than 5% difference Normal or stable current chest x-ray

 PATIENT CHARACTERISTICS: Age: 40 to 70 Performance status: Not specified Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: See Disease Characteristics Other: No other comorbidity that limits life span to less than 5 years No prior cancer except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Exclusion criteria:

['annual screening', 'bronchoscopic and lung imaging studies', 'comparison of screening methods', 'computed tomography', 'radiography', 'study of high risk factors']

annual screening
bronchoscopic and lung imaging studies
comparison of screening methods
computed tomography
radiography
study of high risk factors


Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia

Summary: This is a study involving the emergency department and outpatient clinics of the David Grant United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of age or older with acute respiratory symptoms and positive or equivocal chest radiographs from October 1, 2004 through May 31, 2005 will be included as positive cases. Controls will be randomly selected from a review of negative chest radiograph reports with a clinical history of an acute respiratory illness over the same time period. Once patients are appropriately identified as control or cases, outpatient charts will be reviewed to gather data on six clinical indicators. Sensitivities and specificities will be calculated for each clinical indicator, to determine which patients require chest radiographs in the setting of suspected community acquired pneumonia (CAP)
Inclusion criteria: inclusion criteria:

 18 years of age or older

 acute respiratory symptoms

 positive chest radiographs

 patients from outpatient clinics and the emergency department

Exclusion criteria: :

 under the age of 18

 suspected hospital-acquired pneumonia (positive radiographs within 10 days of hospital discharge)

 suspected aspiration pneumonia


Effect of Direct Current Polarization on Brain Function

Summary: This study will test a new electrical technique called direct current (DC) polarization that is able to change brain activity in subtle ways for a short time. A recent study showed that, depending on its direction, the current could make people perform a little better or perhaps slightly worse on a test of the function of the brain's frontal lobe. This study will use positron emission tomography (PET) scanning to examine how DC polarization affects brain activity.~Healthy volunteers between 20 and 70 years of age who are right handed and who are not taking any medications that affect the brain may be eligible for this study. Candidates are screened with a brief medical history and neurological evaluation.~Participants have a PET scan on three different days at least 3 days apart. Each scanning session takes 2-1/2 to 3 hours. For the scan, radioactive water is injected into the body through a vein. Subjects lie on a bed that slides in and out of the doughnut-shaped scanner, with their head held from the back by a padded holder and in front by a custom-molded plastic mask with holes for the eyes, nose, and mouth. DC electrodes made of wet sponges are placed on the right side of the head and over the left eye and are held in place with elastic bandages.~Three kinds of DC polarization are tested. In two tests the current is the same, but in opposite directions. The third is a sham (placebo) condition with no current delivered. Each of the three scans is separated by at least 3 days. On each day, a series of scans is done in a single session. Before each injection of tracer, the DC current is turned on. This may cause a tingling or slight burning on the skin under the electrodes, which disappears when the current is turned off. In each session, the subject receives 16 injections of tracer about 8 minutes apart, with DC polarization turned on for 4 out of the 8 minutes.~During most of the 8-minute periods, subjects are shown a pattern of dots about every 2 seconds. Sometimes the subject just looks at the patterns, and sometimes subjects are asked to push a button corresponding to the pattern they saw just before the current one. Sometimes they will be asked to push a button corresponding to the pattern that came before that one and so on, up to three patterns before the current one. The task lasts for about 2 minutes each time, with time to relax in between.
Inclusion criteria: inclusion criteria:

 Participants will be right-handed volunteers, aged 20 to 70, without history of any disorder of the central nervous system.

Exclusion criteria: :

 Current serious medical or psychiatric condition of any kind.

 History of any significant trauma or medical condition affecting the brain or skull.

 History of epileptic seizure.

 Current use of neuroactive medications, medications affecting the cerebral circulation, or recreational drugs.

 Presence of metal in the head (other than dental hardware) or body, such as pacemakers, aneurysm clips, metallic prostheses (including heart valves or cochlear implants), patches with metallic foil backing, such as nicotine patches, permanent eyeliner or shrapnel fragments.

 History of welding or metal work.

 Broken skin in the area of the stimulating electrodes.

 Pregnancy/breastfeeding.


Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure

Summary: Metoprolol succinate is a beta1-selective beta-blocker, becoming non-selective at higher doses, while carvedilol is non-selective. We examined whether metoprolol remained beta1-selective compared to carvedilol during dose up-titration in Class C heart failure (HF) Beta-blocker naïve patients.~METHODS: Twenty-five NYHA FC II-III HF patients were randomized to carvedilol or metoprolol. Patients were studied at baseline and after 2 weeks of up-titration (metoprolol at 25, 50, 100, and 200 mg daily; carvedilol IR at 3.125, 6.25, 12.5, 25 mg and 50mg twice daily). Beta2- blockade was determined by an infusion of terbutaline at 6 mg/kg over 1 hour. Glucose and potassium levels were serially measured at baseline, every 15 minutes for the 1st hour and 30 minutes for 2nd hour post-infusion. The median area under the curve (AUC) for glucose and potassium changes were calculated.
Inclusion criteria: inclusion criteria:

 Patients eligible for the study had objective evidence of systolic dysfunction (ejection fraction ≤40%), were >18 years of age, and were on stable optimal medical heart failure therapy excluding the use of beta-blockers within the previous 30 days.

Exclusion criteria: :

 . Patients were excluded for active viral myocarditis; hemodynamically significant valvular heart disease; hypertrophic cardiomyopathy, peripartum cardiomyopathy; contra-indications to beta-blockers (asthma or obstructive airway disease requiring scheduled bronchodilators or inhaled steroids), resting heart rate <55; supine blood pressure <85/50; second or third degree heart block); concomitant use of beta-agonists, beta-antagonists, or anti-arrhythmics; unstable angina; myocardial infarction or bypass surgery within 3 months; or significant renal insufficiency (creatinine >2.5 mg/dL), liver disease (transaminase levels > 3 fold above laboratory normal), or anemia.


Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

Summary: The aims of this study explore the relationships between cerebral vasospasm, apolipoprotein-E (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that may either intensify or ameliorate secondary injury, for children with a traumatic brain injury. Exploring the apo-E genotype will help us know if injury response is altered in certain children and will aid in developing interventional approaches.
Inclusion criteria: inclusion criteria:

 TBI patients admitted to the pediatric intensive care service (PICU)or pediatric progressive care unit

 Range in age from birth to 15 years

 TBI with a Glasgow Coma Scale of 3-15

 Acoustic window for adequate transcranial doppler (TCD) ultrasound

 English or Spanish speaking or understanding parent/legal guardian to consent

 Access for a buccal swab for genotyping

Exclusion criteria: :

 Non-English or Spanish speaking parents/legal guardian

 Children with a previously diagnosed neurodevelopmental delay


DuraSeal Sealant Post Market Study

Summary: DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).
Inclusion criteria: inclusion criteria:

 Patient is between 18 and 75 years of age

 Patient is scheduled for an elective cranial procedure that entails a dural incision

 Evidence of intraoperative non-watertight closure
Exclusion criteria:

['DuraSeal Dural Sealant System', 'Standard of Care']

DuraSeal Dural Sealant System
Standard of Care

['Elective Cranial Procedures With Dural Incision']


Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics

Summary: The purpose of this preliminary clinical study is to assess the quality of a computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.~Each patient is auscultated and diagnosed independently by a medical specialist by means of a standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm. An echocardiogram is performed as the gold-standard for determining heart pathologies. The results of the computer aided auscultation (CAA) are compared to the findings of the medical professionals as well as to the echocardiogram findings.~Hypothesis: The specific CAA algorithms used in this study are able to differentiate pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric population.
Inclusion criteria: inclusion criteria:

 outpatient

 parental approval for study participation

Exclusion criteria: :

 none

['Heart Murmurs', 'Mitral Valve Prolapse', 'Systolic Murmurs']

Heart Murmurs
Mitral Valve Prolapse
Systolic Murmurs


Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis

Summary: Acute Bacterial Rhinosinusitis (ABRS) is a respiratory inflammation commonly seen in clinical practice, which has with respiratory symptoms including nasal congestion, rhinorrhoea, postnasal discharge and cough and is associated with headache, cheek pain, facial pressure and other conditions. The principal bacterial pathogens in causing ABRS include Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. These three bacteria account for approximately 90% of ABRS in children less than or equal to 5 years of age. Combination of Potassium Clavulanate (CVA) and Amoxicillin (AMPC) produces higher antibiotic activity against beta-lactamase-producing bacteria. The present study is designed to assess the clinical efficacy, bacteriological efficacy and safety of CVA/AMPC (1:14) administered in children aged from 3 months to less than 15 years with ABRS. It is an open-label study consisting of a 7-day treatment phase and a post-treatment follow-up phase for 7 to 14 days.
Inclusion criteria: inclusion criteria:

 Child with ABRS with inflammation as bacterial infection who has the following symptoms/signs on the day of or the day before the first dose of the investigational product: Redness of the nasal mucosa; nasal or postnasal discharge is purulent or mucopurulent; Pathological shadow in the paranasal sinus on a radiogram (only for reference). Patient with surgical history should be excluded but patient with a pervious surgery more than 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy more than 90 days before may be enrolled in the study.

 Child with ABRS whose severity is classified as moderate or severe (total score >=4) based on the nasal cavity findings and symptoms.

 Boy or girl aged >=3 months to <15 years.

 Body weight >=6 kilograms (kg) to <40 kg.

 Written informed consent has been obtained from the child's legally acceptable representative. If the child is 12 years or older, the child him/herself should have also provided written informed consent. The investigator (or sub-investigator) should attempt to obtain written informed consent from the child him/herself as far as possible even if the child is less than 12 years of age.

Exclusion criteria: :

 Severe infection that requires surgical treatment (e.g., child with systemic symptoms such as fever associated with swelling face, child with almost full nasal obstruction due to a large nasal polyp).

 Serious complication such as acute mastoiditis, facial palsy, bacterial meningitis, and brain tumor.

 Congenital disorder such as maxillofacial dysplasia.

 Need of concomitant use of other antibiotics.

 Serious underlying disease (e.g., cardiac disease, malignancy, juvenile diabetes).

 Concurrent infection associated with gastrointestinal symptoms (e.g., diarrhoea, vomiting) that may affect safety assessment.

 Known hypersensitivity to any component of CVA/AMPC or penicillin or cephem antibiotic, or past history of a serious adverse reaction possibly related to any of these agents.

 Infectious mononucleosis.

 Current hepatic impairment, or past history of jaundice or hepatic impairment due to any component of CVA/AMPC.

 Past or current renal impairment (e.g., serum creatinine >=1.5 × Upper Limit of Normal, creatinine clearance of less than 30 milliliter/liter [mL/L]).

 Past or current immune dysfunction or insufficiency, or use of immunosuppressive therapy.

 Need corticosteroid for systemic, eye drops or nasal drops.

 Phenylketonuria.

 Use of azithromycin within 14 days prior to the first dose of the investigational product.

 Use of any antibiotic within 7 days prior to the first dose of the investigational product.

 Current use or imperative use during the study period of probenecid or a tubular secretion inhibitor.

 Participation in another clinical study within 3 months prior to enrollment, or prospected participation in another clinical study during the period of this study.

 Girl with menstruation and childbearing potential, pregnant girl, lactating girl, or girl who is planning a pregnancy during the study period. A girl with childbearing potential may be enrolled in the study only if she is willing to use at least one of the following acceptable measures for contraception throughout the study period: Male partner sterilization prior to the girl's entry into the study, and this male is the sole partner for that girl; Intrauterine device (IUD) (with documented annual failure rate estimate of <1%); Abstinence; Male condom combined with a female diaphragm, either with or without a vaginal spermicide.

 The legally acceptable representative is a minor.

 Child in care.

 History of alcohol or drug abuse.

 Relationship with the study medical institution: The investigator, sub-investigator, study collaborator, person employed by the investigator or the study medical institution, or their close relatives.

 Child whose participation in the study is considered inappropriate by the investigator (or sub-investigator).


Teriparatide Treatment in Patients With Inherited Osteoporosis

Summary: The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.
Inclusion criteria: inclusion criteria:

 inherited low-turnover osteoporosis

 lumbar spine or hip BMD T-score ≤ -2.5

 a written informed consent.

Exclusion criteria: :

 age less than 18 years

 generally accepted contraindications for the treatment


Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers

Summary: The purpose of this study is to determine if HBOT plus standard wound care is more effective than standard wound care alone at preventing the need for major amputation (metatarsal and up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of lower limbs.
Inclusion criteria: inclusion criteria:

 Age > 18 years

 Type 1 or 2 Diabetes Mellitus

 Wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks.

Exclusion criteria: :

 Impending urgent amputation due to ongoing or exacerbated infection;

 Exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed;

 Dialysis-dependent renal failure;

 Any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity;

 History of chemotherapy with use of Bleomycin;

 Participation in another investigative drug or device trial currently or within the last 30 days;

 Current candidates for vascular surgery, angioplasty or stenting;

 Major large vessel disease;

 Undergone vascular surgery or angioplasty within the last 3 months;

 Women who are currently pregnant or are breast feeding or women of childbearing potential who are not currently taking adequate birth control.

['Hyperbaric Oxygen Therapy', 'Placebo Hyperbaric Oxygen Chamber']

Hyperbaric Oxygen Therapy
Placebo Hyperbaric Oxygen Chamber

['Diabetes Mellitus', 'Chronic Ulcers of the Lower Limb']

Diabetes Mellitus
Chronic Ulcers of the Lower Limb


Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects

Summary: Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and cognitive functions in healthy humans.
Inclusion criteria: inclusion criteria:

 Healthy, male and female, aged between 18 and 40, BMI be-tween 19 and 27 kg/m2, normotensive (BP between 90/60 mmHg and 140/90 mmHg), native or fluent German-speaking, caucasian (European ancestry), able and willing to give written informed consent and comply with the requirements of the study protocol, willing to donate saliva sample for DNA-analysis -

Exclusion criteria: :

 Acute or chronic psychiatric or somatic disorder, tachycardia at rest (> 100 bpm), known hypersensitivity to salbutamol, pathological ECG, pregnancy, breast-feeding, long-term medication within last 3 months (oral contraceptives are disregarded) smoking (>3 cigarettes per day), concurrent participation in another study, participation in one of our previous studies using the same memory tests, inability to read and understand the participant's information. -


Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

Summary: The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.
Inclusion criteria: inclusion criteria:

 Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry

Exclusion criteria: :

 Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.

 Lost to follow up.