Clinical Value of Self-assessment Risk of Osteoporosis in Chinese

Summary: This cross-sectional study aimed to validate the effectiveness of the combined use of the Osteoporosis Self-Assessment Tool for Asians (OSTA) and the One-Minute Osteoporosis Risk Test (IOF test) in a population from Wuhan, China.
Inclusion criteria: inclusion criteria:

 age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate.

Exclusion criteria: :

 severe liver, heart, or kidney impairment, and tumor. Procedures of the study were in accordance with the Declaration of Helsinki and were approved by the local ethics committee.


Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma

Summary: This study will evaluate the usefulness of two tests in quickly distinguishing whether a patient with HIV infection and focal brain lesions (an injury in a specific area of the brain) has a rare type of cancer called primary central nervous system lymphoma (PCNSL), or a parasitic infection called toxoplasmic encephalitis.~Toxoplasmic encephalitis is caused by a parasite and can be treated with antibiotics. PCNSL (lymphoma of the brain or spinal cord) must be definitively diagnosed with a brain biopsy (removal of a small piece of brain tissue), and the treatment is radiation therapy and chemotherapy.~The tests under study for diagnosing PCNSL or toxoplasmic encephalitis are measurement of Epstein Barr virus (EBV) DNA in cerebrospinal fluid (CSF) and FDG-PET scan of the brain. EBV is often found in the CSF of people with PCNSL. The study also will compare the accuracy of two imaging techniques-TI-SPECT and FDG-PET-in distinguishing between toxoplasmosis and PCNSL.~Patients 18 years of age and older who have HIV infection and at least one focal brain lesion without a prior history of PCNSL or toxoplasmic encephalitis may be eligible for this study. Each candidate is screened with a medical history, physical examination, blood and urine tests and MRI scans of the brain.~Upon entering the study, all participants take medication to treat toxoplasmic encephalitis. They undergo lumbar puncture (spinal tap) to obtain CSF for analysis, an FDG-PET scan, and a 201TI-SPECT scan. For the PET scan, a radioactive substance is injected into an arm, followed by scanning in a doughnut-shaped machine similar to a CT scanner. SPECT is similar to PET but uses a different radioactive tracer, and the patient lies on a table while the SPECT camera rotates around the patient's head. Patients whose test results indicate a low risk for lymphoma continue antibiotic therapy for toxoplasmosis. They have repeat MRI scans around 4, 7, and 14 days after starting the drug to monitor the response to therapy. Antiretroviral therapy is initiated in patients who are not already on such a regimen.~Patients whose test results indicate a high risk for PCNSL have a CT scan to look for evidence of lymphoma elsewhere in the body and are referred for consultation with a neurosurgeon to discuss undergoing a brain biopsy. The brain biopsy is done in the operating room under general anesthesia. A small cut is made in the scalp and a small opening is made in the skull over the area of the brain to be biopsied. A needle is placed in the opening in the skull and, guided by CT or MRI, moved to the abnormal area of the brain, where a small piece of tissue is removed for study under a microscope.~Patients found to have toxoplasmosis are discharged from the hospital to the care of their primary care physician after they are getting better and are tolerating all their medications. They return to NIH for follow-up visits about 4 weeks, and 6 months after discharge.~Patients found to have lymphoma are referred to the National Cancer Institute for screening for enrollment in a treatment protocol. Patients who are not eligible for a treatment protocol are referred back to their primary care physician or for another NIH treatment protocol, if one is available. Patients with lymphoma are seen at the NIAID outpatient clinic for follow-up visits and laboratory examinations every 3 months for 2 years.
Inclusion criteria: inclusion criteria:

 Adult (18 years old or older) HIV-infected patient

 HIV infected by OraQuick rapid test using saliva, venipuncture whole blood, or fingerstick whole blood; or by reactive ELISA and Western Blot as determined by an outside CLIA-approved laboratory facility or by NIH Clinical Pathology Laboratory or SAIC-Frederick Inc Monitoring Laboratory. HIV infection as determined by an outside CLIA-approved laboratory facility will be verified by a standard HIV-1 ELISA with Western Blot confirmation prior to brain biopsy.

 Evidence of contrast-enhancing focal brain lesion(s) as seen on MRI or CT

 Willingness to give informed consent and provided by Durable Power of Attorney. In the event that no Durable Power of Attorney has been designated and the patient is unable to do so, the NIH Ethics Committee will be consulted. All patients must designate a Durable Power of Attorney in order to participate in the study.

 Willingness to undergo the procedures involved in the diagnostic evaluation: lumbar puncture, FDG-PET scan, 201Tl-SPECT scan, and brain biopsy.

 Permit the storage of blood, CSF, and tissue samples for future research use

 Willingness to undergo HLA testing

Exclusion criteria: :

 Previous PCNSL

 History of prior malignancy other than PCNSL unless in remission for 1 year or longer; non-melanoma skin cancer and Kaposi's sarcoma excepted

 History of previous diagnosis of toxoplasmic encephalitis or other CNS infection causing focal contrast-enhancing brain lesions

 Pregnancy or currently breast feeding

 Have any other condition that the research team considers a contraindication to participating in the study, e.g. severe cardiac, renal, or pulmonary dysfunction.

 Weight greater than 400 lb for PET and 500 lb for SPECT (limit of the gantry).

['HIV Infections', 'Lymphoma, AIDS-Related']


Notification of Donors With Positive Microbiology Markers

Summary: Each year around 200 blood donors in the UK are found to be infected with blood-borne diseases (HIV, hepatitis B, hepatitis C, and HTLV), while several others have been identified as having an increased risk of variant Creutzfeldt-Jakob Disease (vCJD). Although the notification procedures for these infections vary, their effectiveness and appropriateness have never been evaluated in a systematic study.~The proposed research has been designed to assess the responses of blood donors to notification and their satisfaction with how they were informed about the infection. The study will be implemented using standard questionnaire-based measures (French et al, 2004; Marteau & Bekker, 1992).~The study will involve approximately 600 blood donors who were informed of an infection or possible infection with blood-borne diseases in 2008 and 2009, and approximately 100 donors notified of possible risk of vCJD infection in 2005. A comparable group of 2005 donors will be included to control for the effects of time. As the majority of donors testing positive donated to NHS Blood and Transplant (NHSBT), the participants will be identified from the NHSBT database only, and their availability confirmed through their GP or specialist clinician. A standardized questionnaire will be then sent to all those identified as eligible.~The study will last 12 months, but direct participant involvement will be limited to the time required to complete the questionnaire, which should take under one hour. To safeguard confidentiality, no identifiable personal data will be used in the analysis. Where demographic or medical information already held by NHSBT is retrieved to minimise response burden, this will be pseudonymised before use.~The study is sponsored by the blood services for England, Wales, Scotland and Northern Ireland. The results will be used to inform notification procedures in the future.
Inclusion criteria: inclusion criteria:

 deferred blood donor status, and

 deferral due to a positive result of a routine blood test for HIV, or hepatitis B, or hepatitis C, or HTLV, or having been identified as at risk of vCJD; and

 deferral occured in 2008 or 2009 (2007 for the pilot; 2005 for those at risk of vCJD); and

 donor registered at one of the NHSBT centres (English Blood Service in England and Wales);

Exclusion criteria: :

 not a blood donor; or

 no record of notification having taken place; or

 a member of Armed Forces or other profession where contact at the address provided could lead to a breach of confidentiality; or

 deferred before 2008 (if not in the pilot or notified of increased risk of vCJD);

 deferred as a result of a non-routine test or syphilis infection only; or

 donor registered with and notified by the Welsh, Scottish or Northern Irish Blood Services;

['Human Immunodeficiency Virus', 'Hepatitis B', 'Hepatitis C', 'Human T-lymphotropic Virus I & II', 'Creutzfeldt-Jakob Syndrome']

Human Immunodeficiency Virus
Hepatitis B
Hepatitis C
Human T-lymphotropic Virus I & II
Creutzfeldt-Jakob Syndrome


Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy

Summary: The aim of the present study is to compare patient's recovery times after elective colonoscopy employing remifentanil only vs conventional combination of midazolam and meperidine
Inclusion criteria: inclusion criteria:

 Aged 19-65 years

 American Society of Anesthesiologists physical status (ASA PS) 1-2

 Patients scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital

 Patients who signed on written informed consent.

Exclusion criteria: :

 The

['Remifentanil', 'Midazolam', 'Meperidine', 'placebo (for remifentanil)', 'placebo (for midazolam)', 'placebo (for meperidine)']

Remifentanil
Midazolam
Meperidine
placebo (for remifentanil)
placebo (for midazolam)
placebo (for meperidine)


Scalp Cooling to Prevent Chemo-induced Hair Loss

Summary: Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.
Inclusion criteria: inclusion criteria:

 New diagnosis of breast cancer stage 1-2

 Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent

 Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen,

 Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses

 Concurrent traztuzumab at standard doses is allowed

 Concurrent pertuzumab at standard doses is allowed

 Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.

 Subjects must have TSH collected within 1 year prior to treatment and found within normal range.

 If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits.

 CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits.

Exclusion criteria: :

 Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)

 Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale)

 Subjects with cold agglutinin disease or cold urticaria

 Subjects who are scheduled for bone marrow ablation chemotherapy

 Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)

 Male gender

 Age >= 70 years

['PAXMAN Orbis Scalp Cooler', 'Control No treatment']

PAXMAN Orbis Scalp Cooler
Control No treatment


A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.

Summary: This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Inclusion criteria: inclusion criteria:

 adult patients, >=18 years of age;

 chronic hepatitis C, genotype 1;

 insulin resistance.

Exclusion criteria: :

 other forms of liver disease;

 cirrhosis;

 previous treatment for chronic hepatitis C;

 insulin treatment during prior 2 weeks;

 type 1 diabetes.

['peginterferon alfa-2a [Pegasys]', 'ribavirin [Copegus]', 'Pioglitazone']

peginterferon alfa-2a [Pegasys]
ribavirin [Copegus]
Pioglitazone


Continuous Topical Instillation for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections

Summary: The closed systems, such as conventional negative pressure wound therapy (NPWT), were usually avoided in infected or critical colonized wounds. To our observation, the additional continuous irrigation tube attached beside the suction tube in the NPWT system could provide the effective drainage by reducing the occlusion of suction tube, enable effective debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by providing relatively moist ambient. At our institutions, the modified system combined with a triple-tube device to allow a continuous instillation became more active and efficient. The study is to investigate if a continuous triple-tube instillation and suction could improve the outcomes of acute severely infected open abdomen.
Inclusion criteria: inclusion criteria:

 age ≥ 18 years patients with complicated intra-abdominal infections who needed open abdomen (OA) and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM)

 Eligible patients were properly consented before enrollment. If the patient was incapable, the patient's legal representative was asked to provide consent on the patient's behalf.

 Patients with grade 1b (contaminated OA without adherence between bowel and abdominal wall), 2b (contaminated OA developing adherence) open abdomen, as classified by Bjorck.

Exclusion criteria: :

 < 18 years,

 pre-existing large ventral hernia

 Frozen OA with adherent bowel (OA of grade 4),

 Clean wound (OA of grade 1a or 2a)

 chronic wound infection

 critical wound ischemia

 severe systemic infection

 end-stage renal disease

 severe liver disease

 uncontrolled diabetes mellitus

 any issue with an obviously high risk of delayed wound healing

['Continuous topical triple-tube irrigation and suction', 'SOC']


PPSV23 Pneumococcal Vaccine in Chronic Obstructive Pulmonary Disease (COPD)

Summary: Streptococcus pneumoniae is the most common causes of community-acquired pneumonia and exacerbations in chronic obstructive pulmonary disease (COPD) patients, which are associated with morbidity, mortality, and higher health-care cost. In addition, recently high daily dose of inhaled corticosteroid (ICS) therapy became more evident to be beneficial in moderate-to-severe COPD patients, but excess risk of pneumonia shown in database analysis was worried about by primary physicians. The use of pneumococcal polysaccharide vaccination (PPSV23) has protective efficacy to eliminate infection of Streptococcus pneumoniae from previous studies. If the use of PPSV23 can reduce the incidence of pneumonia or exacerbations in COPD patients using high daily dose of ICS, the benefit of ICS can be preserved and risk of pneumonia can be reduced. However, there is only limited data supporting this hypothesis. In this study, the investigators will conduct a double-blinded, randomized controlled trial to evaluate the clinical efficacy of PPSV23 in severe COPD patients using high daily dose of ICS.
Inclusion criteria: inclusion criteria:

 no previously vaccination with PPSV23,

 a clinical diagnosis of severe COPD which is defined according to the GOLD 2006 guideline (11): FEV1/FVC < 70%, FEV1 reversibility test < 200 ml, and FEV1 < 50% of predicted,

 current or past exposure of smoking,

 no exacerbation in the month prior to enrollment,

 age < 65 years,

 using high daily dose of ICS (budesonide > 800-1600 mcg/day or fluticasone > 500-1000 mcg/day),

 providing written informed consent.

Exclusion criteria: :

 Patients are excluded from the study if they are pregnant, or have immunosuppressed status (known current neoplasm, renal insufficiency in dialysis, human immunodeficiency virus (HIV) infection, severe hepatic impairment, hypogammaglobulinemia, anatomical or functional asplenia).

 Asthma, cystic fibrosis, bronchiectasis, and severe sequelae of pulmonary tuberculosis are also excluded by pulmonary function study and chest imaging before patient's enrollment.

['PPSV23 pneumococcal vaccine (Pneumovax®)', 'Normal Saline']

['Chronic Obstructive Pulmonary Disease']


Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

Summary: This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection. When a pregnant woman is infected with CMV, her immune system (which protects her from infection) is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine, vaginal secretions). The aim of this study is to find out if there is a link between either the pregnant woman's immune response or the presence of the virus in these bodily fluids and the child/foetus being infected with the virus.
Inclusion criteria: inclusion criteria:

 Subjects who the investigator believes that they can and will comply with the requirements of the protocol .

 A pregnant female, 18 years of age or older at the time of study enrolment.

 Women with confirmed primary CMV infection.

 Written informed consent obtained from the subject.

Exclusion criteria: :

 Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry.

 Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product.

 Previous vaccination against CMV infection.

 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination

 Major congenital defects, serious chronic illness or organ transplantation.

 Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy.

 Documented Human immunodeficiency virus (HIV)-positive subject.

 Gestational age of more than 34 weeks, as determined by foetal ultrasound.

['Blood sample', 'Cord blood sample', 'Saliva swab', 'Urine sampling', 'Vaginal swab']

Blood sample
Cord blood sample
Saliva swab
Urine sampling
Vaginal swab

['Infections, Cytomegalovirus', 'Cytomegalovirus Infections']

Infections
Cytomegalovirus
Cytomegalovirus Infections


Making Memory Better for Seniors With Mild Cognitive Impairment

Summary: The purpose of this study is to investigate the feasibility and effectiveness of a cognitive training group in individuals with Mild Cognitive Impairment, using a new paradigm that will optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing traditional memory training with the teaching of an empirically-supported problem-solving approach, and (3) employing a clinically representative sample of individuals with MCI (e.g., not excluding those with mild affective symptoms).
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of Mild Cognitive Impairment

Exclusion criteria: :

 Clinical diagnosis of dementia

 History of neurological conditions known to impair cognition

 History of alcohol or drug abuse

 History of chronic psychiatric illness

 Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15)


Outpatient Treatment of Low-risk Pulmonary Embolism

Summary: This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.
Inclusion criteria: inclusion criteria:

 Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan

 Total Pulmonary Embolism Severity Index (PESI) score <86

Exclusion criteria: :

 Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram

 Sustained Systolic Blood Pressure (SBP) <95 mmHg during Emergency Department or observation stay.

 Age <18

 Pregnant

 Renal insufficiency (Creatinine Clearance <30)

 Hepatic Dysfunction (AST/ALT/ALP > 3 times upper limit of normal)

 Unreliable social situation or inability to follow up

 Contraindication to enoxaparin, warfarin and rivaroxaban

 Atrial or ventricular dysrhythmia(s)

['Outpatient Treatment of Pulmonary Embolism']


Zinc Lozenges and Their Effect on Postoperative Sore Throat Syndrome

Summary: The objective of this study is to assess the effect of preoperative administration of oral zinc lozenges on the incidence of postoperative sore throat syndrome.~When patients undergo surgery with general anesthesia, they require ventilation of their lungs with the help of a flexible tube (called an endotracheal tube) that is placed through the mouth, passing the vocal cords, and into the windpipe (trachea). This tube helps oxygenate the patient, delivers anesthetic gas to the lungs, and keeps the airways open to prevent asphyxiation. The procedure is invasive and uncomfortable, and one of the most common consequences is a sore and inflamed throat after the tube is taken out. This is termed postoperative sore throat (POST). Though the intensity and severity of sore throat varies from person to person, the reported incidence is as high as 90% of patients undergoing general anesthesia.~Zinc therapy has been shown in multiple studies to reduce the severity and duration of cold symptoms, and also to up-regulate the immune system. Recent studies have shown that zinc can act as an anti-inflammatory agent and can maintain the integrity of skin and mucosal membranes (which cover the inside of the mouth and throat). The aim of this study is to evaluate the effects of giving zinc lozenges before tube placement on postoperative sore throat.~After written informed consent is received in pre-op, a sealed and coded envelope with either the zinc lozenge or the placebo lozenge will be given to the patient to be administered orally, with the instruction to dissolve the lozenge by sucking on it 30 minutes prior to surgery. Upon completion of surgery and emergence from general anesthesia, the patient will be extubated and transferred to the post-anesthesia care unit (PACU). Once in the PACU, the patient will be assessed regarding the incidence and severity of POST by the study investigator using a standardized scale. The severity of POST will be graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). This evaluation will be performed at 30 minutes, 2 hours, 4 hours, and 24 hours post-surgery, with the assessment at 4 hours being the primary outcome of the study.
Inclusion criteria: inclusion criteria:

 Men and women ages 18 and older

 American Society of Anesthesiologists physical status classification system I and II (healthy patient or patient with mild systemic disease)

 Patient coming for elective surgery (except head and neck) requiring general anesthesia

 Patients staying for at least 24 hours postoperatively

 Patients provide informed consent

 Patients presenting for surgery >1 hour in length and <6 hours.

Exclusion criteria: :

 History of preoperative sore throat, common colds, upper respiratory infections, immune deficiencies

 Chronic smokers

 Patients with Mallampati airway grade of more than 2

 Patients requiring more than one attempt for intubation or traumatic intubations

 Patients requiring laryngeal mask Airway (LMA) placement

 Patients allergic to zinc

 Patients requiring quinolones or tetracycline antibiotics pre- or intraoperatively

 Patients undergoing head and neck surgeries

 Pregnancy

['Sore Throat', 'Post-Operative Sore Throat']


Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude

Summary: In this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema.
Inclusion criteria:
Exclusion criteria: :

 acute clinically significant inter-current diseases

['Breathing procedure 1', 'Breathing procedure 2']

Breathing procedure 1
Breathing procedure 2


Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men

Summary: The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV) types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.
Inclusion criteria: inclusion criteria:

 MSM with HIV negative

 MSM with HIV positive
Exclusion criteria:


Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension

Summary: Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation.~The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure.~The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization.~The study will run for 18 months and it will be necessary to recruit 50 patients.~All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria.~The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups.
Inclusion criteria: inclusion criteria:

 Patients with pulmonary artery hypertension (group 1 of the Nice classification of pulmonary hypertension)

 Aged over 18 years old

 NYHA class III or IV

 Not controlled by optimal medical management as defined by:

 dual therapy including a prostacyclin.

 or dual therapy including an endothelin receptor antagonist and a

 5-phosphodiesterase inhibitors, in patients with contra-indication of prostacyclin, poor tolerance to this treatment, prostacyclin derivative treatment failure or patient refusal.

 Valid status in the social security system

 Signed informed consent

Exclusion criteria: :

 Patient eligible for pulmonary transplantation

 Pregnancy or breastfeeding

 Adults of the age of majority subject to guardianship court order or deprived of liberty

 Patient with history of radio frequency procedure

 Known heparin allergy


Neurological Outcome in Patients of Traumatic Subarachnoid Haemorrhage

Summary: Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and pattern of traumatic brain injury varies in developed and developing countries. Subarachnoid haemorrhage refers to blood in subarachnoid space that lies between arachnoid and piameninges, covering brain. It is often associated with concurrent intracranial injury component. Individuals at higher risk for tSAH are those who are at higher risk for blunt head trauma. This includes adolescents, low-income individuals, men, and individuals with a history of substance abuse. The investigators present study aims to investigate prognostic factors associated with the neurological outcome among patients of post traumatic SAH.
Inclusion criteria: inclusion criteria:

 All patients of traumatic subarachnoid haemorrhage

Exclusion criteria: :

 Metabolic disorder

 Altered coagulation profile

 Cardiac disease

 Co- morbid illness


Nasogastric/Orogastric Tube Placement Verification Study Using RightSpot pH Indicator to Verify Gastric Acidity

Summary: This study will evaluate the use of RightBio Metrics' RightSpot device used to determine if there is proper placement of a nasogastric or orogastric tube.
Inclusion criteria: inclusion criteria:

 Patients 18 years and older

 Patient or proxy willing to provide informed consent

 Patients who require placement of a nasogastric/orogastric tube, in the ED or ICU, as standard of care, AND a member of the study staff is available and present for NG/OG tube placement.

 It is anticipated that the patient will remain in the ED/ICU in order to obtain RightSpot pH Indicator reading and verifying CXR

Exclusion criteria: :

 Patients less than 18 years of age

 Patient or proxy unwilling or unable to provide informed consent

 Patient with known or suspected pregnancy

['RightSpot pH Indicator', 'Chest radiograph']

['Small Bowel Obstruction', 'Gastrointestinal Hemorrhage']

Small Bowel Obstruction
Gastrointestinal Hemorrhage


Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism

Summary: The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder
Inclusion criteria: inclusion criteria:

 informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder,

Exclusion criteria: :

 pregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, T-score below -3.5, thyroidea ophthalmopathy with indication for steroids,


Epidemiology of Venous Thromboembolism

Summary: More than 5 years ago the DVT FREE Registry was conceived. Its database consists of 5,451 ultrasound-confirmed DVT patients from 183 institutions. This database is rich in information of critical importance to health care providers. The information contained within the database will be revisited to provide more detailed analyses which will be used for risk factor assessment and for decision-making regarding the implementation of VTE Prophylaxis.
Inclusion criteria: inclusion criteria:

 Ultrasound-confirmed DVT patients from 183 institutions.
Exclusion criteria:

['Venous Thromboembolism', 'Pulmonary Embolism', 'Cancer', 'Deep Vein Thrombosis', 'COPD']

Venous Thromboembolism
Pulmonary Embolism
Cancer
Deep Vein Thrombosis
COPD


Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism

Summary: The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.
Inclusion criteria: inclusion criteria:

 First episode of major unprovoked VTE

 VTE objectively proven

 VTE treated for 5-12 months with anticoagulant therapy authorized for the REVERSE II study (initial or ongoing therapy)

 Absence of recurrent VTE during the treatment period

Exclusion criteria: :

 Less than 18 years of age

 Patients who have already discontinued anticoagulant therapy

 Patients requiring ongoing anticoagulation for reasons other than VTE

 Being treated for a recurrent unprovoked VTE

 Patients with high risk thrombophilia

 patients who plan on using exogenous estrogen(OCP,HRT)if anticoagulant therapy is discontinued

 Patients with pregnancy associated VTE

 Geographically inaccessible for follow-up

 Patients unable or unwilling to provide informed consent

['Application of theMen continue and HER DOO2 rule']


Delirium Recall in Advanced Cancer Patients

Summary: Primary Objectives:~To determine the proportion of patients who experience partial or complete recollection of symptoms of delirium and the level of distress associated with this recall.~To determine caregiver's level of distress associated with the patient's episode of delirium.
Inclusion criteria: inclusion criteria:

 Presence of advanced cancer, defined as local recurrent and/or metastatic.

 History of an episode of delirium during the patient's current inpatient admission, diagnosis of delirium will be made by one of the palliative care specialists according to DSM-IV-TR criteria.

 If the patient has a complete recovery from the episode of delirium, the patient must be approached within 3 days for the possibility of inclusion in study. Complete recovery will be defined as diagnosis of complete resolution of all symptoms of delirium according to DSM-IV-TR criteria by one of the palliative care specialists.

 Ability to communicate in the English language.

 Caregiver who is 18 years of age or older (assessments used in this study have not been validated in pediatric population), is able to communicate in English and comprehend the assessment questionnaire, and is at the bedside for a significant length of time (approximately 4 hours) each day during the delirium episode. Both the patient and their caregiver must agree to participate for inclusion in the study.

 Written informed consent signed by the patients and the participating caregivers.

 MDAS [Memorial Delirium Assessment Scale] < 13 (Scores of 13 or above likely reflect the presence of delirium).

 Patients will be recruited from the palliative care mobile team or the inpatient palliative care unit.

Exclusion criteria: :

 Refusal of both the patient and their caregiver to complete assessments

 Inability to complete assessment due to sensorial deficits other than cognition; e.g. blindness, deafness, aphasia, etc., that might impact the patient's ability to recall the episode of delirium.


A Phase II Study of ACZONE™ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash

Summary: The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face
Inclusion criteria: inclusion criteria:

 To be eligible for the study, subjects must fulfill all of the following criteria:

 Be male or female ≥18 years of age (inclusive).

 Have been prescribed Tarceva as a single agent to treat locally advanced or metastatic NSCLC, after failing at least 1 prior chemotherapy regimen.

 Present with acute signs and symptoms of rash on the face that meet the following criteria:

 Are suspected to be related to Tarceva,

 Include at least 3 inflammatory lesions, and

 Are less than CTCAE Grade 3 in severity.

 Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤2 and a life expectancy of at least 4 months.

 Sign an approved informed consent form for the study.

 Be willing to comply with the protocol.

Exclusion criteria: :

 Subjects meeting any of the following criteria will be excluded from the study:

 A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that, in the study physician's opinion, would confound the evaluation of the rash.

 A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal.

 A diagnosis of anemia, defined as hemoglobin <9.5 g/dL.

 Undergoing any current therapy for NSCLC other than Tarceva.

 Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor.

 Treatment with topical antibiotics, topical steroids, and other topical treatments on the face within 14 days of Day 0 (start of ACZONE/placebo study treatment).

 Treatment with any systemic antibiotics within 7 days of Day 0 (start of ACZONE/placebo study treatment).

 Treatment with any systemic medication or therapy known to affect anti-inflammatory responses within 30 days prior to Day 0 (start of ACZONE/placebo study treatment). These medications include, but are not limited to, oral corticosteroids, cyclosporine, and methotrexate. Short-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) before the study for non-rash related conditions is acceptable, provided that exposure is limited to ≤7 days per course. Chronic low-dose aspirin use is also acceptable.

 Active participation in an experimental therapy study or received experimental therapy within 30 days of Day 0 (start of ACZONE/placebo study treatment).

 A history of hypersensitivity to dapsone, sulfamethoxazole, trimethoprim, parabens, or any component of ACZONE.

 A poor medical risk because of other systemic diseases or active uncontrolled infections.

 Women who: are lactating; have a positive pregnancy test at Day 0, or; if sexually active and menstruating, are not practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD); oral, dermal (patch), implanted or injected contraceptives; tubal ligation or hysterectomy (medical documentation required); and/or barrier methods with spermicide. A surgically sterile partner is not considered an adequate method of birth control.

['ACZONE (dapsone) Gel, 5%', 'Vehicle Control']


Animal-assisted Interventions in Health Promotion for Elderly With Dementia

Summary: The overall research aim of this study is to investigate changes in measures related to the risk of falls among elderly with dementia participating in animal-assisted interventions. Also relatives' experience of own and the elderly's situation during and after the intervention will be examined. The design will be a prospective and cluster randomized multicenter trial, but mixed-methods will be used to target different outcomes. The study population will be elderly (age above 65) at day care centers diagnosed with dementia, or having a cognitive deficit. The intervention will consist of 30 minutes sessions with animal-assisted activity or animal-assisted therapy two times a week for 12 weeks in groups of 4-6 participants. Control groups will receive treatment as usual. Research questions:~Is there an effect in use of ordinary and optional medication among elderly persons with dementia at day care centers participating in animal-assisted interventions compared to a control group?~Is there an effect on social interaction, quality of life, activeness and wellbeing among elderly persons with dementia at day care centers participating in animal-assisted interventions compared to a control group?~Is there an effect on balance among elderly persons with dementia at day care centers participating in animal-assisted therapy compared to animal-assisted activity or a control group?~Do relatives of elderly persons with dementia at day care centers experience a change in their own and the elderly's situation after the intervention compared with before the intervention started?
Inclusion criteria: inclusion criteria:

 Diagnosis of dementia or having a cognitive deficit measured as a score less than 25 on Mini-Mental State Examination.

Exclusion criteria: :

 Fear of dogs, dog allergy or need of wheel chair

['Animal-assisted activity', 'Animal-assisted therapy']

Animal-assisted activity
Animal-assisted therapy


TRIAD - Treatment of Insomnia and Depression

Summary: The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.
Inclusion criteria: inclusion criteria:

 Meets criteria for Major Depressive Disorder

 Between 18 and 75 years of age and adequately fluent in English

 Meets criteria for an insomnia disorder

Exclusion criteria: :

 Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.

 People for whom the antidepressant medication(s) provided in the study is not indicated

 People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.

 People with uncontrolled medical conditions.

 People with moderate or severe sleep disorders other than insomnia

 Individuals on a fixed night shift or rotating work schedule that requires a night shift.

 Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.

['Antidepressant', 'Desensitization Therapy for Insomnia', 'Cognitive Behavioral Therapy for Insomnia']

['Sleep Initiation and Maintenance Disorders', 'Depression']


The Effectiveness of Varicella Vaccination in Children in Germany

Summary: This study is undertaken to evaluate the effectiveness of currently licensed varicella vaccines under conditions of routine use in a setting where varicella vaccine is included in the childhood immunization calendar.
Inclusion criteria: inclusion criteria:

 Male or female child at least one year of age, born on or after July 1 2003.

 Residence in Germany

 At least one previous well-child visit to the practice

 Written informed consent obtained from parents/guardians of the subject as per local requirements.

 Specific inclusion criterion for cases:

 Suspected primary varicella disease (i.e. chickenpox) at the time of study entry

Exclusion criteria: :

 Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are:

 History of hypersensitivity to any of the components of the vaccines

 Congenital or acquired immunodeficiency

 Treatment with immunosuppressive therapy

 HIV-infected patients, when CD4 < 25% of total lymphocytes

 Previous history of chickenpox by physician record or parental report.

 Lack of documented vaccination history (written or computerised practice records or child's vaccination card/booklet).

['Varicella (chickenpox) lesion sampling']

['Varicella (Chickenpox)', 'Chickenpox Vaccines']

Varicella (Chickenpox)
Chickenpox Vaccines


Congestive Heart Failure Trends in the Elderly 1970-94

Summary: To investigate trends in the incidence and survival rates of congestive heart failure (CHF) in two successive cohorts of elderly people (1970-74, 1990-94) in a health maintenance organization (HMO).
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Heart Diseases', 'Heart Failure, Congestive', 'Heart Failure']

Cardiovascular Diseases
Heart Diseases
Heart Failure
Congestive
Heart Failure


Massage Therapy in Juvenile Idiopathic Arthritis

Summary: While there has been progress in juvenile idiopathic arthritis (JIA) management, there is no cure. Despite receiving standard of care, many children live with pain. Thus, it is not surprising that families turn to complementary and alternative medicines (CAM) therapies, including massage therapy (MT). Little is known about the efficacy of MT in JIA.~In this project, a massage therapist will teach parents how to provide a massage to their child with JIA at bedtime, at home. The feasibility of establishing a home MT program for children with JIA will be evaluated. In addition, the effects of MT on JIA will be examined.~This proposal is relevant to JIA families, who ask questions on MT to professionals of the JIA clinic.~Beyond providing education to JIA families, this project demonstrates the team approach to JIA management. Team members will include a pediatric rheumatology nurse and a massage therapist.
Inclusion criteria: inclusion criteria:

 Diagnosis of JIA (ILAR classification)

 Age 5 to 17 years

 Ability to speak/read French or English; one caregiver per child will be recruited;

 Presence of pain, defined as: pain reported by the child and/or caregiver, and/or joint tenderness and/or stress pain in at least 1 joint during physical examination performed by rheumatologist. Pain reported by the child/caregiver is not a prerequisite because some children develop behaviors and guarding postures to avoid pain

 Absence of anticipated change in treatment. If, during the study, a change in treatment is necessary, the change will be recorded but the child will not be withdrawn

 Stable dosages of medications and absence of intra-articular corticosteroid injections for 4 weeks prior to enrolment

 Eligibility confirmed by child's rheumatologist.

Exclusion criteria: :

 No current MT

 Systemic arthritis with quotidian fevers

 Acute infection

 Open skin lesion

 Fibromyalgia

 Sleep apnea

 Medications: anticoagulants, muscle relaxants, analgesic medications (acetaminophen allowed)

 Pregnancy.


Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates

Summary: Introduction:~Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized the need to improve collaborations between neonatologists and nephrologists within and across centers. The investigators have created a multi-institutional, multi-disciplinary group, Neonatal Kidney Collaborative (NKC), in order to address the following critical needs identified at the workshop: AWAKEN is the inaugural study of this new collaboration.~Development of a standardized evidence-based definition of neonatal AKI~Evaluation of risk factors that predispose neonatal to AKI~Investigation into how fluid provision/ balance impacts biochemical and clinical outcomes
Inclusion criteria: inclusion criteria:

 All infants born or admitted to a level 2 or 3 NICU will be screened.

 Infants who received intravenous fluids for > 48 hours will be eligible.

Exclusion criteria: :

 Infants admitted to the NICU at 2 weeks of age or older

 Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life

 Infants diagnosed with a lethal anomaly upon admission

 Infants who die within 48 hours after birth


Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

Summary: Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality, in the absence of strong research support. This study aims to investigate the effect of NMES therapy for dysphagia upon recovery of swallowing function following stroke. The study will follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute rehabilitation facility will be clinically screened for dysphagia, and randomized into one of three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be monitored. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke, and has the potential to enable more efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to stroke patients, and the community.
Inclusion criteria: inclusion criteria:

 Stroke identified by neurological and radiological examination

 Oropharyngeal dysphagia as confirmed by clinical and radiological examination

 No prior history of oropharyngeal dysphagia by patient and/or caregiver report

 No previous head/neck surgery or trauma that may impact swallowing ability

 No other/concomitant neurological disorders (e.g. Parkinson's disease) that would impact oropharyngeal swallowing ability. This does not include post-stroke deficits.

 Physician and patient/family agreement to participate.

Exclusion criteria: :

 Exposed to previous behavioral or NMES swallowing therapy within 6 months of admission

 Presence of progressive neurological disorder, such as ALS; Parkinson's or other neurologic disorders within the last 6 months;

 History of neurosurgery (either ablative or stimulatory), encephalitis or significant head trauma.

 History of a significant medical condition such as heart, liver, or renal disease; history or evidence of malignancy within the past 5 years other than excised basal cell carcinoma.

 Because of FDA Warnings, patients with cardiac demand pace makers will be excluded.

 Patients with evidence of significant cognitive impairment or dementia as reflected in a Mini-Mental test less than 23 and/or a score of 50% or less on the comprehension quotient on the Western Aphasia Battery.


Dose of Corticosteroids in COPD

Summary: COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by long-term smoking. COPD can get worse, making people sick enough to need hospitalization. Corticosteroids are very effective and are almost always used, but nobody knows the right dose. High doses may work better but could cause more side effects than low doses. Typical treatment lengths last at least one week. This study will be comparing two common regimens: either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high dose). It is unknown which regimen works better..
Inclusion criteria: inclusion criteria:

 i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age ≥ 40 years-old iii. Smoking history ≥ 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital

Exclusion criteria: :

 i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices.

 vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation.

['Low Dose Corticosteroids', 'High Dose Corticosteroids']

Low Dose Corticosteroids
High Dose Corticosteroids


APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

Summary: The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.
Inclusion criteria: inclusion criteria:

 Male or female of 18 to 85 years of age (inclusive);

 Have a diagnosis of FAP

 Neuropathy Impairment Score requirement of 5-130

 Meet Karnofsky performance status requirements

 Have adequate complete blood counts and liver function tests

 Have adequate cardiac function

 Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV)

Exclusion criteria: :

 Had a prior liver transplant or is planned to undergo liver transplant during the study period;

 Has untreated hypo- or hyperthyroidism;

 Has known human immunodeficiency virus (HIV) infection;

 Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated;

 Recently received an investigational agent or device

 Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid

['patisiran (ALN-TTR02)', 'Sterile Normal Saline (0.9% NaCl)']

patisiran (ALN-TTR02)
Sterile Normal Saline (0.9% NaCl)

['TTR-mediated Amyloidosis', 'Amyloidosis, Hereditary', 'Amyloid Neuropathies, Familial', 'Familial Amyloid Polyneuropathies', 'Amyloid Neuropathies', 'Amyloidosis, Hereditary, Transthyretin-Related']

TTR-mediated Amyloidosis
Amyloidosis
Hereditary
Amyloid Neuropathies
Familial
Familial Amyloid Polyneuropathies
Amyloid Neuropathies
Amyloidosis
Hereditary
Transthyretin-Related


Viral Infections in BAL and Bronchial Biopsies of Stable COPD Patients

Summary: Background: The presence of low-grade viral infection in the airways of patients with stable chronic obstructive pulmonary disease (COPD) could potentially have implications in the pathogenesis and progression of the disease, but previous studies have reported very different rates of human rhinovirus (HRV) and respiratory syncytial virus (RSV) genome detection in nasal and sputum samples. However, no study has investigated the presence of these viruses directly in the lungs by bronchoalveolar lavage (BAL) and bronchial biopsies. This study aimed to investigate whether HRV and RSV are present in the lungs of stable COPD patients by performing BAL and bronchial biopsies, and relate their presence with disease severity.~Methods: Consecutive patients with stable COPD and control subjects, who underwent diagnostic (e.g., lung cancer) and/or therapeutic (e.g., hemoptysis) fibreoptic bronchoscopy in a university hospital in Athens, Greece, were enrolled. The collected BAL and bronchial biopsies during bronchoscopy were subsequently processed for HRV and RSV RNA detection with real-time polymerase chain reaction (PCR). More specifically, the nucleocapsid gene and 5΄ non-coding region were searched for RSV and HRV detection, respectively.
Inclusion criteria: inclusion criteria:

 stable COPD,indication for bronchoscopic procedure

Exclusion criteria: :

 atopic history, asthma, extensive pleural effusions, bronchiectasis, immunosuppression due to chemotherapy or systemic corticosteroids and all the contraindications of the bronchoscopic procedures

['HRV and RSV Presence in the Lungs of Stable COPD Patients.']


Group Lifestyle Intervention for People With New Onset Type 2 Diabetes.

Summary: The purpose of the study is to assess whether weight loss achieved through a programme of intensive lifestyle management can result in enhanced production of Glucagon-Like Peptide-1 (GLP-1) together with improvements in the release of insulin and glucagon and thus improvements in glycaemic control (HbA1c), in patients with new onset type 2 diabetes.~This is a cohort study with comparisons made between assessments at baseline, after an initial four months of intensive intervention and after a further four months follow up (maintenance period). Each patient will participate in the study for 8 month. The entire study period will be 24 months.~All patients with new onset type 2 diabetes (within 2 weeks of diagnosis) will be recruited from those referred to the Type 2 Diabetes Education Programme in the community (FOCUS), as per standard practice. The investigators will also hope to recruit direct from local GP surgeries who will be advised of the study. At this point, patients will be given a study information sheet with a contact number if they wish to participate in the study.~Individuals who are unable to give consent, who would be unable to attend all the programme sessions for medical or other reasons, who are prescribed oral hypoglycaemic, antiobesity or any other prescription medications that may interfere with the study results or whose BMI is < 25, will be excluded. The investigators will also exclude those who cannot converse competently in English as special arrangements would need to be made for such people attending the programme and this would be impractical in a group setting.~Those willing to participate will be invited for an individual appointment with the dietitian, during which the study structure, aims and procedures will be explained and consent to participate in the study will be obtained. For the first session of the programme, participants will be asked to attend following an overnight fast. Blood samples will be taken for basal measurement of glucose, HbA1c, lipids, insulin, glucagon, GLP-1, leptin, ghrelin and adiponectin. They will then be given a standard 75 g glucose load and sampling repeated at 30 mins (for peak GLP-1 levels). Baseline measurements of weight, height, percent body fat, waistline circumference and blood pressure will also be taken during this session. Following the assessment, patients will participate in the first session of the education programme. The full assessment will be repeated at 4 and 8 months intervals.~The weight management programme will be run by the Specialist Dietitian. It will consist of 2 phases: an initial 4 month intensive weight loss phase, followed by a 4 month weight loss / maintenance phase. The initial four month programme will consist of 8 group education sessions and at least 3 phone calls. The following 4 month programme will consist of 5 group sessions, at least 3 phone calls and 1 individual appointment. Each education session will last 60min. Before the 1st session and, at 4 month and 8 month sessions, bloods will be taken, as above. Before the rest of the sessions, there will be 15 minutes devoted to weight assessment. The programme will be based on portion control and healthy eating and will be supported by behavioural and cognitive change interventions. Such interventions will include self monitoring, stimulus control, goal setting, problem solving and relapse prevention. The specialists from Bournemouth HealthLink (a partnership backed by the local NHS, Council and University) will take part in helping participants to increase their activity levels.~The aim is to achieve weight loss of 5% over the first 4 months with, as a minimum, weight maintenance or possible further reduction over the subsequent four months.
Inclusion criteria: inclusion criteria:

 New onset of Type 2 Diabetes.

 BMI>25kg/m2

Exclusion criteria: :

 Antiobesity, oral hypoglycaemic medications or any other prescription medications that may interfere with the study results

 Pregnancy

 Unable to converse competently in English as special arrangements would need to be made for such people and this would be impractical in a group setting

 Attending another weight management programme

 Patients who would be unable to attend all the programme sessions for medical or other reasons

 Any patients from groups listed in A24


Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism

Summary: The objective of this retrospective study is to gather information about how fondaparinux is used pre-, peri- and/or postpartum for both the prophylaxis and treatment of venous thromboembolism (VTE) in order to fill an information gap concerning the off-label use of fondaparinux during pregnancy.
Inclusion criteria: inclusion criteria:

 Patients who were treated with fondaparinux pre-, peri- and/or postpartum for more than 7 days for VTE prophylaxis or treatment, especially those with a history of abortion, and/or stillbirth, VTE, severe fetal and maternal complications during pregnancy, severe inherited or acquired thrombophilias, long-term anticoagulation (e. g. patients with mechanical heart valves) and/or intolerance to heparins or heparinoids or heparin-induced thrombocytopenia (HIT)

Exclusion criteria: :

 Patients who were treated with fondaparinux for less than 7 days

 Patient who were treated with fondaparinux only postpartum


Randomized Evaluation of Default Access to Palliative Services

Summary: This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system. To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.
Inclusion criteria: inclusion criteria:

 Age 65 years or older

 Current hospitalization of at least 3 calendar days (modified ITT)

 Diagnosis of one or more of the following:

 End-stage renal disease (ESRD) on dialysis

 Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months

 Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months

Exclusion criteria: :

 1. Patients younger than 65 years old will not receive the intervention

['Default ordering of palliative consult']


Chest Physiotherapy in Pediatrics Patients With Pneumonia

Summary: Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.
Inclusion criteria: inclusion criteria:

 Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours)

Exclusion criteria: :

 Severely ill patients (hospitalized in intensive care units)

 Pleural effusion treated with chest drainage

 Atelectasis detected by x-ray

 Pneumonia or pleural effusion in the previous six months

 Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency

['Physiotherapy', 'Positioning and cough']


Developmental Trajectory of Brain Structural Connectivity and Cognitive Function From Childhood to Adulthood

Summary: Magnetic resonance imaging (MRI) is a premier modality to investigate structures and functions of human brain. In studies of children and adolescents, noninvasiveness of MRI makes it especially applicable. Developmental trajectory of gray matter volume and cortical thickness has been well studied in western countries. However, significant variability of brain structure has been reported between Chinese and Caucasian, and the variation may also exist in developmental trajectory of the brain. However, the maturation processes of neural fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has been frequently used to investigate the integrity of fibertracts in the literature, is limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly developed technique to improve the resolution of crossing fibers, and it is more suitable for detailed tractography assessment. In addition to establishing the template of brain structure (T1 and T2) and structural connectivity of our child, adolescent, and young adult population, the study has the following three aims.~To describe gender effect and developmental change of brain volume of different cortical and subcortical regions, thickness of cortex brain, and structural connectivity (e.g., frono-striatal, fronto-pareital, fronto-temporal and fronto-cerebeller tracts and superior longitudinal fasciculus II) across childhood through adolescent to adulthood;~To examine the gender effects and developmental change of attention, executive function and visual memory from childhood to adulthood and whether gender moderates these developmental changes; and~To correlate the structural connectivity and brain size and neuropsychological function within the same subjects.
Inclusion criteria: inclusion criteria:

 Ages 8-21 without current and past history of any psychiatric disorder and autistic symptoms.

Exclusion criteria: :

 Current symptoms or lifetime history of DSM-IV-TR diagnosis of attention-deficit/hyperactivity disorder, pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, bipolar disorder, depression, severe anxiety disorders or substance use.

 With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy.

 With major systemic disease.

 Full-scale IQ < 80.

['Brain Structural Connectivity', 'Cognitive Function']

Brain Structural Connectivity
Cognitive Function


School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence

Summary: The goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers. With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.
Inclusion criteria: inclusion criteria (all 4 criteria must be met):

 Physician-diagnosed asthma (based on parent report).

 Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:

 An average of >2 days per week with asthma symptoms

 >2 days per week with rescue medication use

 >2 days per month with nighttime symptoms

 ≥2 episodes of asthma during the past year that have required systemic corticosteroids

 Age ≥3 and ≤10 years.

 Attending school in participating Rochester City School District preschools or elementary schools.

Exclusion criteria: :

 Inability to speak and understand English. (*Parents unable to read will be eligible, and all instruments will be given verbally.)

 No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number).

 Family planning to leave the school district within fewer than 6 months.

 The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.

 Children in foster care or other situations in which consent cannot be obtained from a guardian.


Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma

Summary: HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few studies have been published on the use of HCIP in peritoneal carcinosis from ovarian background but most of them were non-randomized phase II studies on a small population using different type of drugs and dosage. before this heterogeneity it seems necessary to standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian background
Inclusion criteria: inclusion criteria:

 Stage IIIC unresectable ovarian, tubes or peritoneal primitive adenocarcinoma according to FIGO classification previously treated with 6 cycles of carboplatin-cisplatin neoadjuvant chemotherapy with a response allowing complete surgery after the 6 cycles

 Time frame between the sixth platin injection and the CRS + HCIP < 10 weeks

 No disease progression during the neoadjuvant chemotherapy

 18 </= âge </= 65 ans

 Performance Status OMS < 2

 Hematological function : PNN >/= 1.5x10^9/L, platelets >/= 150x10^9/L, hemoglobin > 9 g /dl (transfusion allowed)

 Hepatic function : Bilirubin </= 1,5 x LSN, ASAT (SGOT) and ALAT (SGPT) </= 3 x LSN, Phosphatases alkaline </= 3 x LSN

 No kidney related pathology, plasmatic creatinine < 140 µmol/l, creatinine clearance > 60 ml/min (Cockcroft formula) and urinary strip <2 (If urinary strip >/= 2, proteinuria < 1g/24h)

 Plasmatic albumine > 25 g/l

 HIV negative status

 Affiliation to social security

 Signed informed consent

Exclusion criteria: :

 Incomplete cell kill surgery

 Non-epithelial ovarian cancer

 Borderline tumors

 Non in complete remission previous cancer for more than 5 five years before inclusion

 Uncontrolled high blood pressure (blood pressure > 150/100 mm Hg despite antihypertensive treatment)

 Previous abdominal or pelvic radiotherapy

 Previous pathology of the central nervous system, except for well controlled pathology like epilepsy

 Previous stroke, transient ischemic attacks or subarachnoid hemorrhage

 Previous pulmonary embolism

 Pregnant or breastfeeding women (Women in age must have a blood negative pregnancy test at least 15 days before going under surgery)

 Participation to an other clinical trial within 30 days before inclusion in the study

 Known hypersensitivity to platin or bevacizumab

 Not healed wound, ulcer or bone fracture

 Previous haemorrhagic or thrombotic malfunction < 6 months

 Significant CArdiovascular disorder including:

 Heart attack or unstable angina within the 6 months before inclusion

 Grade > 1 congestive heart failure according to the NYHA classification

 Uncontrolled cardiac arrhythmia despite of treatment (patients with atrial fibrillation for which the pace is under control can be include)

 Long term or recent (within 10 days before inclusion) medication using Aspirin at dosage > 325 mg/day

 Long term or recent (within 10 days before inclusion) medication using anticoagulant per os or parenteral or thrombolytic given at full dosage for therapeutic purpose.

 Grade > 1 previous sensory and motor neuropathies according to CTC AE V4.0

 Previous abdominal fistula, GI perforation or intra-abdominal abscess within 6 months before first administration of bevacizumab

 Proof of any other disease, metabolic malfunction, physical or laboratory exam showing any possibility of disease or condition contraindicating administration of the drug under trial or exsposing the patient to several complications related to the treatment.

 Persons deprived of liberty

 Impossibility to comply with the medical following of the treatment for geographical, social or mental reason

['Ovarian Adenocarcinoma', 'Fallopian Tube Adenocarcinoma', 'Primary Peritoneal Carcinoma']

Ovarian Adenocarcinoma
Fallopian Tube Adenocarcinoma
Primary Peritoneal Carcinoma


Microparticles and the Risk of Re-stenosis Following Balloon Angioplasty in Patients With Peripheral Arterial Disease

Summary: Although microparticles have been well-documented as mediators of inflammation and coagulation in various cardio-vascular disease events, it is currently not known how Percutaneous Transluminal Angioplasty (PTA) for peripheral arterial disease influences microparticle numbers, phenotype and distribution pre- and post interventionally and how they are related to or affect the incidence of early re-stenosis - or if indeed they may be used to predict patients at risk of early re-stenosis.
Inclusion criteria: inclusion criteria:

 male or female

 60-85 years

 femoro-popliteal stenosis

 TASC B or C category

 HBA1c <9%, if diabetic

 creatinine <130µg/ml

 blood pressure <160/95mmHg

 thrombocyte aggregation inhibitors or coumarine derivatives

Exclusion criteria:

 <60 or >85 years

 stenosis not in femoro-popliteal axis

 TASC A or D category

 HBA1c >9%, if diabetic

 creatinine >130µg/ml

 blood pressure >160/95mmHg

 major trauma

 malignancy

 anti-phospholipid syndrome

 relevant hepatic disease

 major operation within 1 month of enrolment

['percutaneous transluminal angioplasty femoro-popliteal']


Biomarkers to Classify Heart Failure

Summary: The purpose of this study is to evaluate existing biomarkers and see if they can be used to accurately diagnose the etiology of heart failure.
Inclusion criteria: inclusion criteria:

 Patients admitted with symptomatic heart failure, diagnosed within 2 years.

 Diagnosis of congestive heart failure using the modified Framingham criteria:

 Simultaneous presence of at least 2 major criteria or 1 major criterion in conjunction with 2 minor criteria or a previous clear diagnosis of heart failure.

 Major criteria:

 Paroxysmal nocturnal dyspnea or orthopnea

 Neck vein distention

 Rales/Crackles (>10 cm from base of lungs)

 Acute pulmonary edema

 S3 gallop

 Increased central venous pressure (>16 cm H2O at right atrium)

 Hepatojugular reflux

 Weight loss >4.5 kg in 5 days in response to treatment Echocardiographic left ventricular dysfunction

 Minor criteria:

 Bilateral ankle edema

 Nocturnal cough

 Dyspnea on exertion

 Hepatomegaly

 Pleural effusion

 Weight loss >4.5 kg caused by heart failure where factors other than treatment of CHF could have contributed to the weight loss

 Tachycardia (heart rate >120 beats/min) Minor criteria are acceptable only if they cannot be attributed to another medical condition (such as pulmonary hypertension, chronic lung disease, cirrhosis, ascites, or the nephrotic syndrome).

Exclusion criteria: :

 Patients unable to provide blood sample

 Patients unable to provide consent

 Patient with life expectancy of less than 6 months, or has major co-morbidities.

 Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

 Participants who have participated in another research trial involving an investigational product in the past 30 days.


A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management

Summary: Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.~Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?~Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.~Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.
Inclusion criteria: inclusion criteria:

 patients with diagnosed COPD via the medical records with code J44

Exclusion criteria: :

 terminal illness

 cognitive impairments

['Chronic Obstructive Pulmonary Disease (COPD)']


Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis

Summary: Although stress ulcer is a complication that can cause significant mortality and morbidity in critical patients with risk factors, there is still lack of consensus about its prophylaxis. There are also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less association with nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Pantoprazole (iv) is the first intravenous form of proton pump inhibitor that was approved by FDA. There are some reports about its application for treatment of peptic ulcer bleeding. It also has good acid suppression effect in patients under critical care. We expect that intravenous pantoprazole will have a role in stress ulcer prophylaxis.~We will enroll those patients that have received major abdominal surgery and admitted to surgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days within 24 hours. They are randomly allocated to 2 groups. Group I: pantoprazole 40 mg iv bolus stat and then qd ; Group II: famotidine 20 mg iv bolus stat and then q12h. We will monitor the following data: operation type & time, APACHE II score, CBC, CXR, stool character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopic examination will be performed. We define the end point as overt bleeding, death or transfer out of ICU. We will compare the prevalence of UGI bleeding and ventilator associated pneumonia in these 2 groups
Inclusion criteria: inclusion criteria:

 those recieved major abdominal surgery (estimated admission to sirgical ICU more than 7 days); give written consent and was randomized within 24 hours of admission

Exclusion criteria: :

 age less than 18 y/o; pregnant; allergy to famotidine or pantoprazole; have had GI bleeding

['pantoprazole 40 mg iv', 'famotidine 20 mg iv']

pantoprazole 40 mg iv
famotidine 20 mg iv


Chloroquine and Post Malaria Anaemia Study

Summary: The pathogenesis of post-malaria anaemia is multifactorial. Iron supplementation remains the mainstay of management of moderate and severe anaemia; however the management of mild anaemia (Hb 80-110g/l) is problematic as population supplementation studies of children in malaria endemic areas demonstrate adverse effects in children with mild anaemia. We hypothesize that the anti-inflammatory, anti-malarial and anti-macrophageal iron loading effects of chloroquine could make it a useful drug in the management of mild post malaria anaemia. To test this hypothesis, we plan to randomize children (aged 12 months to 6 years) with post malaria anaemia (Hb 70-110g/l) to receive a standard anti-malarial treatment, co-artemether . All children with parasitologic cure after three days on treatment will be randomised to receive either weekly chloroquine or weekly placebo starting from day 10 till day 90. By comparing the curve of haemoglobin change between day 3 and day 30 in the placebo arms of the two groups, we will test the effect of chloroquine vs. ACT treatment on macrophageal iron loading and release in acute clinical malaria. By comparing the haemoglobin change between day 3 and day 90 between the weekly chloroquine arms and the weekly placebo arms we will test the longer-term anti-inflammatory and anti- malarial effects of weekly chloroquine prophylaxis. In addition to the primary endpoint, we plan to assess potential mechanisms of action by determining parasite clearance, peripheral cytokine production and iron flux
Inclusion criteria: inclusion criteria:

 All children aged 12 months to 6 years in the 13 study villages will be enrolled in the study and followed up for the duration of the study. The inclusion criteria for randomization will be:

 Children aged 12 months to 6 years; and

 History of fever in the preceding 48 hours or a measured temperature > 37.5oC plus asexual forms of P. falciparum in the peripheral blood film of 500/μl or above; and

 Hb <110g/l and >69g/l (Our choice of the upper limit of moderate anaemia (70 - 79g/l) is to enable us assess the response to our interventions of severer forms of anaemia while at the same time reducing the risk of adverse events which might occur with lower levels of Hb).

Exclusion criteria: :

 Refusal of parent or guardian to give consent to the child's participation in the study

 Inability of the subjects to take oral medications

 Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density

 Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia & gallop rhythm, tender hepatomegaly

 Children with known haemoglobinopathy

 Children with a weight for height Z score below -3SD of WHO/NCHS standard

 Enrolment in another research project


Aspiration Treatment of Perianal Abscess

Summary: The purpose of this study is to compare aspiration and oral antibiotics with surgical incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula formation. Included patients will be randomised to either aspiration or incision.
Inclusion criteria: inclusion criteria:

 ≥18 yrs old

 Perianal abscess (without spontaneous rupture)

 Abscess larger than 2 cm in diameter

 Signed informed consent

Exclusion criteria: :

 Malignancy within 5 yrs

 Previous radiotherapy of the abdomen and pelvis

 Recurrent abscess within 6 months

 Immune suppressed patients

 Pregnant and lactating women

 Abscess with horseshoe formation

 Allergy to Clindamycin

['MEDIPLAST® (aspiration)', 'incision', 'Clindamycin']

MEDIPLAST® (aspiration)
incision
Clindamycin


Clinical IGSP-CHOP Boston

Summary: The main purpose of this study is to look at relationships between types of flu viruses and characteristics of infected patients, including vaccination status, organ system involvement, and disease severity. In this study, 500 patients with respiratory illnesses will have nose/throat fluid samples collected. At Children's Hospital Boston, patients 30 days to 5 years of age will be recruited; at Beth Israel Deaconess Medical Center, patients of any age will be eligible. The researchers will compare the symptoms of infection by similar flu virus types and look at differences in the flu virus types between the 2 age groups of patients. The researchers will also look at whether any flu virus types first show up in the children prior to infecting the adults. Hopefully this study will improve understanding of how flu viruses develop, spread, and cause disease. This information may help the development of more effective flu vaccines, prevention measures, and treatments.
Inclusion criteria: inclusion criteria:

 For pediatric population: Age of patient: 30 days - 5 years; for adult population: any age

 Illness onset within past 5 days

 Symptoms of fever (>=38°) plus one or more of the following: cough, runny nose, congestion, or sneezing (twice or more within one day). These symptoms must be present at the time of presentation to the emergency department (ED) or admission to the hospital.

 Patient or parent/guardian is able to give informed consent

Exclusion criteria: :

 Pediatric patient or non-verbal adult is not accompanied by a caregiver

 Participant/caregiver cannot be reached by phone in 7-10 days

 Patient has a condition that can compromise respiratory function or the handling of respiratory secretions (e.g., severe cognitive dysfunction, spinal cord injuries, or other neuromuscular disorders)


Changes After Angiotensin Converting Enzyme (ACE) Inhibitor Replacement by Angiotensin II Receptor Type I (AT1) Blocker

Summary: It is supposed that the significant metabolic effects (improvement of insulin sensitivity) of hypertension therapy with renin-angiotensin system (RAS) blockers in humans are mediated mainly via changes in abdominal adipose tissue. This project is aimed to confirm the hypothesis that increased concentrations of circulatory angiotensin II after angiotensin II receptor type I (AT1) blockade leads, via stimulation of angiotensin II receptor type II (AT2), to activation of adipogenesis and improvement of insulin sensitivity. Therefore, in hypertensive patients, the components of RAS and the parameters of insulin sensitivity on systemic (in plasma) and local (in adipose tissue and in its interstitial fluid) level will be studied. The main aim of the study is to identify the changes occurring in patient before and 6 months after the conversion of therapy from angiotensin converting enzyme (ACE) inhibitors to AT1 receptor blockers. Observed parameters will include gene expression of RAS components, parameters of insulin sensitivity, amount, and cellularity of adipose tissue obtained by biopsy, evaluation of direct production of cytokines and angiotensins into the interstitial fluid of fat tissue obtained by microdialysis and evaluation of the selected parameters in plasma.
Inclusion criteria: inclusion criteria:

 essential hypertension

 ACE inhibitors

Exclusion criteria: :

 diabetes mellitus

 endocrinopathies

 no smokers


Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

Summary: The open abdomen is a valid and accepted surgical tactic for the trauma and acute care patient. There have been many mechanisms described for its management, but the most accepted strategy is the vacuum pack. At our hospital the investigators have used for many years a double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation. At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the investigators try to tighten the mesh with sutures until the abdomen can be closed. This study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to determine which is related to a higher fascial closure rate.
Inclusion criteria: inclusion criteria:

 Open Abdomen

Exclusion criteria: :

 Patients that die in the first 48 hours after the initial intervention

['Vacuum Pack', 'Double Sylo Bag - Mesh Protocol']

Vacuum Pack
Double Sylo Bag - Mesh Protocol

['Open Abdomen', 'Temporary Abdominal Closure Mechanisms']

Open Abdomen
Temporary Abdominal Closure Mechanisms


Extended Clomiphene Citrate Regimen in Women With Polycystic Ovary Syndrome

Summary: One hundred and thirty six anovulatory women with CC-resistant PCOS were scheduled randomly into two equal groups. Group A (n=68); received CC (100 mg/day from cycle day 3 for 10 days) for up to six cycles. Group B (n=68) underwent LOD and followed up for 6 months. The primary outcome was the ovulation rate in each group; secondary outcomes were midcycle endometrial thickness and serum estradiol, midluteal serum progesterone, and the rates of clinical pregnancy and abortion.
Inclusion criteria: inclusion criteria:

 Age: between 18-35 years

 Period of infertility > 2 years

 Serum level of FSH <10 U/L in the early follicular phase

 All women were CC-resistant PCOS, as they failed to ovulate with a dose of CC of 150 mg/day for 5 days per cycle for at least three consecutive cycles

 All women had patent Fallopian tubes proved by hysterosalpingography or laparoscopy and their partners satisfied the normal parameters of semen analysis according to the modified WHO criteria

Exclusion criteria: :

 Infertility due to causes other than CC- resistant PCOS or due to combined factors

 Body mass index (BMI) ≥35 Kg/m²

 The use of metformin, gonadotropins, hormonal contraception or diet regimen within the last 6 months

 Women with congenital adrenal hyperplasia, hyperprolactinaemia or abnormal thyroid function

 Hypersensitivity or contraindications to Letrozole or clomiphene treatment

 Previous LOD

['clomiphene citrate', 'laparoscopic ovarian drilling (LOD)']

clomiphene citrate
laparoscopic ovarian drilling (LOD)


Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder

Summary: The primary objective is to examine changes in pre/post-augmentation healthcare costs and resource utilization in patients diagnosed with major depressive disorder (MDD) who augment their current antidepressant therapy with an atypical antipsychotic.
Inclusion criteria: inclusion criteria:

 Patients who meet the following criteria will be included in the study:

 aged 18 to 64 years

 diagnosis of major depressive disorder during the study timeframe (ICD 9 codes 296.2, 296.3, 311)

 evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)

 must be continually enrolled during the study timeframe and have both medical and pharmacy benefits

 evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)

 evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic

 After at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months.

Exclusion criteria: :

 Patients are excluded if they:

 have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period

 have Electroconvulsive therapy (ECT) during the study period

 new augmentation with mood stabilizers, L-thyroxine (T4), L-Thyronine (T3), buspirone, stimulant, or others during the post-period (table 1)

 are pregnant during the study period

 patients with Medicare or Medicaid


Dementia Early Recognition and Response in Primary Care

Summary: The purpose of this study is to develop and test an educational intervention for dementia in primary care, combining timely diagnosis, psychosocial support around the period of diagnosis and management concordant with guidelines.
Inclusion criteria: inclusion criteria:

 Patients with memory or other cognitive impairments suggestive of dementia syndrome

 those with a formal diagnosis of dementia, of any type.

Exclusion criteria: :

 Patients and carers who are already involved in concurrent research

 If the key professional feels that an approach to the person with dementia or their carer would be inappropriate, for example the dementia is very severe, or that an approach may increase distress

 and any other important reason that the key professional may have for why the person with dementia or their carer should not be contacted.


Levothyroxine Treatment for Subclinical Hypothyroidism After Head and Neck Surgery

Summary: Patients that require treatment for cancers of the head and neck often require a combination of surgery and/or radiation and chemotherapy. Hypothyroidism is one of the most common complications, and has been associated with post-operative complications such as wound healing problems, fistula formation, and decreased quality of life and survival. Several studies have examined hypothyroidism after radiation to the head and neck, but few have examined this after non-thyroid head and neck surgery. Head and neck resection is theorized to devascularize the thyroid, thus resulting in post-operative hypothyroidism.~Synthroid is a synthetic thyroid hormone often used in cases of patients with proven hypothyroidism and after surgical thyroid removal. It's use has been in effect and studied for over fifty years.~Treatment algorithms for hypothyroidism are well published. However, treatment of subclinical hypothyroidism (elevated TSH with normal or near-normal T3/T4) is controversial. The rate of subclinical hypothyroidism after non-thyroid head and neck surgery is high (up to 20%), and is associated with post-operative complications as noted above.~Therefore the investigators propose a double blinded randomized controlled trial comparing outcomes of patients that develop subclinical hypothyroidism after head and neck surgery, who are given a standardized dose of synthroid treatment versus those treated with placebo. The main outcomes to be examined are post-operative complications (wound healing issues, fistula formation), survival, and quality of life measures.
Inclusion criteria: inclusion criteria:

 Biopsy proven head and neck cancer, as defined by AJCC staging system

 Treated with surgery in Edmonton, Alberta

 Treated with curative intent

 Diagnosis of sub-clinical hypothyroidism after head and neck surgery (TSH 4-10mIU/L, and free T4 10-24pmol/L)

Exclusion criteria: :

 Head and neck cancer of the thyroid gland, or other subsite involving the thyroid gland

 Underwent previous treatment for a different head and neck cancer

 History of radiation therapy and or chemotherapy to the head and neck

 History of thyroid disease as follows:

 Hypothyroidism

 Hyperthyroidism

 Autoimmune thyroid disease including Grave's disease and Hashimoto's thyroiditis

 History of thyroiditis

 History of diabetes mellitus

 History of long term steroid usage

 History of immunocompromise

 History of thyroid surgery

 History of ischemic heart disease

 Age >80

 Patients taking a medication that may alter the metabolism or interact with levothyroxine, which they cannot safely stop (see Appendix A).

['Hypothyroidism', 'Neoplasms', 'Postoperative Complications']

Hypothyroidism
Neoplasms
Postoperative Complications


The Effect of Intravenous Lidocaine on Pain After Tonsillectomy

Summary: This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy.~A total of 62 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.~Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.~Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.
Inclusion criteria: inclusion criteria:

 Tonsillectomy

Exclusion criteria: :

 mental change

 allergy to local anesthetics

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

Intravenous lidocaine injection
Intravenous normal saline injection


Antithyroid Drug Treatment of Thyrotoxicosis in Young People

Summary: The investigators aim to establish whether biochemical control during anti-thyroid drug therapy in young people with thyrotoxicosis varies depending upon whether a 'block and replace' or 'dose titration' regimen is used. The investigators will also assess remission rates and the frequency of side-effects in the two treatment groups.
Inclusion criteria: inclusion criteria:

 All patients with thyrotoxicosis aged between 2 and 16 years at the time of diagnosis. Thyrotoxicosis will be diagnosed by the paediatrician on the basis of the clinical picture and the biochemistry (suppressed TSH with high thyroid hormone levels).

 Child has consented/assented or consent via parent/guardian has been gained prior to any study specific procedures

Exclusion criteria: :

 Known toxic adenoma / toxic hyperplasia (germline activating TSHR mutation).

 McCune Albright Syndrome.

 Previous episodes of Thyrotoxicosis..

 Known allergic response to any of the study medication or ingredients as per SmPC.

 Previous participation in this study.

['Block and Replace', 'Dose Titration', 'carbimazole', 'propylthiouracil', 'thyroxine']

Block and Replace
Dose Titration
carbimazole
propylthiouracil
thyroxine