Which One Should be Treated in the Setting of Acute ST Elevation Myocardial Infarction - Culprit Lesion or Culprit Vessel?

Summary: The current guidelines still recommend emergent PCI of the culprit lesion and state that primary PCI should be limited to the culprit vessel with the exception of cardiogenic shock and persistent ischaemia after PCI of the supposed culprit lesion. This recommendation is based on a high number of studies. However, several studies are present about the safety and efficacy of non-culprit vessel PCI during acute MI. Nowadays, the debate is increasingly going on about the PCI of the non-culprit arteries during the index event with newer prospective randomized studies. Besides, it is still unclear for the culprit artery whether to treat only the culprit lesion or all the other lesions in the culprit vessel during the index event. The present report describes a retrospective comparison between the two strategies during primary PCI for STEMI, looking for their influence on the clinical and angiographic course of the patients.
Inclusion criteria: inclusion criteria:

 Patients who underwent primary PCI for acute STEMI and had >1 lesion in the culprit artery

Exclusion criteria: :

 Presence of LMCA lesion

 Cardiogenic shock

 Previous CABG operation

 Decision for CABG operation after primary PCI

 Severe valvular disease including aortic stenosis of mitral insufficiency

 Severe kidney disease (serum creatinine >2.5 mg/dl or patients on maintenance hemodialysis)

 Rejection of second PCI by the patient after the index event


Bending Adolescent Depression Trajectories Through Personalized Prevention

Summary: Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better bend trajectories of depression that surge throughout adolescence.
Inclusion criteria: inclusion criteria:

 Currently in the 6th to 11th grades

 Adolescent and parent must be English-speaking

 Parental consent and adolescent consent

Exclusion criteria: :

 Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis

 Suicide attempt in the past week or significant suicidal ideation in the past week

 Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate

['Interpersonal Psychotherapy- Adolescent Skills Training', 'Coping with Stress']


Trial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants

Summary: The purpose of this study is to test the safety of a transfusion of specialized white cells from your transplant donor's blood, called T-cells, that have been grown and immunized against the CMV virus in the test tube. If the transplant donor is immune to CMV (ie: the donor has antibody to CMV in the blood), the T-cells will be selected and grown from the blood of the transplant donor. However, if the transplant donor is not immune to CMV, or if T-cells from the donor are not readily available, CMV-immune T-cells grown from the blood of another normal donor who is partially matched to the patients tissue type can be used. The transplant physician will explain which of these treatments is available to the patient.~This trial is called a phase I trial because phase I trials are designed to test the safety of different doses of an experimental treatment. We want to find out what effects, good and/or bad, a dose/doses of these immune T-cells will have on the patient and on the CMV infection.~Specifically, we wish to test CMV immune T-cells grown from your blood using a new method developed at our center. In this method, fragments of an important CMV protein, called CMVpp65, are chemically synthesized and then used to immunize T-cells in the test tube.
Inclusion criteria: inclusion criteria:

 Prior to receiving treatment, some patients may undergo diagnostic and/or other testing of their tissue, if available, to determine if their CMV infected cells are likely to respond to treatment with CMV specific T cells. Alternatively, blood samples may be required for research tests to ascertain that the CMV-specific T-cells do not contain any cells that could react against the patient. These patients will sign a separate pre-treatment consent. If it is determined that a patient will qualify for and might benefit from infusions of CMV CTLs, he/she will go on to sign the standard treatment consent for MSKCC IRB # 05-065 and be enrolled and treated on trial, if all other eligibility criteria are met.

 Each patient must satisfy at least one of the following criteria:

 The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis) or

 The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of CMV antigenemia or detection of levels of CMV DNA in blood or body fluids consistent with CMV infection.

 The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV antigenemia or CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs.

 The patient has developed CMV viremia as attested by viral culture, or detection of CMV antigenemia or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant. or

 the patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC < 1000 ul/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance < than or equal to 60ml/min/1.73m2 or creatinine >2 mg/dl]).

 Because CMV infections are life-threatening and may involve the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems, and antiviral drugs may also compromise renal and hematopoietic function, dysfunctions of these organs will not affect eligibility for this protocol.

 However, to be eligible, the patients should meet the following clinical criteria:

 They must have a stable blood pressure and circulation, not requiring pressor support.

 They should have adequate cardiac function as demonstrated by EKG and/or by echocardiographic evidence.

 They should have a life expectancy, even if they require respirator support, of at least 3 weeks.

 They are no age restrictions to eligibility for this protocol.

Exclusion criteria: :

 Patients requiring high doses of glucocorticosteroids (>0.5 mg/kg prednisone or its equivalent) as treatment for active (grade 2-4) acute graft vs. host disease (GVHD) or chronic GVHD.

 Patients who are moribund.

 Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T cell infusion.

 Donor Eligibility for Donation of Blood Lymphocytes for Generation of

 Donor-Derived CMV-Specific T cells:

 Adequate health for donation as determined by institutional (related donor) or NMDP (unrelated donor) guidelines. Normal donors will be evaluated for evidence of prior sensitization to CMV by CMV serology. They will also be typed for HLA A, B, C and DR. For allogeneic hematopoietic progenitor cell transplant (HSCT) recipients, the marrow transplant donor will constitute the donor of choice, since those T-cells will grow and persist in a patient who has already engrafted with a transplant from that donor. However, if the HSCT donor is CMV seronegative or not available (e.g. a cord blood transplant or an unrelated donor who has not already donated T-cells for adoptive therapy), CMV-specific T-cells generated from a seropositive donor matched for at least 2 HLA alleles shared by the patient may be used.

 Normal donors fulfilling these criteria who consent to donate blood for the generation of CMV-specific T-cells for adoptive therapeutic purposes will receive a detailed clinical evaluation, including a medical history, physical examination, and serologic testing for transmissible diseases within 1 week of donation including hepBs Ag and hepatitis C antibody, HIV-1 and 2, HTLV-1 and 2, CMV (only if previously negative), VDRL, WNV, and Chagas An HIV+ donor will be rejected on medical grounds. Donors must have Hgb value > 10 gm/dl and must be capable of undergoing a single 3-6 unit leukapheresis (preferable) or a single unit of blood for T cells (for pediatric donors, no more than 5 ml/kg at any one blood draw).

 A prospective donor will be informed of the purposes of this study, and its requirements. If he/she consents, the donor will be requested to provide two blood samples:

 i. An initial donation of 25ml blood anticoagulated with heparin or ACD. This blood is used to establish a B cell line transformed with the B95.8 laboratory strain of EBV. This EBV+ B cell line/ (EBVBLCL) will be used as an antigen-presenting cell. When loaded with the pool of CMVpp65 pentadecapeptides, the EBVBLCL efficiently sensitize T cells from the same donors against CMV as well as EBV.

 Because the establishment and testing of an EBV transformed B cell line suitable for use or as an antigen-presenting cell require 4-5 weeks of in vitro culture, it is important that this sample be obtained as early as possible for patients at risk for a CMV infection. Because patients receiving HSCT from unrelated or HLA disparate donors are particularly at risk for severe CMV infections in the first 2-3 months after transplant, this blood sample should be obtained from the donor prior to donation of the hematopoietic progenitor cell transplant whenever possible.

 ii. A donation of either a single standard 2 blood volume leukapheresis collected in standard ACD anticoagulant. If it is impossible to collect a leukapheresis from some of the donors, a unit of whole blood will be acceptable. However, the AICTF (Adoptive Immune Cell Therapy Facility manufacturing the clinical grade cell products under GMP conditions in MSKCC) may only be able to generate a limited number of T cells from a unit of blood. This blood is required for isolation of the T cells to be sensitized with the pool of CMVpp65 15-mers loaded on the autologous EBVBLCL, and propagated in vitro. In addition, it is required to provide autologous feeder cells essential to sustain T-cell growth without the risk of stimulating the growth of alloreactive T-cells capable of inducing GVHD.

 This donation of a leukapheresis or a unit of blood will be obtained from unrelated HSCT donors at least 2 weeks after their donation of an HSCT, or as soon as possible thereafter.

 In order to limit the number of blood or leukapheresis donations that would be required of any donor, each donor will be informed of the following potential applications of the blood cells donated. The white cells contained in one leukapheresis are sufficient to grow enough T- cells to treat the three conditions below in a transplant patient:

 The use of cells to generate CMV-specific T-cells for potential use in the treatment of the patient for whom the donor has provided an HSCT, under MSKCC IRB # 05-065.

 The use of a fraction of the cells isolated to generate:

 immune T-cells specific for another virus, such as Epstein-Barr virus, that can cause lethal lymphomas in transplant recipients, and

 immune T-cells specific for a protein called WT-1, that is differentially expressed by malignant blood cells.

 Such T-cells could be used, under separate protocols, to treat EBV associated diseases (IRB 95-024) and/or to treat or prevent leukemia recurrence (07-055) in the patient receiving the donor's hematopoietic progenitor cell transplant.

 The donation of the immune T-cells generated from the donor that are not used for or required by the patient for whom they were originally intended to a bank of immune cells that will be stored and maintained cryopreserved under GMP conditions in the Adoptive Immune Cell Therapy Facility at MSKCC, These stored T-cells , may be used for the treatment of other patients with CMV or EBV infections/malignancies that express HLA alleles shared by the donor.

 In addition to these prospectively accrued donors, we have, since the initiation of this protocol, generated over 100 CMV-specific T-cells for patients at high risk for infection, of which far fewer patients have required treatment. Since these patients are now beyond the period of risk for CMV infection, their donors will be approached with a separate consent to allow for the use of their T cells in recipients other than the primary patients for whom they initially donated cells.


Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

Summary: In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.
Inclusion criteria: SELECTION OF PATIENTS (MOST IMPORTANT CRITERIA)

 inclusion criteria for first-line therapy

 • Histologically confirmed breast cancer with distant metastases

 Note:

 A biopsy from the primary tumor or a metastasis can be used for diagnosis.

 Patients with non-measurable lesions are eligible.

 Patients with inoperable, locally advanced breast cancer with lymph node metastases other than ipsilateral locoregional (axillary, infraclavicular, parasternal) or other distant metastases are eligible.

 Patients with bone metastases with or without bone targeted therapy (bisphosphonates, denosumab) are eligible.

 Patients with de-novo Stage IV disease are eligible.

 HER2-positive tumor according to central pathology testing for HER2

 Note:

 A formalin-fixed paraffin-embedded (FFPE) biopsy from the primary tumor or a metastasis has to be used for HER2 status determination. If a biopsy is available from a metastasis, the HER2 testing should be performed using the metastasis.

 Fine needle aspiration is not acceptable for HER 2 testing. • Women aged ≥18 years

 • WHO performance status 0 to 2

 Left Ventricular Ejection Fraction (LVEF) ≥50% as determined by either ECHO or MUGA

 Adequate organ function, evidenced by the following laboratory results:

 Neutrophils >1.5x109/L, platelets >100x109/L, hemoglobin ≥90g/L, total bilirubin ≤1.5xULN (unless the patients has documented Gilbert's disease), AST ≤3xULN, ALT ≤3xULN, AP ≤2.5xULN (except in patients with bone metastases: AP ≤5xULN), creatinine ≤1.5xULN

Exclusion criteria:  for first-line therapy

 • Prior chemotherapy for inoperable locally advanced or metastatic breast cancer

 Note:

 Prior neoadjuvant/adjuvant chemotherapy is allowed if doses for anthracyclines have not exceeded 720mg/m2 and 240mg/m2 for epirubicin and doxorubicin, respectively.

 - Re-exposure to paclitaxel is permitted, if the last dose of taxane was given at least 1 year before randomization.

 - Re-exposure to vinorelbine is permitted, if the last dose of vinorelbine was given at least 1 year before randomization.

 Prior anti-HER2 treatment for metastatic or inoperable breast cancer

 Note:

 Prior neoadjuvant/adjuvant anti-HER2 treatment with trastuzumab and/or lapatinib is allowed.

 • More than one endocrine treatment line for metastatic or inoperable breast cancer exceeding a duration of 1 month

 Note:

 Adjuvant endocrine treatment is not counted as one line.

 Patients progressing on endocrine treatment: this specific endocrine treatment must have been stopped at least 2 weeks prior to randomization.

 • Prior treatment with pertuzumab and/or T-DM1

 • Known leptomeningeal or CNS metastases

 Note:

 A brain MRI or CT scan is mandatory in case of clinical suspicion of CNS metastases.

 • Single bone metastasis treated with radiotherapy (if the bone metastasis is the only tumor lesion)

 inclusion criteria for second-line therapy • At least one dose of trial therapy in the first-line treatment phase of this trial

 • • Proven disease progression on first-line therapy or radiotherapy of a bone metastasis

 Notes:

 First new parenchymal CNS metastases only do not count as progression requiring the initiation of second line trial treatment. Radiotherapy of a single area only for pain control is allowed and will not count as PD.

 • Adequate organ function, evidenced by the following laboratory results: Neutrophils >1.5x109/L, platelets >100x109/L, hemoglobin ≥90g/L, total bilirubin ≤1.5xULN (unless the patients has documented Gilbert's disease), AST ≤3xULN, AP ≤2.5xULN (except in patients with bone metastases: AP ≤5xULN), creatinine ≤1.5ULN

 • LVEF ≥50% as determined by either ECHO or MUGA

 • QoL questionnaire has been completed.

['Trastuzumab', 'Pertuzumab', 'Paclitaxel', 'Vinorelbine', 'T-DM1']

Trastuzumab Pertuzumab Paclitaxel Vinorelbine T-DM1


Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux

Summary: Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx, is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation. The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high placebo effect can be observed. Sodium Alginate is an effective medication indicated for symptomatic treatment of gastroesophageal reflux. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety profile of sodium alginates oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with LPR patients in Taiwan. Efficacy assessments include mean reduction in the total reflux symptom index (RSI) score after 4 and 8 weeks treatment, mean reduction in the total reflux finding score (RFS) after 4 and 8 weeks treatment, mean changes in the total numbers of reflux episodes as measured by 24-hour ambulatory combined impedance-pH monitoring after 1 day and 8 weeks treatment. Safety assessments include incidence of adverse events. The study hypothesis is sodium alginate is superior over placebo in relieving LPR symptoms.
Inclusion criteria: inclusion criteria:

 Patients with age of 12-75 years old (inclusive)

 Patients with at least one symptom consistent with LPR, including hoarseness, throat clearing, throat pain, globus sensation in the throat, or chronic cough ≧ 4 weeks before entering study

 Patients with a total reflux symptom index (RSI) >10 (based on a self-administered 9-item questionnaire of voice/throat complaints)

 Patients with a total reflux finding score (RFS) >5 (based on a laryngoscopic examination by investigators)

 Patients or their legal representatives have signed the informed consent form

Exclusion criteria: :

 Patients with viral or bacterial laryngitis, or occupational exposures causing laryngitis

 Patients with erosive GERD as evidenced by upper GI endoscopy

 Patients with laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, , or with history of neck radiation therapy

 Patients with history of uncontrolled hypertension or moderate to severe renal impairment

 Patients with history of esophageal or gastric surgery

 Patients with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray

 Patients with endotracheal tube intubation within 2 months before entering study

 Patients had taken any alginate preparations within 2 days; H2-blocker, prokinetic agent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days before screening

 Patients with a history of allergy to the study drugs or their related compounds

 Patients with a history of alcohol or drug abuse, or with any psychiatric disease

 Patients participated any investigational drug trial within 4 weeks before entering the study

 Patients with any other conditions or diseases that investigator considers it is not appropriate to enter the study


Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus

Summary: The purpose of this study is to reveal the key proteins involved in gastric bypassing surgery which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes mellitus patients in China.
Inclusion criteria: inclusion criteria:

 patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass

 age:18-65yr

 HbAlc>8%

Exclusion criteria: :

 diabetes (applies for control patients)

 chronic inflammatory disease

 malignant disease

 pregnancy

 prior gastric, duodenal, proximal jejunal surgery or pancreas resection

 current use of thiazolidinediones

 treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months

 HbAlc<8%

 any condition felt by the investigator to interfere with ability to complete the study


A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting

Summary: The purpose of this investigator-initiated study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood surgery level. The reason for this study is that IV dextrose has been shown to decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction.
Inclusion criteria: inclusion criteria:

 ASA I or II

 female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital

Exclusion criteria: :

 age <18 or >65;

 severe hypertension,diabetes mellitus, significant hepatic or renal disease

 excessive blood loss

 sustained (>10 min)>20% from baseline drop in BP after treatment

 inability to follow protocol

 refusal to sign consent

['Intravenous fluid', 'D5LR or lactated ringers']

Intravenous fluid
D5LR or lactated ringers


A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases

Summary: This study examines surgery versus radiosurgery (highly focussed radiation) for the treatment of cancer which has spread to one spot in the brain (solitary brain metastasis). For these two treatment options, it will compare patients' survival times, quality of life, control rate of the brain metastases and side effects. It uses the most rigorous scientific method available called randomisation which minimises biases that exist with other types of studies. It will involve 30 - 40 patients.
Inclusion criteria: inclusion criteria:

 Single presumed brain metastasis on contrast magnetic resonance imaging (MRI) scan within two weeks before commencement of treatment.

 Systemic cancer diagnosed histologically or cytologically synchronous with, or within 5 years of treatment of the presumed brain metastasis (other than non-melanoma skin cancer and cancer in-situ of the cervix, neither of which would be reasonably attributable as the primary site). Exception - melanoma diagnosed > 5 years previously is allowable in view of the extremely variable natural history of melanoma.

 Age >= 18 (no upper age limit).

 Considered suitable for both S and RS by the neurosurgeon and radiation oncologist (see exclusions).

 Patient must agree to adjuvant WBRT.

 RTOG RPA Class 1 or 2 (Karnofsky Performance Status [KPS] >= 70 after adequate trial of corticosteroids).

 RPA Class 3 patients (KPS < 70) eligible if it is considered that the poor performance status is due primarily to the solitary metastasis, aggressive local treatment of which may be expected to restore good performance status. This would ordinarily be associated with minimal systemic disease burden.

 Accessible for treatment and follow-up.

 Patient is infertile or is aware of the risk of becoming pregnant or fathering children and will use adequate contraception.

 Written informed consent

Exclusion criteria: :

 Previous history of brain metastasis(es)

 Surgery indicated to relieve life-threatening raised intracranial pressure or excision required for tissue diagnosis (no extra-cranial site to biopsy ie unknown primary). However, prior diagnostic (non-excisional) biopsy is allowable - it is acknowledged that the 50% probability of a repeat surgical procedure on subsequent randomisation would not be acceptable to many patients and clinicians.

 Surgery contraindicated by site (e.g. thalamus, brain stem) or medical co-morbidities.

 Leptomeningeal disease.

 Primary is small cell lung cancer, germ cell tumour, lymphoma, leukaemia or myeloma.

 Prior cranial RT (including RS).

 Patient is pregnant.

['Surgery + WBRT', 'Radiosurgery + WBRT']

['Neoplasm Metastasis', 'Brain Neoplasm']


Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis

Summary: The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.
Inclusion criteria: Key inclusion criteria:

 Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.

 Multiple sclerosis (MS) onset within one year before enrolment

 ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.

 No previous disease modifying and/or immunosuppressive treatments for MS.

 Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion criteria: :

 Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)

 Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide

 Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates

 History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)

 History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.

 History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.

 History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.

 History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.

 An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.

 NOTE: Other protocol-defined inclusion/

['Relapsing Remitting Multiple Sclerosis']


Comparison of Biomarkers of Stress in Emergency Physicians Working a 24-hour Shift or a 14-hour Night Shift - the JOBSTRESS Randomized Trial

Summary: A stressful state can lead to symptoms of mental exhaustion, physical fatigue, medical errors, and also increase coronary heart disease. Emergency physicians subjectively complain of stress related to changes in work shifts. Several potential biomarkers of stress have been described, but never investigated in emergency physician, who may represent a good model of stress due to the complex interplay between stress (life-and-death emergencies, which is the defining characteristic of their job), lack of sleep and fatigue due to repeated changes in shifts.The aim of this study was to compare biomarkers in emergency physicians working a 24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day (clerical work on return from leave). We also followed these markers three days following each shift (D3/24hS and D3/14hS).
Inclusion criteria: inclusion criteria:

 emergency physician

Exclusion criteria: :

 endocrine disease, pregnancy, recent extraprofessional deleterious life event (such as death of a near relative, divorce), any current illness, drugs used to modulate inflammatory diseases (corticosteroids, anti-inflammatory drugs, immunomodulatory drugs), or any drugs with a chronotropic effect taken over the previous six months (beta blockers, diltiazem, verapamil, anxiolytics or antidepressants).

['Biomarkers of Stress in Emergency Physicians']

inclusion criteria:

 emergency physician


Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder Patients

Summary: The purpose of this study is to explore the effect of an inflammatory and a psychosocial stressor and the combination thereof on mood in healthy young and elderly participants and patients with Major Depressive Disorder (MDD).
Inclusion criteria: inclusion criteria:

 Has body mass index (BMI) [weight in kilograms / (height in meters x height in meters)] between 18 and 30 kg/m2

 For young healthy participants: female, 25 to 45 years of age; elderly healthy participants: female: ≥ 65 years of age & with baseline C-reactive protein (CRP) > 5 mg/mL; (partially) remitted MDD patients: female, 25 to 45 years of age

 inclusion criteria specific for patients with MDD: -Patients with a history (within 24 months) of MDD must have a Montgomery-Asberg Depression Rating Scale (MADRS) total score < 15 and symptom remission (temporary absence of disease symptoms) relative to the acute episode must have been present for at least 3 months

Exclusion criteria: :

 Has a current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I diagnosis (other than MDD)

 Has recently experienced a psychosocial stressor within 6 months

 Has acute symptoms of suicidality (the likelihood of an individual completing suicide)

 Has a DSM-IV diagnosis of substance abuse or dependence within 6 months prior to screening evaluation

 Has been exposed to an experimental medication or experimental medical device within 90 days before screening

 Has a serology (scientific study of blood serum and other bodily fluids) positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV antibodies at screening

 Has been exposed to typhoid or typhoid vaccine within 5 years before screening

 Has been prior exposed to the Trier Social Stress Test (TSST)

 Has received electroconvulsive therapy (shock therapy) within 3 months before screening

 Has been involuntarily committed to psychiatric hospitalization

 Has donated 1 or more units (approximately 450 mL) of blood or had an acute loss of an equivalent amount of blood within 90 days prior to study medication administration

['Placebo', 'Salmonella typhi vaccine (Typhim Vi)']

Placebo
Salmonella typhi vaccine (Typhim Vi)


Blood Pressure Interaction Between Sildenafil and Sublingual Glyceryl Trinitrate (GTN) in Men With Angina

Summary: The purpose of the study is to determine for how long sildenafil potentiates the blood pressure reduction that occurs with glyceryl trinitrate in men with angina.
Inclusion criteria: inclusion criteria:

 Male

 Stable angina with one of:

 Classical history of exertional angina pectoris

 Previous diagnostic exercise test

 Angiographic evidence of CAD

 Aged 30 to 80 years

 Weight between 60 and 100 Kg

Exclusion criteria: :

 Regular treatment with long-acting nitrates or nicorandil where these cannot be withdrawn 72 hours prior to the study

 Myocardial infarction, unstable angina, stroke or transient cerebral ischaemia within 3 months

 Systolic BP > 170 mmHg or diastolic BP > 100 mmHg

 Systolic BP < 100 mmHg or diastolic BP < 60 mmHg

 Orthostatic hypotension (> 20 mmHg fall in systolic BP on standing)

 Diabetes treated with oral hypoglycaemic agents or insulin

 Any clinically significant disease other than stable angina, excepting other cardiovascular disease risk factors, e.g. smoking, hypercholesterolaemia and diet-controlled diabetes

 Taking any drug that interacts with sildenafil

 Evidence of drug abuse

['Sildenafil citrate', 'Glyceryl trinitrate']


Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)

Summary: The purpose of the study is to determine whether surgical hemostats can minimize blood loss, need for allogeneic blood transfusions and their associated risks, and costs in patients with certain acetabular fractures requiring operative fixation via a non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical agents like platelet gel products have also been linked with improved wound healing, incidence of wound dehiscence and/or infections will also be examined. The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.
Inclusion criteria: inclusion criteria:

 Acetabular fracture deemed to require open reduction and internal fixation by one of the three principle attending surgeons.

 Fixation must require a single non-extensile posterior approach (Kocher-Langenbeck)

 Posterior wall, Posterior column, certain simple transverse and transverse associated with a posterior wall, T-type, and posterior wall-posterior column fracture types

 Ages 18-65

 Patient or family must consent to the research protocol

Exclusion criteria: :

 Not meeting the aforementioned inclusion criteria

 Unstable hemoglobin levels for three days prior to acetabular surgery (i.e. no other bleeding sources)

 Revision surgery

 Surgery occurring more than two weeks post-injury

 History of blood dyscrasias or immunocompromised patients

 Patients with medical conditions requiring anticoagulation or international normalized ratio (INR) above 1.5

 Obese patients (BMI >35)

 Known ongoing infection (local or systemic)

 Pregnant women

['Fracture Fixation', 'Intra-Articular Fractures', 'Acetabulum']

Fracture Fixation
Intra-Articular Fractures
Acetabulum


Late Compared to Early Physiotherapy Following Knee Dislocation

Summary: A knee dislocation is an unusual and extremely serious injury and is defined as complete displacement of the tibia with respect to the femur, usually with disruption of 3 or more of the stabilizing ligaments. When the knee dislocates, there is often significant damage to the soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not surprisingly, this injury is a profoundly debilitating, life-altering event, with the potential to necessitate career change in athletes and laborers alike. Current evidence indicates that operative management for these injuries is more effective at returning patients to pre-morbid range of motion (ROM) and activity than conservative management. Post operative rehabilitation programs for these patients must balance the need for stability of their surgical repair and knee ROM and functionality. Experimental data suggests that post-operative immobilization offers greater protection of the surgical reconstruction, whereas immediate, aggressive physiotherapy may be more effective at preventing arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial comparing early physiotherapy (day one post op) versus immobilization for three weeks then initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects except for progam initiation.
Inclusion criteria: inclusion criteria:

 Ambulation without aids in pre-morbid condition

 Multi-ligament knee injury with or without associated peri-articular fracture

 Operative management within three weeks of the injury

Exclusion criteria: :

 Poly-trauma with life-threatening injuries preventing rehabilitation

 Patients unable to comply with intensive rehabilitation

 Patients unable or unlikely to maintain follow-up


Hybrid Atrial Fibrillation Ablation Registry

Summary: Recently a combined approach of surgeon ablation in combination with endocardial ablation (hybrid ablation) has been introduced. This therapy has shown excellent results in patients with previous failed endocardial ablation for paroxysmal atrial fibrillation as well in patients with persistent atrial fibrillation. The investigators hypothesize that the severity of atrial remodeling in patients with atrial fibrillation can be measured by clinical factors, echocardiographic parameters, circulating biomarkers and genetic background, and that these factors can be used to identify a risk profile to predict failure of the hybrid ablation therapy in patients with atrial fibrillation. Aim of this study is to determine a risk profile based on clinical correlates, circulating biomarkers, and genetic background associated with failure of the hybrid ablation procedure, in a prospective single center registry setting. The investigators evaluate all consecutive patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim for a total of 250 participants. Extra study related procedures include blood sampling for biomarkers and genetic analysis, prolonged Holter monitoring for documentation of recurrences of atrial fibrillation/atrial flutter/atrial tachycardias, and a quality of life questionnaire. Total follow-up will be five years.~Main study endpoint is failure of the hybrid ablation procedure in patients with atrial fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia >30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day Holter monitoring.
Inclusion criteria: inclusion criteria:

 Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation.

Exclusion criteria: :

 None.


Livestock Contact and MRSA in Rural Areas

Summary: Background:~- MRSA is a type of bacteria that causes serious health problems. It can cause severe infections and is difficult to treat. MRSA has been found in a high number of people who work with some kinds of livestock, such as pigs. Researchers want to study people in rural areas, where more people work with or around livestock. They want to see if MRSA is more common or causes more serious infections in these areas.~Objectives:~- To look at the relationship between livestock handling (especially pigs) and MRSA bacteria in people in rural areas.~Eligibility:~Participants in the Agricultural Health Study in Iowa, including those who are exposed to livestock.~Healthy volunteers who are not exposed to livestock.~Design:~This study requires an initial visit and monthly follow-up surveys for 18 months.~At the first visit, participants will have throat and nose swabs to collect cell and bacteria samples. They will also complete a questionnaire about their health habits. Other questions will ask about any work that brings them into contact with livestock like cows, pigs, or chickens.~Every month for the next 17 months, participants will complete another questionnaire to record any changes in their health and livestock contact information. They will also collect throat and nose swabs. They will send the questionnaires and the swabs to the study researchers.~Participants will be paid for the first visit and for every monthly survey and swab collection they return.~No treatment will be given as part of this protocol.
Inclusion criteria: inclusion criteria:

 Cohort A: Participant or child of participant in the Agricultural Health Study

 Cohort B: Resident of Iowa

Exclusion criteria: :

 Cohort A: Age <8 months

 Cohort B: Age <8 months


Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia

Summary: The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires.~The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.
Inclusion criteria: inclusion criteria:

 Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
Exclusion criteria:

['zolpidem-MR (modified release)', 'zolpidem (SL800750)', 'placebo']

zolpidem-MR (modified release)
zolpidem (SL800750)
placebo

['Sleep Initiation and Maintenance Disorders']


Lupus Genetics Studies

Summary: The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and the Virgin Islands that have one or more living members diagnosed with SLE.
Inclusion criteria: inclusion criteria:

 Families in which one or more living members have been diagnosed with systemic lupus erythematosus
Exclusion criteria:


Bacterial Growth in Vascular Surgery Wounds

Summary: The amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area). In vascular surgery, wound infections are a common and expensive complication. The aim of the present study is to investigate the prevalence of bacteria in vascular surgery wounds perioperatively, and determine whether is correlates with the incidence of wound infections postoperatively.
Inclusion criteria: inclusion criteria:

 need for lower limb vascular by-pass surgery

Exclusion criteria: :

 allergic to cefuroxime

 patients refusal to participate


Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Summary: Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes
Inclusion criteria: inclusion criteria:

 confirmed diabetes

 neuropathic ulcer grade 1/2 (wagner scale)

 confirmed sensory neuropathy

Exclusion criteria: :

 osteomyelitis patients unable to walk

 life threatening co-morbidity ankle/brachial index , 0.4

['Neuropathic Foot Ulceration in Individuals With Diabetes']


Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy

Summary: This clinical trial studies the best time to administer the influenza vaccine to patients with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different times relative to chemotherapy may affect how well it works to help the body build an immune response and prevent influenza in these patients.
Inclusion criteria: inclusion criteria:

 Patients must have biopsy-confirmed non-hematological malignancy

 Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy

 Patients must be of age >=18 years.

 Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to influenza vaccination

 Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document

Exclusion criteria: :

 Patients who have already received the influenza vaccine during the season in which they are considered for eligibility will be excluded

 History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies

 Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination

 Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless used as part of a chemotherapy regimen

 Patients must not be on any other agents that can suppress the immune system

 Planned concurrent therapy with radiation

 Uncontrolled illness at time of enrollment or influenza vaccination including, but not limited to, ongoing or active febrile illness

 Psychiatric illness/social situations that would limit compliance with study requirements

 Known immunosuppression eg. history of organ transplantation or known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because they may not be able to mount an appropriate immune response

 History of influenza-like illness, defined as a temperature > 37.8 degree C with cough or sore throat starting October 1, 2011 throughout the duration of the study

 Patient may not be scheduled to receive chemotherapy on a weekly basis.


Dynasplint for Distal Radius Fracture

Summary: The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic modality in reducing contracture following surgical treatment of distal radius fractures.
Inclusion criteria: inclusion criteria:

 Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up

Exclusion criteria: :

 Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)

 Radial nerve entrapment

 Arthrodesis

 Traumatic dislocation of the distal ulna


Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth

Summary: Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids.
Inclusion criteria: inclusion criteria:

 Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).

 All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator.

 All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history.

 All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination.

 Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study.

 Subjects must be willing to comply with study requirements.

Exclusion criteria: :

 Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.

 Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days.

 Subjects will be excluded if they had more than one burst of systemic steroids within the past year.

 Subjects will be excluded if their baseline FEV1 is < 80% predicted.

 Subjects will be excluded if they have any other serious systemic disease other than asthma.

 Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days

 Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose.

 Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles.

 Subjects will be excluded if they have any history of tuberculosis of the respiratory tract.

 Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections.

 Subjects will be excluded if they have any history of herpes simplex infection of the eye.

 Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months.

 Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders.

 Subjects will be excluded if an investigator deems they have any mental or development health issues, such as autism, moderate to severe mental retardation or severe ADHD,that interferes with their ability to complete the knemometry measurements.

 Subjects will be excluded if an investigator deems they have any physical issues, such as inability to sit independently or amputation of lower leg, that interferes with their ability to complete the knemometry measurements.

['Fluticasone, Budesonide, Beclomethasone', 'Fluticasone, Beclomethasone, Budesonide', 'Budesonide, Fluticasone, Beclomethasone', 'Budesonide, Beclomethasone, Fluticasone', 'Beclomethasone, Fluticasone, Budesonide', 'Beclomethasone, Budesonide, Fluticasone']

Fluticasone Budesonide Beclomethasone Fluticasone Beclomethasone Budesonide Budesonide Fluticasone Beclomethasone Budesonide Beclomethasone Fluticasone Beclomethasone Fluticasone Budesonide Beclomethasone Budesonide Fluticasone


Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation

Summary: Most breastfeeding women are told by their health care provider to continue taking prenatal vitamins after they give birth. A woman's requirement for iron while breastfeeding is low, yet prenatal vitamins contain a large amount of iron. The purpose of this study is to see if breastfeeding women are getting too much iron when taking prenatal vitamins.
Inclusion criteria: inclusion criteria:

 Women less than 4 weeks postpartum

 18 years of age or older

 Took prenatal vitamins for at least 3 months during pregnancy

 Successfully initiated breastfeeding

Exclusion criteria: :

 Anemic (Hgb < 110 g/L)

['Iron Overload', 'Oxidative Stress', 'Iron-deficiency Anemia']

Iron Overload
Oxidative Stress
Iron-deficiency Anemia


Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care

Summary: South Asians (SA) living in Canada and globally have high rates of type 2 diabetes (diabetes). Despite the burden of diabetes in this population, diabetes management remains poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care.
Inclusion criteria: inclusion criteria:

 age >19 years of age

 type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes

 A1C ≥7% in past 1 year

 willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments

 ability to provide informed consent

 self identify as South Asian (from India, Pakistan, Sri Lanka, or Bangladesh) regardless of generational status or timing of immigration with ability to speak in English or Punjabi.

Exclusion criteria: :

 life- limiting illness <12 months

 physical inability to exercise

 recurrent severe hypoglycemia or hypoglycaemic unawareness

 family member of, or living in same household as a participant

 pregnancy or gestational diabetes.

['Culturally tailored diabetes program']


Early Childhood Malaria Prevention With Maloprim in The Gambia

Summary: A trial was conducted in the 1980s to compare two strategies for control of malaria in young children aged 3-59 months: treatment with chloroquine versus treatment combined with fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was assessed at the time, and their cognitive abilities and educational outcomes were assess 14 years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and mortality and would improve cognitive abilities and educational outcomes in the long term
Inclusion criteria: inclusion criteria:

 For original trial: Children aged 3-59 months present in participating villages

 For follow-up: Children who were in original trial for at least 1 year.

Exclusion criteria: :

 For original trial: None

 For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests


The Supporting Healthy Marriage Evaluation

Summary: The Supporting Healthy Marriage (SHM) evaluation was launched in 2003 to test the effectiveness of a skills-based relationship education program designed to help low- and modest-income married couples strengthen their relationships and to support more stable and more nurturing home environments and more positive outcomes for parents and their children. The evaluation was led by MDRC with Abt Associates and other partners, and it was sponsored by the Administration for Children and Families, in the U.S. Department of Health and Human Services.~SHM was a voluntary, year long, marriage education program for lower-income, married couples who had children or were expecting a child. The program provided group workshops based on structured curricula; supplemental activities to build on workshop themes; and family support services to address participation barriers, connect families with other services, and reinforce curricular themes. The study's random assignment design compared outcomes for families who were offered SHM's services with outcomes for a similar group of families who were not but could access other services in the community.
Inclusion criteria: inclusion criteria:

 To be eligible for the study, couples were supposed to be low income, married, at least 18 years old, and either expecting a child or parents of a child under age 18 who was living in their home -- though couples were not required to provide any documentation verifying that they met these eligibility criteria.

 They also had to understand one of the languages in which SHM services were offered (English or, in some locations, Spanish).

Exclusion criteria: :

 Indication of domestic violence in the relationship

['A Family-Strengthening Program for Low-Income Families']

['Low-Income Population', 'Child Behavior', 'Adolescent Behavior', 'Marital Relationships', 'Family Relations']

Low-Income Population
Child Behavior
Adolescent Behavior
Marital Relationships
Family Relations


Plating of Humeral Shaft Fractures in Multiple Trauma Patients.

Summary: The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.
Inclusion criteria: inclusion criteria:

 age > 18 years

 patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF)

 patients for whom the above fracture has healed

 patients willing and able to provide informed consent and able to participate in study procedures

Exclusion criteria: :

 patients with known pathological fractures

 patients with metabolic bone disease

 patients with humeral head or inter-articular surface fractures, or other upper extremity fractures

 patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.)

 patients with neurologic injury to upper extremities

['Humeral Fractures', 'Multiple Trauma']


Dopamine and Norepinephrine in Shock Patients

Summary: The purpose of this study is to compare the efficacy of dopamine and norepinephrine, two commonly used vasopressor agents, in the treatment of shock.
Inclusion criteria: inclusion criteria:

 Mean arterial pressure less than 70 mmHg or systolic pressure less than 100 mmHg persisting despite adequate fluid loading (in example with at least 1000 mL crystalloid or 500 ml colloid) unless central venous pressure (CVP) or pulmonary artery occluded pressure (PAOP) are elevated (e.g. CVP> 12 mmHg or PAOP > 14 mmHg).

Exclusion criteria: :

 Serious arrhythmia such as rapid atrial fibrillation (> 160/min) or ventricular tachycardia.

 Brain death.

 Open label administration of dopamine, norepinephrine, epinephrine or phenylephrine for more than 4hours.


Newborn Screening for Congenital Heart Disease

Summary: The purpose of this study is to test the accuracy of 7 indicators in screening congenital heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these indicators could be applied in the nationwide newborn CHD screening. The investigator's hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable accuracy.
Inclusion criteria: inclusion criteria:

 all consecutive live newborn infants

 between 6-72hours of age

Exclusion criteria: :

 declining the screening;

 early discharge before the screening;

 missing


Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy

Summary: SPECT was performed in 51 patients after cytoreductive surgery in combination with intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses that could be performed without further surgical intervention. SPECT data was found to predict feasibility of sequential postoperative intraperitoneal chemotherapy.
Inclusion criteria: inclusion criteria:

 Cytoreductive surgery and intraperitoneal chemotherapy

 Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment
Exclusion criteria:


Predictive Ability of the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) for Acute Exacerbations (PACE) in Patients With COPD

Summary: Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial impact on a patient's life. However, the impact of COPD is currently under-recognised and, as a result, COPD is under-treated. An exacerbation of COPD is a major element that causes poor quality of life and loss of productivity. Therefore, minimizing the frequency of exacerbations is a short term treatment goal in COPD management and could improve Quality of Life (QoL) significantly in all severity groups of COPD.~Although the use of spirometry for the determination of disease severity in COPD is supported by guidelines, a lung function test alone does not provide a measurement of the overall impact of COPD on health status and is not generally available especially in primary care centre. Therefore, a standardised and effective dialogue between patients and physicians in a consultation could address the impact of COPD on a patient's QoL in this situation.~The COPD Assessment Test (CAT), recently launched in 2009, is a short and simple, self-administered questionnaire designed to assess the condition of patients and overall impact of COPD, and to improve patient-physician communication. It has been proven that the CAT has good repeatability and discriminative properties which suggest that it is sensitive to treatment effects at a group level. The CAT score with its better ability to assess the impact of COPD on patients, suggests potential to predict a significant change in COPD status such as acute exacerbations of COPD.~Since the CAT is designed to assess the impact of COPD on the patient by measuring overall impairment, it has better correlations with other instruments, such as the Clinical COPD Questionnaire (CCQ), MRC (Medical Research Council) dyspnoea scale, St George's Respiratory Questionnaire (SGRQ),and the 6-minute walk test. However, it does not correlate well with FEV1 (Forced Expiratory Volume in One Second).~While the CAT shares some similarities with other questionnaires, there are several important differences. For example, the SGRQ is substantially longer than the CAT, is complex to administer and requires the use of a computer for scoring. The CAT is designed to provide a holistic measure of the impact of COPD on the patient, whereas the MRC dyspnoea scale only measures dyspnoea, and the CCQ only assesses clinical disease control. Thus, the CAT is the only validated, short and simple assessment test which can provide a holistic measure of the impact of COPD on patients, ensuring both the physicians and the patients gain the understanding needed to manage COPD optimally.~QoL is defined as an individual's perception of their position in their life in the context of the culture and value systems. Therefore, the extent of understanding of the questionnaire might be influenced by language and ethnicities. Since the validation findings so far have been based on data from the US and Europe, PACE may provide better quality of data across ethnic groups given that mainly Asian subjects will participate in this study.~PACE is designed to evaluate whether the CAT has a high predictive value in detecting subsequent exacerbations of COPD. If so, this result might enable both patients and physicians to better target and optimise management. The primary objective is to evaluate the predictability of the CAT to have subsequent exacerbations in COPD patients. Secondary objectives are to evaluate the predictability of the CAT to have moderate to severe exacerbations or time to the first exacerbation, to identify risk predictors for COPD exacerbations, and to evaluate correlations between CAT scores and FEV1 values, or MRC dyspnea scores. An experimental objective is to evaluate the correlation between the CAT score between 2 consecutive follow-ups (e.g. Week 8 & baseline, Week 16 & Week 8) and a COPD exacerbation over the following treatment period adjusting for demographics, MRC scores, lung function parameters, medical history, and therapy history.~PACE is a multicentre, prospective, observational study designed to evaluate the predictability of the CAT score to have COPD exacerbations over 24 weeks. During the study, subjects continue taking their regular prescribed treatment. Investigators are free to make medication adjustments where required. Eligible subjects will have a clinic visit every 8 weeks, during which they will complete the CAT questionnaire, the Exacerbation Check List (ECL), MRC dyspnea scale, and spirometry. A regular phone call is placed every 8 weeks in between clinic visits to collect data for the ECL.There is no follow-up period.~550 male and female outpatient subjects will be recruited for PACE to obtain approximately 300 exacerbation events. This study will capture the winter periods in Australia, China, Korea and Taiwan, when incidence of exacerbations is at its peak.~Statistical analysis will be performed on subjects' data to derive the PACE end-points.
Inclusion criteria: inclusion criteria:

 Type of subject: Outpatients

 Informed consent: Subjects must give their signed and dated written informed consent to participate.

 Gender: Male or Female

 Age: 40 years of age or older at Visit 1

 COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in accordance with the following definition by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC < 0.7.

 History of exacerbations: At least one COPD exacerbation which required the use of any additional treatment in the last 12 months prior to Visit 1.

 For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should have at least one COPD exacerbation that required the use of any additional treatment since diagnosis.

 Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years.

Exclusion criteria: :

 Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study

 Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis.

 Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre

['Pulmonary Disease, Chronic Obstructive']


Evaluation of the Safety of Compressive Socks to Treat Venous Insufficiency in Patients With Peripheral Arterial Disease

Summary: Elastic compression stockings are recommended in the treatment venous insufficiency. Degressive compressive stockings have been used for many decades and are characterized by a high pressure applied at the ankle and a decreasing pressure from the ankle to the knee. Progressive compressive stockings were developed to have a maximal pressure at the calf. This concept is based on the calf pump role in the venous return. Patients with PAD (Peripheral Arterial Disease) often suffer from venous insufficiency. But elastic compression stockings are strictly contraindicated for patients with PAD because highest pressures on ankle could slow down the superficial microcirculation.~On patients with PAD and venous insufficiency, the progressive compressive stockings could be well indicated. Strongest pressure at the calf should increase the pump effect and the muscle mechanical efficiency during the walk without deleterious effect.
Inclusion criteria: inclusion criteria:

 Patient suffering from a PAD (systolic pressure index ≥ 0,60 and ≤ 0,75) and having moderate venous insufficiency or classified as C1s to C4 using the CEAP classification

 Age over 18 years

 French health insurance

 Signed informed consent

Exclusion criteria: :

 Hypertension not controlled or hypertensive crisis (risk of non reproducibility of SPI and TBI)

 Diabetes

 Mediacalcosis (SPI not computable)

 Inflammatory arterial diseases of the lower limb

 Permanent edema, lipedema and lymphedema

 Wound and fragile skin

 Phlegmatia coerulea dolens

 Septic thrombophlebitis

 Severe coronary artery disease

 Oozing and infectious skin diseases, skin ulcers

 Known hypersensitivity to components of the study compressive stockings

['Peripheral Arterial Disease', 'Venous Insufficiency']

Peripheral Arterial Disease
Venous Insufficiency


Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients

Summary: The purpose of this study is to determine whether an early oral nutritional supplementation (ONS) in amyotrophic lateral sclerosis (ALS) patients is effective on the treatment of this rapidly progressive disease.
Inclusion criteria: inclusion criteria:

 Patients ≥18 years of age, diagnosed with ALS (<2 months before inclusion) according to Airlie House criteria : definite, probable, or probable laboratory supported;

 Time between first symptoms and diagnosis less than 18 months

 Sporadic or familial cases

 Patient agreement to be followed in a given ALS centre during the duration of the study

 Patients with a loss of at least 1 point in 3 items of the ALSFRS-R rating scale or with a loss of at least 2 points in 2 items of the ALSFRS-R rating scale

 Patients who signed the informed consent form

Exclusion criteria: :

 Associated dementia or inability to understand the requirements of the protocol.

 No helper

 ONS already begun

 Artificial nutrition: enteral or parenteral nutrition

 Known hypersensitivity to components of ONS

 Absence of treatment with Riluzole (RILUTEK®)

 Patient under guardianship or curatorship

 Participation in another research protocol.


Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever

Summary: The purpose of this study is determine the ability of bedide ultrasound performed in the Emergency Department and Outpatient Department can predict the severity of disease during a Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the presence of gallbladder wall thickening and/or pleural effusions in children correlates with progression to Dengue hemorrhagic fever and Dengue shock. In addition, we hypothesize that sonographic imaging of pediatric patients presenting to the emergency department with a fever during a Dengue fever outbreak will change management and disposition.
Inclusion criteria: inclusion criteria:

 Age >3 months and <16 years

 Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System)

 Not a prisoner or ward of the state

 Parents able and willing to give consent. Children older then 7 able and willing to give assent

Exclusion criteria: :

 Allergic to Ultrasound gel

 Prisoners or wards of the state

 Unstable patients

 Known pleural effusion, ascites, or gallbladder wall thickening.


The Impact of Sleep Disorders on Motor Vehicle Accidents

Summary: Patients who have sleep disorders may be involved in accidents more frequently than those without. In addition patients who have sleep disorders may have more serious accidents and have increased length of stay.We aim to recruit drivers admitted as a result of a motor vehicle accidents and to ascertain the prevalence of sleep disorders in this group.
Inclusion criteria: inclusion criteria:Drivers admitted as result of motor vehicle accidents -

Exclusion criteria: :Drivers aged < 18 years

 -


Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD

Summary: The primary objective of the study is to determine the percentage of patients with therapeutic success at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)
Inclusion criteria: inclusion criteria:

 - Presence of purulent sputum documented by colorimetric assay (Allegra et al., Resp Med 2005), plus at least two of the following signs-symptoms

 Increased cough

 Increased dyspnea

 Increase in sputum volume appeared at least 3 days

 previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin / clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted for at least 3 days with persistence or worsening of symptoms and subsequent use of hospital

 ≥ 60 years

 FEV1 <80% and ≥ 30% and ratio FEV 1 / FVC <70%

 chest x-ray negative for inflammatory infiltrates

 informed consent

Exclusion criteria: :

 asthma

 pulmonary neoplasms

 a history of allergy or hypersensitivity to quinolones

 impracticability in oral antibiotic and / or altered ability to absorption by the gastrointestinal system

 a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6 months)

 history of tendinopathy

 note or severe renal impairment creatinine> than twice the upper limit of the normal range or hepatic impairment (AST and / or ALT> twice the upper limit of the normal range)

 patients with sepsis, tuberculosis or other infections in other organs or systems

 cystic fibrosis

 patients with inherited tolerance to intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate dehydrogenase

 pregnant or breastfeeding

 drug or alcohol addiction

 experimental concomitant treatment with other drugs

['Levofloxacin 1 tablet 500 mg once a day', 'Prulifloxacin 1 tablet 600 mg once a day']


Low-Cost Molecular Cervical Cancer Screening Study

Summary: Background:~- Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative to Pap smears and visual inspection for cervical cancer screening of underserved women. Two low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3 hours to run and may provide point-of-care (diagnostic testing at or near the site of patient care) testing for HPV. Researchers are interested in evaluating both tests to determine the best strategy for HPV testing of women who live in rural or underserved areas that have a high prevalence of cervical cancer diagnoses.~Objectives:~To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting cervical cancer and precancerous lesions.~To evaluate the best low-cost test or combination of tests for women who have been referred for cervical cancer screening or treatment.~To compare the clinical performance of self-collected specimens versus clinician-collected specimens in detecting cervical cancer and precancerous lesions.~Eligibility:~- Women between 25 and 65 years of age who live in rural China.~Design:~This study involves an initial testing visit and a 1-year followup visit for a high-risk subgroup.~Participants will have the HPV E6 test, careHPV, and a visual inspection test for cervical cancer. For comparison, participants will also have the standard HPV test approved by the U.S. Food and Drug Administration.~Participants who test positive for HPV on any of the above tests will also have colposcopy to collect samples of cervical tissue for further study.~A random sample of women who test negative for HPV will also have colposcopy. Participants may also have biopsies if there is visual evidence of cervical abnormalities.~At the 1-year followup visit, participants in the high-risk subgroup will have the same tests as in the previous visit..
Inclusion criteria: inclusion criteria:

 have not been previously diagnosed with cervical cancer

 have a cervix

 are not pregnant

 are physically able to undergo routine cervical cancer screening 5) are able to provide informed consent

 We will not exclude women if they have had previous cervical cancer screening because we assume that even if a few women have been screened for cervical cancer, the quality of cytology screening was very poor.

Exclusion criteria: :

 1) are not married AND report never having had sexual intercourse 2) have had a total hysterectomy

 3) have a history of cervical cancer

 4) are physically or mentally unable to undergo routine cervical cancer screening or unable to provide informed consent.

 5) are pregnant or have been pregnant in the last month

 -Women who are currently menstruating at the time of enrollment will be deferred from participating, and will become eligible to participate 7-14 days after menstruation has ended. The menstruating women will be advised to return for the screening 7 to 14 days after their menstrual period has concluded.

['DNA Probes', 'E6 Protein', 'Uterine Cervical Neoplasms', 'HPV']

DNA Probes
E6 Protein
Uterine Cervical Neoplasms
HPV


Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure

Summary: There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality
Inclusion criteria: inclusion criteria:

 To be eligible, each patient must be in the following condition:

 Permanent atrial fibrillation (>6 months) which has been considered unsuitable for ablation or failed ablation

 Narrow QRS ≤ 110 ms

 Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control

 At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below)

Exclusion criteria: :

 New York Heart Association (NYHA) class IV and systolic blood pressure <80 mmHg despite optimized therapy;

 severe concomitant non-cardiac disease;

 need for surgical intervention;

 myocardial infarction within the previous 3 months;

 previous implanted devices (PM/ICD/CRT)

['AV junction ablation', 'CRT', 'Optimized drug therapy', 'ICD']

AV junction ablation
CRT
Optimized drug therapy
ICD


Rheumatic Heart Disease School Project

Summary: Acute rheumatic Fever (ARF) results from an autoimmune response due to molecular mimicry between the M-protein on the group A β-hemolytic streptococci (GABHS) cell membrane and cardiac myosin, and may lead through recurrent or sustained inflammation to Rheumatic Heart Disease (RHD). RHD remains a major contributor to morbidity and premature death in the working age population in Nepal. Secondary prevention with regular oral or intravenous administration of penicillin continued until early adulthood is recommended to prevent the progression of the development of endocarditis and subsequent valvular dysfunction.~Screening for rheumatic heart disease using echocardiography has the potential to detect rheumatic valvular lesions at an earlier, clinically silent stage, as compared to clinical examination alone and might have a beneficial impact on long-term outcome of children with RHD. Schoolchildren aged 5-16 years from several public and private schools from rural and urban areas in Southeastern Nepal will be screened for RHD using portable echocardiography.~Three main inter-related objectives will be pursued in three phases of the study: In a first phase using a cross sectional approach, the prevalence of clinical and subclinical RHD will be investigated among a representative sample of schoolchildren from public and private schools in urban and rural areas. In a second phase, using a cohort study approach among those children diagnosed at different stages of RHD, clinical outcomes with regular medical surveillance will be assessed (a), and clinical and social risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis will be determined (b). A third phase will integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on health resource utilization.
Inclusion criteria: inclusion criteria:

 Schoolchildren in Southeast Nepal aged 5-16 years

 Written informed consent by the principal of the school

 Passive consent from the parents

Exclusion criteria:

 No formal


New Treatment for Donor Sites

Summary: Primary research questions/Purpose of the Research.~Determine the short term (epidermal regeneration, reduction of pain, infections and length of stay) and long term (scarring, long term recovery, and cost of treatment) outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan and thrombin (HT).~Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.~b. Describe the importance of the knowledge that you expect to gain from the research.~To find a donor site dressing that has outcomes equal or better than that of scarlet red.
Inclusion criteria: inclusion criteria:

 Ages 0-90 years.

 Any patient admitted to the hospital with burn injury requiring grafting and a donor site.

Exclusion criteria: :

 Patient with severe burn injuries expected to die.

['Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]', 'Blood sample', 'Biopsy']


Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer

Summary: BACKGROUND:~Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment for LA-NHSCC. This combined modality treatment is linked with considerable acute local and systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC pathogenesis.~Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only in the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.~RATIONALE:~A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant treatment with radiotherapy associated to cetuximab does not exist.~STUDY DESIGN:~Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin (40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy with the monoclonal antibody Cetuximab (400 mg/m2 [loading dose] and subsequently 250 mg /m2/week)
Inclusion criteria: inclusion criteria:

 Histologically confirmed squamous cell carcinoma (with biopsy on the primary and / or lymph node metastases) of the oral cavity, oropharynx, hypopharynx, larynx supraglottix;

 Locally advanced disease, defined by one of the following criteria: any T, N +, M0 (excluding T1, N1), T3-4, N0, M0;

 Not cancer nasopharynx or paranasal sinuses or salivary glands;

 General conditions and associated diseases which does not allow to perform chemotherapy or radiotherapy in a radical view;

 No other surgical treatments, chemotherapy or radiotherapy for cancer of head and neck or elsewhere, except non-melanoma skin cancer or in situ cervical cancer and other solid tumors for which radical treatment has been completed > three years prior to enrollment in the study and for which the patient has remained continuously free of disease;

 Accessibility to follow-up;

 Signing of informed consent;

 Interval between examinations of local staging and randomization, maximum 3 weeks

 Interval between randomization and initiation of treatment, maximum 2 weeks

Exclusion criteria: :

 Age <18 years

 ECOG performance status > 0-1

 Hemoglobin <9 g / dL

 Counts of granulocytes, total <1.5 x 10 ^ 9 / L

 Platelet count <100 x 10 ^ 9 / L

 Bilirubin> 1.5 times upper limit of normal (ULN)

 AST or ALT> 3 times ULN

 Creatinine clearance > 50 mL/min

 Mg > 0.5 mmol/L

 Pregnancy or lactation

 Presence of allergy to study drug or to the excipients used in their formulation

 Peripheral neuropathy ≥ grade 2 (CTCAE v3.0)

 Hearing loss / tinnitus ≥ grade 3 (CTCAE v3.0)

 One of the following conditions:

 Myocardial infarction within 12 months prior to randomization

 Severe congestive heart failure

 Unstable angina

 Cardiomyopathy in act

 Ventricular arrhythmia

 uncontrolled hypertension

 Severe psychotic disorders in act

 Severe infection in act

 Any other serious illness that could interfere with the administration of the therapy provided by the protocol

['cetuximab', 'cisplatin (associated to radiotherapy)']

cetuximab
cisplatin (associated to radiotherapy)

['Head and Neck Neoplasms', 'Laryngeal Neoplasms', 'Mouth Neoplasms', 'Pharyngeal Neoplasms']

Head and Neck Neoplasms
Laryngeal Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms


Osteopathic Treatment of Low Back Pain

Summary: Eighty percent of Canadians experience low back pain (LBP) at some point in their life (Waddell, 1987), with a point prevalence of up to 30 percent (O'Sullivan, 2005; Waddell, 1987). Low back pain has severe economic ramifications. Most incidents of low back pain occur during the prime working years of life, with an estimated cost to the economy at $14,744 Canadian dollars per person per year (Health Canada, 1998). Indirect costs in the form of long-term disability were highest for disorders of arthritis and chronic back pain (Health Canada, 1998). It has been estimated that 12 percent of patients will experience disability within one year after their first episode of low back pain (Banner, 2006). Evidence based diagnosis and treatment is important for desirable outcomes.~The investigators predict that there will be changes in A) trunk muscle electromyographic patterns and in temporo-spatial gait patterns following osteopathic treatment.
Inclusion criteria: inclusion criteria:

 between the age of 19 and 55 years old,

 able to walk without assistance and /or assistive devices at least 4.7 meters.

 have adequate hearing acuity to detect verbal instructions.

 have adequate visual acuity to walk safely in usual ambient lighting without holding onto objects.

 be able to speak and comprehend English,

 have sufficient cognitive ability to follow instructions, and to provide informed consent, as defined by a Mini Mental Status Examination score of greater than 23 out of 30, performed by the research coordinator.

Exclusion criteria: :

 have had neurological signs and symptoms, or complications such as tumor or infection.

 are active in a claim pertaining to a motor vehicle accident or work injury or under any litigation for their pain.

 have had previous osteopathic treatment in the last year.

 had more than one abdominal surgery, or spinal fracture, or structural deformity such as scoliosis or spondylolithesis (Hubley-Kozey, 2002)

 have severe cardiopulmonary disease as determined by a health questionnaire with symptoms such as shortness of breath or chest pain on mild exertion or at rest,

 history of severe neurological disorder that impairs balance and mobility eg stroke, Parkinson's disease, peripheral neuropathy

 have pain that leads to severe discomfort with minimal movement,

 have significant musculoskeletal impairment e.g. arthritis that leads to severe discomfort with walking that could lead to an abnormal gait,

 have cognitive compromise impairing ability to care for oneself, and ability to provide informed consent,

 have dizziness while standing,

 have a history of falls in previous month that might make it unsafe to participate in a gait study


Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

Summary: The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac).
Inclusion criteria: inclusion criteria:

 Healthy volunteers (males or females) of ≥ 18 and ≤ 35 years of age

 Good health based on history and clinical examination (physical examination and laboratory screening)

 Negative pregnancy test

 Use of adequate contraception for females

 Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study

 Agreement to inform the general practitioner and to sign a request to release medical information concerning contraindications for participation in the study

 Willingness to undergo administration of PfSPZ Challenge by needle and syringe and willingness to undergo challenge by mosquito bites

 For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial centre or living in Nijmegen with a third party that could contact the clinicians in case of alteration of consciousness during a part of the study (day 5 after challenge until treatment is finished)

 Reachable (24/7) by mobile phone during the whole study period

 For volunteers living in Nijmegen: living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial centre during a part of the study (day 5 after challenge until treatment is finished)

 Available to attend all study visits

 Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period

 Willingness to undergo HIV, hepatitis B and hepatitis C tests

 Negative urine toxicology screening test at screening visit and the day before challenge

 Willingness to take a prophylactic regime of chloroquine and a curative regimen of Malarone®

 Willingness to undergo ophthalmologic examination after passing all other inclusion criteria

Exclusion criteria: :

 History of malaria

 Plans to travel to malaria endemic areas during the study period

 Plans to travel outside of the Netherlands during the challenge period

 Previous participation in any malaria vaccine study and/or positive serology for Pf

 Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers

 History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)

 History of arrhythmias or prolonged QT-interval

 Positive family history of 1st and/or 2nd degree relatives who experienced cardiac events when < 50 years old

 An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system

 Clinically significant abnormalities in electrocardiogram (ECG) at screening

 Body Mass Index (BMI) below 18 or above 30 kg/m2

 Any clinically significant deviation from the normal range in biochemistry or haematology blood tests

 Positive HIV, HBV or HCV tests

 Participation in any other clinical study within 30 days prior to the onset of the study

 Enrolment in any other clinical study during the study period

 For women: pregnancy or lactation

 Volunteers unable to give written informed consent

 Volunteers unable to be closely followed for social, geographic or psychological reasons

 History of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study

 A history of psychiatric disease

 A history of convulsions

 Known hypersensitivity to Malarone® or chloroquine

 The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period

 Contraindications to Malarone® or chloroquine including treatment taken by the volunteer that interferes with Malarone® or chloroquine

 Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia

 Co-workers or trainees of the departments of Medical Microbiology or Internal Medicine of the RUNMC

 Known history of sickle cell anaemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency. If there is any suspicion of G6PD deficiency (based on medical history during screening or ethnic background -Mediterranean, African, or Asian), we will assess G6PD status of that particular subject before inclusion.

 Abnormalities during ophthalmologic examination

['PfSPZ Challenge', 'Normal Saline (NS)']


Venous Site for Central Catheterization

Summary: Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.~The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.
Inclusion criteria: inclusion criteria:

 Patient admitted in the Intensive Care Unit

 Requiring Central Venous Catheterization

Exclusion criteria: :

 Patients with only one site available

['Randomization of the site for catheterization']

['Critical Care', 'Catheterization', 'ICU']

:

 Patients with only one site available


Psychosocial Support for Cancer Patients

Summary: This is an international, 3-site trial (Winnipeg Canada, MSKCC NYC, Perth Australia) accruing 120 patients per site (120x3). The purpose of this study is to compare two types of counseling for cancer patients: Dignity Psychotherapy and Supportive Psychotherapy as well as Standard Palliative Care. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. We, the investigators at Memorial Sloan-Kettering Cancer Center, have developed a type of counseling we call Dignity Psychotherapy. It is intended to help cancer patients maintain or enhance a sense of purpose, meaning, and overall quality of life, despite having cancer. Supportive Psychotherapy is another type of counseling intended to help patients feel more at ease and express and reflect on any feelings or concerns they might have about their illness. Both of these types of counseling will be compared to Standard Palliative Care. We will look at how these types of treatments affect patients' mood, outlook, and quality of life. We also want to see how the type of treatment they receive affects their family members and significant others.
Inclusion criteria: inclusion criteria:

 The patient must be at least 18 years of age (because of the nature of Dignity Psychotherapy, which presumes a relatively advanced level of social and psychological development).

 Have a terminal illness (Stage IV with a prognosis of less than 6 months, but expected to live at least 7 to 10 days, i.e. the average length of the protocol)

 Must be able to identify a family member/significant other who agrees to participate in the study (in the case of Dignity Psychotherapy, this family member/significant other will receive the generativity document)

 Be able to communicate with an English-speaking therapist (patients who are visually impaired will be offered assistance with the consent forms and surveys)

 In the investigator's judgement, participant is cognitively able to provide valid, informed consent.

Exclusion criteria: :

 Significant psychiatric disturbance sufficient to preclude participation in a psychotherapeutic intervention (e.g. acute, severe psychiatric symptoms which would require individual treatment and medication management rather than a psychotherapy intervention).

 Active psychotic mental disorder (e.g. schizophrenia, acute mania), or marked paranoid ideation. Patients who are on stable regimens of psychotropic medications (e.g. antidepressants for clinical depression) or who are in concurrent individual or group psychotherapy will not be excluded. This information regarding concurrent psychiatric treatment will be collected and utilized as a co-variate in data analysis.

 Presence of a cognitive disturbance (i.e. delirium or dementia) sufficient to preclude participation in psychotherapy, and/or data collection.

 Physical limitations or illness severity sufficient to preclude participation in psychotherapy

['Dignity Psychotherapy', 'Supportive Psychotherapy', 'Standard Palliative Care']

Dignity Psychotherapy
Supportive Psychotherapy
Standard Palliative Care