Treatment Study Comparing Manual Treatment or Advice in Acute, Musculoskeletal Chest Pain

Summary: Acute chest pain is a common cause of hospital admission. Active approaches are directed towards diagnosis and treatment of potentially life threatening conditions, especially acute coronary syndrome and coronary artery disease. However, a considerable number of patients may have chest pain caused by biomechanical dysfunction of muscles and joints of the chest wall or the cervical and thoracic spine (20%). The diagnostic approaches and treatment options for this group of patients are scarce and there is a lack of formal clinical studies and validated outcome measures addressing the effect of manual treatment approaches.~Objective: This single blind randomized clinical trial investigates whether chiropractic treatment can reduce pain and improve function in a population of patients with acute, musculoskeletal chest pain when compared to advice directed towards promoting self-management.~Methods: Among patients admitted to a chest pain clinic in a university hospital under suspicion of acute coronary syndrome, 120 patients with an episode of acute chest pain of musculoskeletal origin are included in the study. All patients have completed the chest pain clinic diagnostic procedures, and acute coronary syndrome and other obvious reasons for chest pain have been excluded. After completion of the study evaluation program, the patients are randomized into one of two groups: A) advice promoting self-management and individual instructions focusing on posture and muscle stretch; B) a course of chiropractic therapy of up to ten treatment sessions focusing on high velocity, low amplitude manipulation of the cervical and thoracic spine together with a choice of mobilisation and soft tissue techniques. In order to establish suitable outcome measures, two pilot studies were conducted. Outcome measures are pain, function, overall health, and patient-rated treatment effect measured at 4, 12, and 52 weeks following treatment.
Inclusion criteria: inclusion criteria:

 To be included in the project the participant must

 Have chest pain as their primary complaint.

 Have an acute episode of pain of less than 7 days duration before admission.

 Consent to the standardized evaluation program at the chest pain clinic.

 Have pain the in the thorax and/or neck.

 Be able to read and understand Danish. Be between 18 and 75 year of age.

 Be a resident of the Funen County.

 Patients will not be included if any of the following conditions are present

 ACS.

 Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG).

 Have a condition that is likely to results in the episode of chest pain. The condition must be verified clinically during admission (i.e. pulmonary embolism, pneumonia, dissection of the aorta, …).

 Inflammatory joint disease.

 Insulin dependent diabetes.

 Fibromyalgia.

 Malignant disease.

 Apoplexy, dementia, or unable to cooperate.

 Major osseous anomaly.

 Osteoporosis.

 Pregnancy.

 Does not want to participate.

 Other - the reason for non-inclusion will be registered.

Exclusion criteria: :

 Participants will be excluded following baseline evaluation if any of the following conditions are present

 Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below).

 New incidence of any of the above mentioned conditions/pathologies.

['Musculoskeletal Chest Pain', 'Non-cardiac Chest Pain', 'Undiagnosed Chest Pain']

Musculoskeletal Chest Pain
Non-cardiac Chest Pain
Undiagnosed Chest Pain


A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat

Summary: The study was performed to evaluate the analgesic efficacy, safety, and tolerability of valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients with moderately to severely painful symptomatic sore throat over a 24-hour period. In addition, the study was to validate a new scale and criteria for measuring pain in sore throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore throat pain on pain score and efficacy of analgesics. The study also examined what type of medications are commonly used for sore throat and whether this information has relevance to analgesic efficacy.
Inclusion criteria: inclusion criteria:

 Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing ≥66 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing.

Exclusion criteria: :

 Patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides, or acetaminophen were excluded.


Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

Summary: The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment.~All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A pregnancy test (urine test) will be conducted on all women of child-bearing age to verify that the patient is not pregnant before the rinsing procedure. The patient will fill out a short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.
Inclusion criteria: inclusion criteria:

 Female

 18-80 years of age

 TMJ arthralgia

 Masticatory myalgia

 TMJ sounds

 History of at least 6 weeks use of occlusal appliance therapy

Exclusion criteria: :

 Contraindication to sedation including pregnancy or medical history

 History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy

 History of steroidal injection into TMJ

 History of trauma to TMJ

 TMJ pain longer than 3 years

 History of narcotic drug use on a scheduled basis

 Current active infection

['Lactated Ringers', 'Triamcinolone hexacetonide']

Lactated Ringers
Triamcinolone hexacetonide


Azilect + Antidepressant Chart Review

Summary: To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD patients receiving antidepressants, but not rasagiline.
Inclusion criteria: inclusion criteria:

 Male or female patients with a diagnosis of PD

 Rasagiline treatment as mono- or adjunct therapy for PD with concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period, OR Rasagiline treatment as mono- or adjunct therapy for PD without concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period. OR Antidepressant therapy (SSRIs, SNRIs, St. John's wort and/or TCAs) and any other dopaminergic anti-PD treatment besides rasagiline or selegiline at any time during the specified review period

 Willing to consent to review of office chart and to review of records of ER visits and/or hospitalizations corresponding to the review window, if required

 Patients previously participating in a rasagiline clinical trial (and their follow-up protocols) are eligible, provided that they did not receive antidepressant therapy during trial participation.

 In addition to the above criteria, each group has specific inclusion criteria stated below:

 Group R+AD: Enrollment in this group requires that patients must have taken rasagiline and an antidepressant (SSRIs, SNRIs, St. John's wort and/or TCAs, regardless of indication) within 14 days of each other (or five weeks, if fluoxetine preceded rasagiline).

 Group R: Enrollment in this group requires patients must have at least 2 months of rasagiline use.

 Group AD: Patients must be taking an approved dopaminergic medication for PD. Enrollment in this group requires that patients must have at least 2 months of treatment with an antidepressant medication.

Exclusion criteria: :

 Use of rasagiline for any indication other than PD

 Patients taking a monoamine oxidase inhibitor (MAOI) antidepressant and/or selegiline

 Inability or unwillingness to request records of ER visits and/or hospitalizations corresponding to the review period.

['Group R+AD Rasagiline + Antidepressant', 'Group R Rasagiline', 'Group AD Anti-PD + Antidepressant']

Group R+AD Rasagiline + Antidepressant
Group R Rasagiline
Group AD Anti-PD + Antidepressant


Stereotactic Radiotherapy for Oligometastatic Prostate Cancer

Summary: This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.
Inclusion criteria: inclusion criteria:

 Able to provide informed consent.

 ECOG performance status 0-1.

 Histologic confirmation of prostate adenocarcinoma.

 Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes.

 ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases).

 All sites of disease are amenable to stereotactic radiotherapy.

Exclusion criteria: :

 Castrate resistant prostate cancer.

 Evidence of spinal cord compression.

 Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy).

 Inability to safely treat all sites of visible disease.

 Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.


Sleep Disturbance and Bipolar Disorder

Summary: The study aims to evaluate a psychological intervention for individuals who suffer from sleep disturbance and bipolar disorder. We are hoping that this treatment will: (1) improve the quality of life of individuals with bipolar disorder who are suffering from sleep disturbance and (2) reduce the risk of, or help prevent, episodes.
Inclusion criteria: inclusion criteria:

 Bipolar disorder patients with sleep disturbance

 Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Text Revision (DSM-IV-TR; APA, 2000) diagnostic criteria for bipolar disorder type 1 (established with the SCID: Structured Clinical Interview for DSM-IV).

 Being inter-episode throughout the experiment as defined by cutoffs widely used in previous research. On the basis that a drug-free group would likely be unfeasible and unrepresentative, participants will not be excluded on the basis of medications prescribed for bipolar disorder. Comorbidity will be allowed as long as bipolar disorder is the primary diagnosis. However, it is necessary to assess comorbidity for reporting purposes.

 Participants who have a history of bipolar 1 or suicidal ideation must be under the care of a psychiatrist.

 Experience distress related to significant sleep disturbance.

Exclusion criteria: :

 Presence of an active and progressive physical illness (e.g., congestive heart failure, cancer, COPD) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) directly related to the onset and course of insomnia;

 Alcohol or drug abuse (except nicotine) within the past year

 Active posttraumatic stress disorder

 Evidence of sleep apnea, restless legs syndrome or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)

 Patients who pose a current suicidal risk or homicidal risk (assessed by treating psychiatrist) or who have made a suicide attempt within the past 6 months.

 Pharmacotherapy for sleep defined as the benzodiazepine and non-benzodiazepine hypnotics that operate via the GABA A receptor complex and are FDA approved for the treatment of insomnia, selective melatonin agonists, benzodiazepine anxiolytics and over the counter medications with proven efficacy such as melatonin or herbs such as St. Johns wort.

 Use of certain medications known to alter sleep (e.g., steroids, theophylline, propranolol, antihistamines that cause drowsiness).

['Cognitive behavioral therapy for insomnia', 'Bipolar education']


Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

Summary: The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.
Inclusion criteria: inclusion criteria:

 Diagnosis of one of the following

 Newly diagnosed de novo acute myeloid leukemia (AML)

 AML secondary to myelodysplastic syndromes (MDS)

 AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years

 Bone marrow blasts >30%

 Age ≥ 65 years

 Easter Cooperative Oncology Group (ECOG) 0-2

Exclusion criteria: :

 Previous cytotoxic or biologic treatment for AML (except hydroxyurea)

 Previous treatment with azacitidine, decitabine or cytarabine

 Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)

 AML French American British subtype (FAB M3)

 AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes

 Prior bone marrow or stem cell transplantation

 Candidate for allogeneic bone marrow or stem cell transplant

 Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, in-situ carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)

 Malignant hepatic tumors

 Uncontrolled systemic infection

 Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C

 Use of any experimental drug or therapy within 28 days prior to Day 1

['Azacitidine', 'Conventional Care Regimen']


Shockwave Therapy of Chronic Diabetic Foot Ulcers

Summary: Introduction:~Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations.~Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. No side effects to ESWT have been shown.~Purpose:~The investigators want to test whether shockwave therapy can improve wound healing among diabetic patients with foot ulcers.~Hypothesis:~The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases blood flow, reduces pain, and has no side effects.~Method:~Patients who are interested in participation will be included in the study and divided by randomization into two groups of equal size. The first group is treated with ESWT in combination with regular guideline treatment. The second group is set up as control group and will only receive regular guideline treatment. The participants are examined in different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to measure tissue oxygen pressure and foot sense of touch. The foot ulcers are inspected for infection at every consultation, and a swab sample will be collected at enrollment. The size of the ulcers are measured and photographed each time. The investigators will count how many foot ulcers that are completely healed during the test period and measure the sizes of the remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and use of analgesic drugs are obtained from the patient journal and by patient interview.~Significance:~ESWT should be considered a supplement to existing clinical guidelines in wound management if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of amputations among diabetic patients will decline by implementing new treatment options for the diabetic foot.
Inclusion criteria: inclusion criteria:

 Patients receiving care and treatment in OUH Wound Clinic (Odense University Hospital, Denmark) with a diabetic foot ulcer.

 Wagner groups 1 and 2 (Wagner Ulcer Classification System)

Exclusion criteria: :

 Patients with an ulcer duration of less than 2 months

 Ulcer area less than 0,5 x 0,5 cm (or less than 0,25 cm2)

 Patients who have had vascular surgery performed within the past 2 months

 Patients who cannot give informed consent

 Patients who do not read or speak danish

 Wagner groups 3 and 4 (Wagner Ulcer Classification System)


Immunopathology of Autoimmune Hemolytic Anemia

Summary: Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.~The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.~The role of treatments, such as steroids, will also be determined in patients with warm AIHA.
Inclusion criteria: inclusion criteria:

 Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)

 Secondary AHAI (infections, hematological diseases, systemic diseases)

 Naive of treatment for hemolytic anemia or in relapse

 Older than 16

 Able to understand written and spoken French

 who have provided written informed consent

 inclusion criteria for CONTROLS

 Persons without auto-immune disease, cancer or active infection.

 Older than 16

 Able to understand written and spoken French

 who have provided written informed consent

Exclusion criteria: :

 Cold agglutinin disease

 Pregnancy

 Persons without national health insurance


Gao Bipolar Spectrum Lithium/Quetiapine Study

Summary: This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.
Inclusion criteria: inclusion criteria:

 Able to provide informed consent before beginning any study-specific procedures

 Male and female patients at least 18 years of age

 Meets Diagnostic and Statistical Manual -IV criteria for BPI, BP II, or National Comorbidity Survey-R criteria for sub-threshold BP with or without symptoms, in need of medication adjustment(s)

 Willing to be randomized to either Lithium or Quetiapine

 If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation

 Women with reproductive potential must have a negative urine pregnancy test

Exclusion criteria: :

 Unwilling to comply with study requirements

 Patients who have had severe adverse reaction to Lithium or Quetiapine

 Patients who require inpatient care

 Drug/alcohol dependence requiring immediate acute detoxification

 Pregnancy as determined by serum pregnancy test or breastfeeding

 History of nonresponse to Lithium at doses >900 mg ≥8 wks or to Quetiapine at doses of at least 300 mg/d ≥ 8 week for depression and at least 400-600 mg/d ≥ 4 wks for mania.


A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR

Summary: The study compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica.
Inclusion criteria: inclusion criteria:

 Males or females, 50 years of age or older who provided written informed consent.

 Females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).

 Subjects newly diagnosed with polymyalgia rheumatica and previously untreated with glucocorticoids for PMR. The diagnosis of polymyalgia rheumatica must be confirmed by all of the following criteria:

 New onset bilateral shoulder pain or new onset bilateral shoulder and hip girdle pain.

 PMR VAS score over the last 24 hours before the Screening Visit ≥ 50 (on a 0 - 100 scale).

 Morning stiffness duration of ≥ 45 min on the day before the Screening Visit.

 Acute phase response shown by elevated C-reactive protein (CRP; ≥ 2 times ULN).

 Subjects willing and able to participate in all aspects of the study and comply with the use of study medication.

Exclusion criteria: :

 Females who are pregnant (positive β-hCG test) or lactating.

 Subjects with any contraindication/history of hypersensitivity to predniso(lo)ne or other ingredients.

 Significant renal impairment (serume creatinine > 150 µmol/L).

 Significant hepatic impairment (ALT, AST and GGT > 2.5 ULN).

 Subjects suffering from another disease which requires glucocorticosteroid treatment. Topical glucocorticosteroids, e.g. intra-nasal or inhaled glucocorticosteroids are allowed but should be kept at a stable dose throughout the study.

 Continued use of systemic glucocorticoids within 4 weeks prior to the Screening Visit.

 Joint injections with glucocorticoids within 6 weeks prior to the Screening Visit.

 Subjects who require treatment with non-permitted concomitant therapies.

 Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease at the time of screening, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.

 Active alcohol or drug abuse.

 Subjects suffering from giant cell arteritis, late onset rheumatoid arthritis or other inflammatory rheumatoid diseases.

 Subjects suffering from drug-induced myalgia.

 Subjects suffering from fibromyalgia

 Subjects suffering from systemic lupus erythemathosus.

 Subjects suffering from neurological conditions, e.g. Parkinson's disease.

 Subjects suffering from active cancer.

 Subjects suffering from an active infection.

 Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days prior to the Screening Visit.

['Lodotra®', 'Prednisone IR (immediate release)']

Lodotra®
Prednisone IR (immediate release)


Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris

Summary: To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris
Inclusion criteria: inclusion criteria:

 Chronic stable angina pectoris

 Documented coronary artery disease

 Previous treatment with atenolol or other beta-blocker agent

 Exercise tolerance test positivity and stability

Exclusion criteria: :

 Heart rate < 60 bpm

 Congestive heart failure


To Investigate Risk of Colorectal Neoplasms in First-degree Relatives of Patients With Non-advanced Adenomas

Summary: The risk of CRC in families of patients with CRC is well established, but it is less well-defined for families of patients with adenomas. Screening recommendations to families when an index subject has an adenoma on colonoscopy are not clear. Previous studies demonstrating an increased CRC risk in close relatives of subjects with adenomas were mostly limited by the lack of a suitable comparison group, did not offer colonoscopy to all relatives or did not have verification on true status of adenoma history in the relatives. A systematic review has reported that most studies cited for risk of CRC in relatives with adenomas have not addressed the intended question. Currently International guidelines recommended screening colonoscopy in close relatives and at a younger age when there is a proband with an adenoma, however this recommendation has not been fully supported by all societies due to the lack of robust evidence. This gap in knowledge highlights the need of well-designed and adequately powered studies to estimate the risk of colorectal neoplasms in subjects who have first-degree relatives with adenomas.~Up to 30% of average risk asymptomatic individuals 50 years or older will have at least one adenoma. Based on current guidelines, nearly half the population will be counseled to undergo a colonoscopy from 40 years old based on a positive family history of adenoma. This will have enormous burden on the healthcare system if screening is implicated in all these individuals. Secondly, not all adenomas carry the same risk. Large or villous adenomas are associated with a nearly 70% increased risk of CRC in first degree relatives (FDR) whereas small adenomas may be associated with a modest increased risk 19. It is therefore important to determine the risk of colorectal neoplasms in families of subjects with non-advanced adenomas to justify more intensive screening in these individuals. Investigators hypothesize that first-degree relatives of patients with non-advanced adenoma have an increased risk of both CRC and adenomas. Investigators aim to quantify this risk, and to identify other individual patient or neoplasm characteristics that may contribute to this increased risk. In addition, Investigators aim to determine molecular alteration profiles of colonic adenoma in siblings of patients with advanced neoplasm.
Inclusion criteria: inclusion criteria:

 First-degree relatives (aged 40 to 70 years) of individuals diagnosed with non-advanced adenoma on screening colonoscopy as Cases

 FDR of patients with negative findings on colonoscopy identified during the same study period, who are of the same age group as the studied as Cohort

Exclusion criteria: :

 A FDR history of CRC

 A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam criteria

 Known Familial Adenomatous Polyposis (FAP) syndrome

 Patients and siblings with known inflammatory bowel disease

 Undergone colonoscopy examinations in the past 5 years

 Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination

 Pregnancy

['Colorectal Cancer', 'Colorectal Adenoma']


Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren

Summary: Rheumatic heart disease remains a major challenge in low and middle income countries. Early detection of clinically silent valvular lesions by screening echocardiography allows timely implementation of secondary antibiotic prevention, and may prevent progression of disease to severe valvular damage and heart failure. The objective of the study is to assess the prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently, the investigators will evaluate progression of disease in children with early stages of subclinical rheumatic heart disease.~The investigators will perform a population-based observational survey for rheumatic heart disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly selected public and private schools. Rheumatic heart disease will be documented both according to the modified World Health Organization definition and the echocardiographic criteria suggested by the World Heart Federation.
Inclusion criteria: inclusion criteria:

 Schoolchildren aged 5 to 15 years

 Written informed consent

Exclusion criteria:

['Rheumatic Heart Disease', 'Acute Rheumatic Fever']

Rheumatic Heart Disease
Acute Rheumatic Fever


Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome

Summary: The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS.
Inclusion criteria: inclusion criteria:

 PCOS diagnosis to include three of the Rotterdam criteria

Exclusion criteria: :

 pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for >/3 months before the study smokers


Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis

Summary: This study was performed to evaluate the safety and efficacy of a locally designed Assiut Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Their limited adoption reflects concerns of high cost and conflicting data regarding their safety
Inclusion criteria: inclusion criteria:

 Patients between 18 and 85 years of age,

 Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study.

 Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.

Exclusion criteria: :

 Patients were excluded from the study if the patient has

 Any procedural complication included:

 prolonged chest pain,

 transient coronary artery closure, no-flow or slow-flow phenomenon,

 hemodynamic instability,

 persistent electrocardiographic changes,

 side-branch occlusion of >1.5 mm, or

 an angiographically suboptimal result,

 Arterial access other than the right or left femoral artery ,

 Vascular perforation, thrombosis during procedure ,

 Patients with high risk of puncture site complications as:

 Bleeding diathesis,

 International normalized ratio >1.5,

 Recent thrombolysis,

 Low platelet count,

 Hematoma at the end of the procedure,

 Previous iliofemoral artery surgery or any peripheral vascular Surgery,

 Previous femoral artery complication from angiography, and

 Uncontrolled hypertension at time of procedure (>180/>110).

['Common Femoral Artery Injury', 'Other Vascular Adverse Event']

Common Femoral Artery Injury
Other Vascular Adverse Event


Norepinephrine Transporter Availability in PTSD

Summary: The objective of this proposal is to collect pilot data to characterize the binding of [11C]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD). Approximately two hundred thousand veterans will be returning stateside upon the end of combat operations in Iraq, and 13% of returning veterans will have PTSD. 15% of all war veterans will develop chronic PTSD symptoms requiring a lifetime of mental health care. Little is known about the dysregulation of PTSD veteran's neurochemical state including the noradrenergic system which plays a primary role in memory and stress response. This includes heightened anxiety, fear and hyperarousal symptoms characteristic of PTSD. The noradrenergic system is a concentration of neurons in the brainstem nucleus, locus coerulues, that have projections to the amygdale and prefrontal cortex. The norepinephrine transporter (NET) is responsible for regulating and terminating noradrenergic transmission, and is a specific marker for neuronal integrity. Hyperactivity of the noradrenergic system up-regulates NET protein. An unresolved problem in studying the noradrenergic system is identification of suitable radiopharmaceutical to non-invasively measure alterations in the density of NET. The investigators propose to address this challenge by using positron emission tomography (PET) to measure stress-induced changes in NET expression in combat-exposed war veterans with PTSD. The central hypothesis of this proposal is that war veterans with PTSD have an up-regulation of NET in the locus coerulues resulting from hyperactivity of the noradrenergic system compared to healthy controls. Through a series of experiments, the investigators will determine the in vivo binding characteristics of [11C]MENET. The investigators will use this information to optimally design an experimental protocol to measure the availability of NET in a pilot group of combat-exposed war veterans with PTSD. The aims of this proposal are: 1) Measure the uptake kinetics and whole brain distribution of [11C]MENET in combat-exposed veterans with PTSD and healthy controls, 2) Develop a quantitative kinetic model of [11C]MENET uptake to calculate the NET availability in brain. The subjects undergoing imaging in this work will be recruited by Dr. J. Douglas Bremner (Co-Investigator) at Emory University and Atlanta Veteran Affairs Hospital. Our long-term goal is to develop a longitudinal study framework to assess the NETs dysregulation during onset of PTSD as well as its transition to chronic lifetime PTSD.
Inclusion criteria: inclusion criteria:

 PTSD as determined by the Structural Clinical Interview for DSMIV (SCID) interview of PTSD and the Clinical Administered PTSD Scale (CAPS).

 Veteran with history of active duty service and currently discharged from active duty service

 Free of psychotropic medication for four weeks before the study

Exclusion criteria: :

 History of shrapnel or other foreign bodies which would preclude MRI scanning

 Meningitis

 Traumatic brain injury

 Neurological disorder or organic mental disorder

 History of loss of consciousness

 Current or lifetime history of alcohol abuse or substance abuse or dependence base on the SCID

 Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia based on the SCID

 History of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness

 Evidence of a major or neurological illness on physical examination or as a result of laboratory studies

 positive urine toxicology screen

 Current steroid use


Interpersonal Psychotherapy for Treatment Resistant Depression

Summary: The purpose of this study is to determine whether combination of antidepressant drugs plus interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant depression.
Inclusion criteria: inclusion criteria:

 Primary diagnose of unipolar treatment resistant depression

Exclusion criteria: :

 Patients diagnose of: bipolar disorder, psychosis, high suicide risk, Intellectual disability, illicit drug dependence.

 Currently in or having received psychotherapy in the last 4 weeks

['IPT+ antidepressant drugs', 'fluoxetine', 'sertraline', 'paroxetine', 'Citalopram', 'escitalopram', 'fluvoxamine', 'Venlafaxine', 'Duloxetine', 'Bupropion', 'Lithium', 'Risperidone', 'tranylcypromine', 'Imipramine', 'amitriptyline', 'Clomipramine', 'nortriptyline', 'trazodone', 'Mirtazapine', 'sulpiride']

IPT+ antidepressant drugs
fluoxetine
sertraline
paroxetine
Citalopram
escitalopram
fluvoxamine
Venlafaxine
Duloxetine
Bupropion
Lithium
Risperidone
tranylcypromine
Imipramine
amitriptyline
Clomipramine
nortriptyline
trazodone
Mirtazapine
sulpiride


Mean Reticulated Haemoglobin (Hb) Content (RetHe) Analysis of Renal Patients

Summary: Anaemia is a common complication of Chronic Kidney Disease (CKD) the management of which has been aided by the use of synthetic recombinant human erythropoietin therapy (r-HuEPO). This red cell stimulating agent creates the further complication of Functional Iron Deficiency (FID) where, despite normal iron stores, patients fail to respond to therapy as they do not possess enough available iron to meet the demand of increased red cell production. Effective response to r-HuEPO therapy depends on an appropriate monitoring of 'available' iron levels.~Previous research into the clinical utility of testing for reticulated haemoglobin concentrations (Ret He) instead of Serum Ferritin and Transferrin Saturation analysis has indicated an advantage as an iron deficient prognostic marker however, further knowledge is required on the use of this new laboratory test (RetHe) to predict Functional Iron Deficiency (FID) level and to study it's relationship with responses to therapy.~This proposed study aims to estimate a local working Normal (non deficient) and Iron Deficient Reticulated Haemoglobin Content (RET He) reference range from surplus anonamous samples. Routine monthly blood samples from Pre Dialysis and Haemodialysis patients will be used to evaluate the sensitivity and specificity of the RET He test compared to current laboratory tests and investigate its predictive ability for Functional Iron Deficiency in these patients.~Studying , measuring and statistically analysing the change in the RET He parameters in Haemodialysis and Pre Dialysis patients over 3 months will look for evidence of a direct relationship between RET He values and the patients response to therapy. The data will be used to provide a predictive picture of what levels of RET He indicate Functional Iron Deficiency.~The introduction of this test (RetHe) may provide clinicians with a one sample/one test control over iron therapies and ensure the patient gets the most benefit from erythropoietin therapy.
Inclusion criteria: inclusion criteria:

 Two groups of random routine anonamised blood samples (for use in determinimg a local normal range for the Reticulated Haemoglobin Content [RetHe])will be included in the study:

 Normal red blood cell (RBC) Indices (Hb , Haematocrit, Mean Cell Volume ande Mean Cell Haemoglobin Content) ; an attempt will be made to select an equal mixture of men / women and an appropriate age spread to provide a valid control range for the group of test subjects (renal patients) The student Investigator will ask Haematology staff to record minimum details of iron deficient patients and normal test results noted at routine validation [positive identification number (barcode)/ age / sex] - these samples will be coded and additionally analysed for RetHe test.

Exclusion criteria: :

 All renal patient who have had surgery and / or a Blood Transfusion OR bleeding episodes within the last month prior to the study are excluded as this would interfere with red cell parameters.

 All patients < 16 years and >85 years are excluded from the study.

['End-Stage Renal Failure', 'Functional Iron Deficiency']

End-Stage Renal Failure
Functional Iron Deficiency


Electrical Skin Conductance Monitoring as an Assessment of Post Operative Pain Scores

Summary: Pain has been defined as a subjective experience. Various pain assessment tools, (such as NRS) have been developed and validated to objectively monitor and treat pain. There are certain patient populations, in whom, the current pain assessment tools cannot be used effectively due to communication problems such as cognitively impaired patients. In the US, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made it mandatory to monitor and treat pain. In the absence of reliable pain assessment tools that would objectively measure pain, there is also risk of under treatment and overtreatment of pain that may lead to negative outcomes. Therefore, a monitor that is able to predict pain levels objectively, will help to achieve above goals. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.
Inclusion criteria: inclusion criteria:

 Patients undergoing unilateral THR and TKR who are between the ages of 18 and 85 regardless of the anesthesia and postoperative analgesia type.

 Patients participating in other studies may participate in this study as well

 Patients with Motor Activity Assessment Scale (MAAS) Score of 3 and 4

Exclusion criteria: :

 Age <18, >85

 History of chronic pain as defined by use of long acting opioid medication > 6 months duration.

 MAAS Score of <3 and >4.

 Anticholinergic agent use

 Patients with the following conditions:

 Autonomic neuropathy

 Pacemaker/AICD

 Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated)

 Allergy to adhesive tape

 Communication barriers

 Bilateral Procedures

 Patient with diagnosis of

 Dysautonomia

 Sympathetic dysfunction such as: Raynaud disease, Buerger disease

 Disorders of sweating such as: Acquired idiopathic generalized anhidrosis

['Total Hip Replacement (THR) and Total Knee Replacement (TKR)']


Abnormal Structure and Bone Density in Diabetes

Summary: Assumptions and Objectives: The working hypotheses are: 1 - subjects with type 1 diabetes and / or type 2, compared to subjects without diabetes are at risk for osteopenia and / or abnormal bone structure the foot (calcaneus and ankle) can lead to bone deformities, fractures and final stage of Charcot foot. These anomalies are favored by the presence of peripheral neuropathy and plasma levels of advanced glycation end products higher than in diabetic subjects without bone abnormalities.~The objectives of this research are to evaluate these anomalies quantitative and qualitative bone in the foot (calcaneus and ankle) through the use of MicroScanner. In parallel a whole body bone mineral density (BMD) and calcaneal ultrasound will be performed to measure bone mineral density as realized in clinical practice in a defined population of patients with type 1 or type 2. These bone abnormalities will be correlated with the presence of peripheral neuropathy and the rate of advanced glycation end products of proteins and reference to parameters of chronic inflammation and oxidative stress to better understand the pathophysiology and target a population at risk.~The importance of this study is paramount in the management of diabetic foot. Indeed for the moment we are dealing primarily the consequences of diabetes impact bone when bone deformities have appeared with their attendant disability and the risk of recurrent infections in areas of friction in this fragile environment. The ultimate goal is to target people with diabetes have abnormal bone subclinical and take care to avoid changes to bone deformities and find ways to treat them.
Inclusion criteria: inclusion criteria:

 Adult with type 1 or 2 diabetes with or without neuropathy

Exclusion criteria: :

 Pathology affecting bone metabolism:

 abnormalities of phosphate metabolism proved biologically hepatic,

 chronic alcoholism

 renal insufficiency (creatinine clearance < 60 ml / min)

 hyperthyroidism,

 intoxication active smoking,

 occlusive arteritis of lower limbs (IPS > IPS 1.2 or < 0.9)

 Treatment affecting bone metabolism (corticosteroids or glitazones for over 3 months in the year or bisphosphonates within 6 months)

 Known HIV positive serology

 Progressive, inflammatory disease (rheumatoid arthritis, ankylosing spondylitis, bowel inflammatory)

['Radiography', 'Urine and Blood sampling', 'Echography']

Radiography
Urine and Blood sampling
Echography


Muscle Injury Prevention & Rehabilitation in Military Personnel

Summary: The overall goal of this study is to establish a new pre-rehabilitation program in the prevention of muscle injury in the legs of healthy people serving in the military and injured individuals with muscle wasting following leg injuries. The specific goals include: 1) the amount of exercise that causes injury to healthy muscle in the lower leg of healthy people; 2) what is the effect of an intervention (pre-rehabilitation program) on decreasing how easily the muscle of the lower leg can be injured in healthy people; 3a) what amount of exercise causes injury to muscle that has recently been injured and is recovering and 3b) the effect of the new pre-rehabilitation program on the muscles of the lower leg when the muscle has recently been injured and is still recovering.~For the first goal, the investigators will determine how easily the muscle can get injured from a specific exercise in 6 healthy, conditioned men and women. Participants will perform different amounts of exercise with the lower leg muscles to see how easily the muscle can be damaged. Magnetic resonance imaging (MRI) will be used to estimate how much damage occurs with the different levels of exercise. For the second goal, the investigators will examine the effect of a new pre-rehabilitation program on decreasing how easily muscle gets damaged from the exercise we did in the first goal. The investigators will invite healthy people to participate in this goal. The investigators will use MRI, blood markers, and pain as ways of assessing muscle damage in 10 people who do the pre-rehabilitation program before exercising and 10 who do not do the new program. The third goal will focus on a) determining how easily muscle gets injured that has recently recovered from some trauma (5 people will participate in this part of the third goal), and b) determining how a pre-rehabilitation program decreases how easily a muscle that has just recovered from trauma gets injured from exercise (10 people will participate in this part of the third goal).
Inclusion criteria: inclusion criteria:

 inclusion criteria for control subjects [primary target being Reserve Officer Training Corps (ROTC) personnel]: 1) healthy individuals ages 18-40 years; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion.

Exclusion criteria:  for control subjects (primary target being ROTC personnel): 1) previous history of trauma and/or surgery to the lower extremities that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) diabetes; 4) previous traumatic head injury or post-traumatic stress disorder; 5) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia; and 6) currently performing an exercise program that specifically targets the dorsiflexor muscles.

 inclusion criteria for subjects with muscle atrophy: 1) individuals ages 18-40 years with an injury to the lower leg requiring immobilization but no surgical intervention; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion.

['Healthy Muscle Group', 'Stretch-Contract Pre-rehabilitation Group', 'Stretch-Contract Control Group', 'Muscle Atrophy']


Patient- and Physician-Based Osteoporosis Education

Summary: Osteoporosis is an important public health problem. Osteoporosis can cause serious health complications and death and leads to increased medical costs. The purpose of this study is to identify an effective method of educating patients and health care professionals about the diagnosis and treatment of osteoporosis.
Inclusion criteria: inclusion criteria For Patients:

 PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study

 At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture

 Have had an outpatient visit with a participating doctor based on Medicare outpatient claims

 inclusion criteria For Physicians:

 Primary prescribing physicians for PACE beneficiaries
Exclusion criteria:


Cough Responses to Tussive Agents in Health and Disease

Summary: The sensitivity of a persons cough reflex can be measured by getting them to breath in (inhale) irritant chemicals. The purpose of this clinical research study is to test the sensitivity of the cough reflex to a variety of chemicals that can be inhaled to see if coughing responses are different between healthy people and people with respiratory problems that make them cough.
Inclusion criteria: inclusion criteria:

 General

 Adult subjects aged 18 years and over

 Meet criteria for subject groups as outlined below

 (1) Healthy volunteers

 Non-smokers

 No history of respiratory disease

 (2) Healthy smokers

 Current smokers with smoking history of ≥10 pack years

 Spirometry within normal limits i.e. FEV1>80% predicted and FEV1/FVC ratio >75% predicted

 (3) Asthma

 Physician diagnosis of asthma

 Airways hyperresponsiveness to methacholine; PC20<16mg/ml (within last 2 years)

 Non-smokers or ex-smoker with smoking history of ≤10 pack years

 (4) COPD

 Physician diagnosis of COPD

 Ex-smokers with smoking history of ≥20 pack years

 Spirometry demonstrating airflow obstruction i.e. FEV1/FVC ratio <70%

 (5) Chronic Cough

 History of a dry cough for >8 weeks

 Normal CXR

 Non-smokers or ex-smoker with smoking history of ≤10 pack years

Exclusion criteria: :

 1) Symptoms of upper respiratory tract infection within the last 6 weeks 2) Participation in another clinical trial of an investigational drug within the last 4 weeks 3) Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate, 4) Patients with severe respiratory disease i.e. FEV1 < 1 litre, 5) Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc.

['Cough Challenge Tests', 'ambulatory cough recording', 'Cough questionnaires']

Cough Challenge Tests
ambulatory cough recording
Cough questionnaires

['Asthma', 'Chronic Obstructive Airway Disease', 'Chronic Cough']

Asthma
Chronic Obstructive Airway Disease
Chronic Cough


A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

Summary: This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.
Inclusion criteria: inclusion criteria:

 The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.

 The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory

 Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.

 No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.

 Patient has washed out of all DMARDs other that antimalarials

Exclusion criteria: :

 Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L

 History of any other autoimmune rheumatic disease other than Sjogren's syndrome

 No malignancy or history of malignancy.

 History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug


Clinical and Ultrasonographic Results of Intratissue Percutaneous Electrolysis in Lateral Epicondylitis

Summary: Lateral epicondylitis (LE) is the most common cause of lateral elbow pain. Intratissue percutaneous electrolysis (EPI technique) is a novel minimally invasive approach which consists in the application of a galvanic current through a puncture needle which produces a local inflammatory process in the soft tissue and the reparation of the affected tissue.~The purpose of this study is to evaluate the clinical and ultrasonographic effectiveness of a multimodal program using the intratissue percutaneous electrolysis technique and exercises in the short term for patients with chronic lateral epicondylitis, and to determine whether the clinical outcomes achieved decline over time.~This study is an observational one-way repeated measures design. 36 patients in a clinical setting presenting with lateral epicondylitis (mean age = 38, mean time since injury = 12.6 months) received one session of EPI per week over 4-6 weeks, associated with a home program of eccentric exercise and stretching. The main outcome measures were severity of pain (VAS, digital algometer, Cozen and Thompson tests), disability (DASH questionnaire), structural tendon changes (ultrasound), hypervascularity (power doppler) and patient's perceptions of overall outcome (4-point scale). Measurements at 6, 26 and 52 weeks follow-up included recurrence rates (increase of severity of pain or disability compared to discharge), the perception of overall outcome and success rates. Paired Student t-tests and Chi squared tests were applied to data. Enrollment into this study ended in September 2012.~All outcome measures registered significant improvements between pre-intervention and discharge. Most patients (30, i.e. 83.3%) rated overall outcome as 'successful' at 6 weeks. The ultrasonographic finding revealed that the hypoechoic regions and hypervascularity of the extensor carpi radialis brevis change significantly. At 26 and 52 weeks, all participants (32) perceived a 'successful' outcome. Recurrence rates were null after discharge, and at the 6, 26 and 52 week follow-ups.
Inclusion criteria: Individuals who meet all of the following criteria are eligible for enrollment into the study:

 inclusion criteria:

 Adult between 18-45 years of age

 Pain over the lateral humeral epicondyle provoked by at least two of the following: gripping, palpation, stretching of forearm extensor muscles and resisted wrist or middle finger extension

 Persistent pain for at least 3 months despite conservative treatments including medication (oral nonsteroidal antiinflammatory drugs (NSAIDs) and analgesics), brace application, or physiotherapy

 Patients with structural tendon changes at the origin of the extensors, demonstrated during musculoskeletal ultrasound

 Individuals who meet any of the following criteria are disqualified from enrollment of the study:

Exclusion criteria: :

 Patients with a history of advanced cervical arthrosis in the C4-C6 segments.

 Bilateral LE with central sensitization

 Symptoms compatible with posterior interosseous nerve entrapment.

 Previous surgery, fractures, trauma or previous history of rheumatic disorders in the area of the lateral epicondyle

 History of corticosteroid injection at the lateral epicondyle within the last 3 months

 Two experienced professionals performed recruitment and examination of subjects in order to assess for eligibility criteria. All eligible patients provided written informed consent.

['Intratissue percutaneous electrolysis, associated with eccentric exercise and stretching']


Usefulness of Microbiological Tests in Community-Acquired Pneumonia

Summary: The hypothesis is that community-acquired pneumonia is usually a monomicrobial infection. Therefore, early detection of the etiology allows to select the most active, narrow-spectrum, and cheap, and less toxic antibiotic agent.
Inclusion criteria: inclusion criteria:

 Age: 18 years and above

 Clinical and radiological diagnosis of community-acquired pneumonia

 Informed consent of patient

 Hospital admission

Exclusion criteria: :

 Prior hospital admission (less than 15 days)

 Alternative diagnosis at the discharge

 Immunosuppression (HIV infection, immunosuppressive therapies, neutropenia)

 Risk factors for unusual etiologies

 Patient is pregnant

['empirical versus microbiological guided treatment']


Impact of Cranioplasty On Cerebral Perfusion

Summary: The purpose of this study is to examine the impact of cranioplasty on cerebral hemodynamic and blood flow as prognostic factor in patients receiving decompressive craniectomy for Head injuries, Subarachnoid haemorrhage, intra-cerebral haemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke.
Inclusion criteria: inclusion criteria:

 Patients over 18 years of age up to 65 years

 Patients receiving a decompressive craniectomy for : severe head injuries, Subarachnoid hemorrhage, intra-cerebral hemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke and undergoing to reconstructive cranioplasty

 Patients informed about the study and giving consent

Exclusion criteria: :

 Patients being not assisted by the French NHS

 Patients allergic to CT contrast products

 Pregnant and nursing women

['Head Injuries', 'Subarachnoid Haemorrhage', 'Intra-cerebral Haemorrhage', 'Cerebral Thrombosis', 'Infarction, Middle Cerebral Artery']

Head Injuries
Subarachnoid Haemorrhage
Intra-cerebral Haemorrhage
Cerebral Thrombosis
Infarction
Middle Cerebral Artery


Special Drug Use Investigation for Botox® (Botulinum) Spasticity (BOTOX is a Registered Trademark of Allergan, Inc.)

Summary: The objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.
Inclusion criteria: inclusion criteria:

 Subjects with upper or lower limb spasticity

 Subjects must use botulinum injection for the first time

Exclusion criteria: :

 Not applicable


A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16

Summary: The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).
Inclusion criteria: inclusion criteria:

 Understanding of the study and a signed informed consent form before any study-related procedures

 Willing and able to adhere to the restrictions specified in the protocol

 Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels ≤2 x ULN; serum aspartate aminotransferase (AST) levels ≤2 x ULN

 Part 1 (healthy participants):

 a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive

 b). Healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram (ECG) performed at Screening Visit 2

 Part 2:

 a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on physician assessment at Screening Visit 2

 b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (<)2.5 at Screening Visit 2

 c). Have a prebronchodilator forced expiratory volume in the first second (FEV1) greater than or equal to (>=) 65 percent of predicted normal value at Screening Visit 2

Exclusion criteria: :

 Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation

 At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual

 Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1

 Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study

 Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1

 Part 2 (asthmatic patients): Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator

 Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma

 Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1

 Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids

 Is receiving a high-dose inhaled corticosteroid (ICS) (>500 µg/day to fluticasone or equivalent). Use of low or medium dose ICS (≤500 µg/day fluticasone or equivalent) with or without permitted controller medications, eg, long-acting Beta2 agonists (LABA), leukotriene receptor antagonists (LTRA), is allowed

['CNTO 3157 (healthy participants)', 'Placebo (healthy participants)', 'CNTO 3157 (asthmatic patients)', 'Placebo (asthmatic patients)', 'HRV-16']

CNTO 3157 (healthy participants)
Placebo (healthy participants)
CNTO 3157 (asthmatic patients)
Placebo (asthmatic patients)
HRV-16


The Effect of Anticholinergics on Cognitive Function in the Elderly

Summary: Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
Inclusion criteria: inclusion criteria:

 Female 50 or older

 Diagnosis of OAB (ICS definition)

 English literacy

 Ability to swallow oral medication

 Cognitive ability to give consent

Exclusion criteria: :

 Dementia/Depression/Delirium

 Current anticholinergic use (requires 2 week washout period)

 Current cholinesterase

 Urinary or gastric retention

 Severe decreased gastrointestinal motility

 Uncontrolled narrow-angle glaucoma

 Myasthenia gravis

 Diagnosis fo renal impairment (creatinine clearance <30 mL/min)

['Mental Competency', 'Urinary Bladder, Overactive', 'Cognitive Function']

Mental Competency
Urinary Bladder
Overactive
Cognitive Function


Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Summary: To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.
Inclusion criteria: inclusion criteria:

 Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.

 Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.

 Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

Exclusion criteria: :

 Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).

 Subjects with severe neutropenia (<500 cells/mm3)

 Subjects with hypersensitivity to oxazolidinones or vancomycin.

['Methicillin Resistant Staphylococcus Aureus (MRSA)']


Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

Summary: The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
Inclusion criteria: inclusion criteria:

 Female patients aged 18-45 years at screening

 Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease

Exclusion criteria: :

 Pregnant (including ectopic pregnancy) or breastfeeding patient

 Patients with a documented diagnosis of cancer

 Patients with a lymphatic, hematologic or coagulation disorder

 Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™

 Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.

 Patients who have participated in another clinical study within 30 days of enrolment.

 Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.


Infliximab (Remicade) for Patients With Acute Kawasaki Disease

Summary: This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.
Inclusion criteria: inclusion criteria

 To be eligible for the trial, subjects must meet all of the following criteria:

 All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure.

 Eligible subjects will be infants and children, under 18 years old, with acute KD who remain or become febrile (>/= 38.3˚ C or 101.0˚ F) after the end of the 48 h-period after completing their IVIG infusion (2gm/kg).

 Patients must have persistent or reoccurrence of fever > 48 hours of observation to be eligible for the trial.

 Prior to the initial IVIG treatment, patients must have been febrile for >/= 3 days and have met 4/5 standard clinical criteria (Table 1) - OR - patients with fever and 3/5 clinical criteria will be eligible if echocardiogram demonstrates at least one coronary artery segment with a Z score of > 2.

 Patients must present for their initial diagnosis and IVIG treatment within the first 14 days after fever onset (Illness Day 14).

 Females of childbearing potential and males must be using adequate contraception (abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the trial.

 All eligible subjects must have a chest radiograph within one week prior to first infusion of study drug with no evidence of malignancy, infection or fibrosis.

Exclusion criteria:

 If a subject has any of the following criteria, he or she may not be enrolled in the study:

 Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone equivalent daily.

 Have history of TB or TB exposure.

 Have history of histoplasmosis or coccidiomycosis.

 Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 1 month prior to first study drug administration.

 Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder.

 Have documented history of current active hepatitis B or a history of hepatitis C infection.

 Have documented history of human immunodeficiency virus (HIV) infection

 Have received a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first study drug administration).

 Have a known malignancy or history of malignancy within the 5-year period prior to first study drug administration (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence).

 Have a history of prior lymphoproliferative disease including lymphoma.

 Have multiple sclerosis or other central demyelinating disorder.

 Have received any previous treatment with infliximab or other monoclonal antibodies.

 Have used any investigational drug within 1 month prior to first study drug administration or within 5 half-lives of the investigational agent, whichever is longer.

 Are participating in another investigative trial, involving investigational agents, during participation in this trial.

 Have a history of substance abuse (drug or alcohol) within the previous 3 years.

 Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.

 Have a known allergy to murine proteins or other chimeric proteins.

 Patients with ischemic congestive heart failure.

['Infliximab (Remicade)', 'Intravenous immunoglobulin (IVIG)']

Infliximab (Remicade)
Intravenous immunoglobulin (IVIG)


Efficacy and Cost Effectiveness of Relaxation and Response to CHF

Summary: Despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (CHF) patients remain high, patients� quality of life is poor, and their health care utilization is heavy. It is therefore important to find a cost effective non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response has been found to be effective in managing CHF-related conditions. With its favorable physiological changes, the relaxation response is likely to benefit CHF patients.
Inclusion criteria: inclusion criteria:

 CHF diagnosis, NY stage 2 or 3

Exclusion criteria: :

['relaxation technique', 'educational program']

relaxation technique
educational program


Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism.

Summary: This prospective, multicenter, multinational, phase IV, interventional single-armed (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral anticoagulant in the treatment of patients with acute intermediate-risk PE based on validated imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels of cardiac troponins and natriuretic peptides) parameters and their combinations.
Inclusion criteria: inclusion criteria:

 Age ≥18 years

 Objectively confirmed diagnosis of acute PE by multidetector CT angiography, ventilation/perfusion lung scan, or selective invasive pulmonary angiography, according to established diagnostic criteria, with or without symptomatic deep vein thrombosis

 Absence of hemodynamic collapse, or decompensation, at presentation; Hemodynamic collapse or decompensation

 Intermediate-risk category of PE severity indicated by a positive (score ≥1) simplified pulmonary embolism severity index (sPESI), in combination with the presence of at least one of the following criteria at presentation:

 At least one sign of RV pressure overload/dysfunction on CT angiography or echocardiography

 Signs of myocardial injury as indicated by elevated troponin levels

 Signs of (RV) failure as indicated by NT-proBNP levels >600 pg/ml at baseline.

 Ability of the subject to understand the character and individual consequences of the clinical trial; signed and dated informed consent of the subject available before the start of any specific trial procedures

Exclusion criteria: :

 Pregnancy (a negative serum or urine pregnancy test should be available for women of child-bearing potential before study inclusion) or lactation

 Women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond

 History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product

 Participation in another clinical trial during the present clinical trial or within the last three months

 Medical or psychological condition that would not permit completion of the trial or signing of informed consent

 Use of a fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE

 Treatment with any therapeutically dosed anticoagulant for more than 48 hours prior to enrolment

 Need for long-term treatment with a low molecular weight heparin, vitamin K antagonists or NOAC, for an indication other than the index PE episode, or for antiplatelet agents except acetylsalicylic acid at a dosage ≤100 mg/day;

 Active bleeding or known significant bleeding risk (e.g., gastrointestinal ulcer, malignant neoplasms, injuries or recent surgeries of the brain, spinal cord or eyes, recent intracranial bleedings, known or suspected esophagus varices, aneurysms or intraspinal or intracranial vascular abnormalities)

 Artificial heart valves requiring treatment with an anticoagulant

 Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2

 Chronic liver disease with aminotransferase levels two times or more above the local upper limit of normal range

 Concomitant administration of strong inhibitors of P-glycoprotein like ketoconazole, cyclosporin, itraconazole or dronedarone

 Unwillingness or inability to adhere to treatment or to the follow-up visits

 Life expectancy less than 6 months


Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis

Summary: This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis.
Inclusion criteria: inclusion criteria:

 Informed consent form signed by the parents/carers

 Chronological age below 90 days inclusive

 The presence of:

 clinical signs consistent with BM (hyperthermia or hypothermia or temperature instability PLUS 1 or more neurological findings among coma, seizures, neck stiffness, apnoea, bulging fontanelle),

 OR CSF pleocytosis (≥ 20 cells/mm3)

 OR a positive Gram stain of CSF.

Exclusion criteria: :

 Presence of a CSF device

 Proven viral or fungal meningitis

 Severe congenital malformations if the infant is not to expect to survive for more than 3 months

 Other situations where the treating physician considers a different empiric antibiotic regimen necessary

 Known intolerance or contraindication to the study medication

 Participation in any other clinical study of an investigational medicinal product

 Renal failure and requirement of haemofiltration or peritoneal dialysis

 Meningitis with an organism known to be resistant to meropenem


The Effect of CRT on the Hypercapnic Ventilatory Response

Summary: Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide.
Inclusion criteria: inclusion criteria:

 Heart failure with reduced ejection fraction (<40%)

 Either no significant sleep disordered breathing or moderate to severe CSA

 Able to consent to the study

 Ambulatory

 Aged 18-100 years

Exclusion criteria: :

 Patients on Non-Invasive Ventilation

 Predominant OSA

 Unable to consent or attend for the study

['Sleep Disordered Breathing', 'Heart Failure']

Sleep Disordered Breathing
Heart Failure


Prevalence of Pneumocystis Jirovecii and of Cytomegalovirus in Bronchial Wash Fluid of Patients Undergoing Bronchoscopy

Summary: The purpose of this study is to determine the incidence of the carriage state (asymptomatic colonization) with Pneumocystis Jirovecii (Pneumocystic Carinii Pneumonia, PCP) and Cytomegalovirus (CMV)in the human lung. These are pathogens causing pneumonia in patients with suppressed immune system, but not known to cause disease in otherwise normal people. The investigators hypothesis is that a carriage state exists for these two pathogens. To test this hypothesis the investigators will examine bronchoalveolar lavage fluid for genetic material of these two pathogens. The study population will be patients undergoing fiberoptic bronchoscopy and lavage for indications other than diagnosis of a presumed opportunistic infection.
Inclusion criteria: inclusion criteria:

 Patients undergoing Fiberoptic Bronchoscopy for any indication and signing an informed consent form.

Exclusion criteria: :

 Hypoxemia < 90% at Room air

['laboratory testing of PCP and CMV genetic material']


Positive Effects of Haematococcus Astaxanthin on Oxidative Stress and Lipid Profile in Overweight and Obese Adults

Summary: The purpose of this study is to determine whether astaxanthin (ASX) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults.
Inclusion criteria: inclusion criteria:

 Subjects with BMI over 25.0 kg/m2

 Non-smoker

Exclusion criteria: :

 Excessive alcohol consumption

 Pregnant or lactating women

 Dyslipidemia, hyperglycemia, or other chronic diseases.

 Subjects who were taking vitamin supplements


Association Between Haptoglobin Genotype and Brain Swelling

Summary: Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain swelling develops causing further compression that may lead to brain herniation and death. This study investigates the neuroprotective role of haptoglobin, in minimizing the development of brain swelling following intracerebral hemorrhage.
Inclusion criteria: inclusion criteria:

 Spontaneous intracranial or intraparenchymal hemorrhage

 18-85 years of age

 Hemorrhage occurred in a supratentorial location

Exclusion criteria: :

 Inability to obtain consent within 3 days of hemorrhage onset

 Known pregnancy

 Therapeutic anticoagulation with Lovenox, Coumadin or Heparin

 Prior history of therapeutic radiation to any area

 Brain tumor

 Hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation

 Central nervous system infection

 Subdural hematoma

 Subarachnoid hemorrhage

 Chronic immunosuppression, including steroids or chemotherapy agents

 Infratentorial location

 Unable to obtain MRI due to mental status or other contraindication (metal, pacemaker, etc.)


The Effects of a Head Elevated Ramped Position During Elective Cesarean Delivery After Combined Spinal Epidural (CSE) Anesthesia

Summary: This study will randomly allocate 180 women undergoing elective C-sections under combined spinal epidural (CSE) Anesthesia at BC Women's Hospital to one of three groups: Standard Pillow under Head (Control), Head Elevated in Ramped Position immediately after regional anesthesia (HERP), or Head Elevated Ramped Position horizontally- Horizontal until establishment of anesthesia and then head elevated for the surgical procedure (HERP-H). The subjects will be monitored for blood pressure changes (hypotension), comfort levels and time to adequate level of the anesthetic block obtained with the CSE. The study will determine if positioning a parturient in the ramped position using an elevation pillow will significantly increase the time for anesthesia to reach the dermatome level of T4 as well as whether it increases maternal comfort and provides a better airway position for the parturient.
Inclusion criteria: inclusion criteria:

 Pregnancy greater than 37 weeks gestation

 ASA (American Society of Anaesthesiologists) I and II classification of health. Class I a normal healthy patient and II a patient with mild systemic disease (i.e. mild asthma)

 Mothers presenting to the assessment unit with ruptured membranes or in the early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery.

 Potential subjects need to be able to read and understand English, unless an independent translator is available.

Exclusion criteria: :

 Women having general anesthesia

 Mothers in active labour - 3cm or more dilated with regular coordinated contractions (3 in 10 minutes)

 ASA classification 3 or above

 Emergency cesarean delivery for fetal heart rate abnormalities

 Maternal age <19

 BMI >40. Obesity makes it more difficult to site the combined spinal epidural which could lead to delay in positioning the patient quickly following subarachnoid block. Obesity can result in increased venal caval compression in the supine wedge position causing epidural venous plexus engorgement and dural sac compression which may result in a high block. A later study will look at the effects of positioning in the obese patient

 Mothers with a history of known tolerance to opioids

 Uterine over distension- polyhydramnios, twin pregnancy and estimated fetal weight of over 4kg by ultrasound scan -Uterine over distension can result in increased aortocaval compression which may lead to engorgement of the epidural venous plexus and dural sac compression which may result in a high block.

 Height over 180cm and below 150cm

 Women presenting for urgent caesarean delivery will be excluded if there is less than 60 minutes between the time that the researcher can approach them regarding the study and the time that they will have their surgery.

['TROOP® elevation pillow', 'TROOP® elevation pillow', 'TROOP® elevation pillow']

TROOP® elevation pillow
TROOP® elevation pillow
TROOP® elevation pillow


High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant

Summary: The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age <29 weeks without increasing the occurrence of associated adverse effects. To assess this hypothesis the investigators planned a multicenter randomized controlled study to compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in closing PDA.
Inclusion criteria: inclusion criteria: Gestational age <29 weeks; an echocardiographic evidence of significant PDA; an age of 12 to 24 hours; and RDS necessitating respiratory support.

 -

Exclusion criteria: : Major congenital anomalies; life-threatening infection or hydrops fetalis; pulmonary hypertension; death before the conclusion of the first course of ibuprofen; urine output below 1 ml per kilogram of body weight per hour during the preceding 12 hours (with the exception of the first dose); a serum creatinine concentration of >1.5 mg/dL (129 μmol per liter); a platelet count of <50,000/mm3; a tendency to bleed, as revealed by hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools, and oozing from puncture sites.

 -


Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)

Summary: Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers and bone scans.~Methods:~This is a multicenter trial involving the University Hospitals of three major danish cities: Aalborg, Aarhus and Odense. The trial is of cross-sectional design and consists of examinations including:~Blood samples to analyze bone markers, glycemic state, kidney function and sex-hormones.~24 hour urine sample to analyze bone markers and kidney function.~Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure.~Participants:~100 type 1 diabetics and 100 type 2 diabetics recruited from outpatient clinics at Aalborg, Aarhus and Odense, general practitioners and flyers.
Inclusion criteria: inclusion criteria:

 Type 1 or type 2 diabetes.

 Age ≥ 50 years.

 Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of ± 1 in the same period.

 HbA1c level≥ 7 % through the previous six months.

 BMI between 19 og 35.

 Specific inclusion criteria for type 2 diabetes:

 Either treatment with metformin, sulfonylureas, dipeptidyl peptidase IV (DPP IV) inhibitors or glucagon-like peptide 1 (GLP-1) analogs.

 Treatment with insulin and insulin in the combination with metformin, sulfonylureas, DPP IV inhibitors or GLP-1 analogs.

Exclusion criteria: :

 HbA1C > 10%

 Pregnancy.

 Metal implanted at both ankles and wrists.

 Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives.

 Patients with a bone disease other than osteoporosis.

 Vertebral fracture visible by vertebral fracture assessment (VFA).

 Patients with renal disease defined by estimated glomerular filtration rate(eGFR) < 50.

 Other medical disease in unstable phase (fx. cancer, hyperthyroidism).

 Heart failure; New York Heart Association (NYHA) class IV.

 Patients which the investigator does not believe is fit to participate in the study

['Diabetes Mellitus', 'Osteoporosis', 'Osteopenia']

Diabetes Mellitus
Osteoporosis
Osteopenia


Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~PURPOSE: This research study is assessing fibroblast activity in patients with localized pancreatic cancer undergoing surgery.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Biopsy-proven adenocarcinoma of the pancreas or pancreatic mass suspicious for pancreatic cancer

 Localized disease

 Scheduled to undergo a resection or exploration of their pancreatic tumor

 PATIENT CHARACTERISTICS:

 Not specified

 PRIOR CONCURRENT THERAPY:

 See Disease Characteristics
Exclusion criteria:

['protein expression analysis', 'western blotting', 'immunohistochemistry staining method', 'immunologic technique', 'laboratory biomarker analysis']

protein expression analysis
western blotting
immunohistochemistry staining method
immunologic technique
laboratory biomarker analysis


Bacterial Pulmonary Infection in PICU

Summary: The purpose of this study is to develop a scoring system to allow doctors to accurately identify children on a mechanical ventilator who have bacterial pneumonia. Currently this diagnosis is very difficult to make, resulting in the overuse of antibiotics and the promotion of antibiotic-resistant bacteria in the pediatric intensive care unit (ICU). Four ICUs at 3 children's hospitals will participate. Study participants will include 150 children, ages 2 months to 17 years old who require mechanical ventilation, and in whom the bedside health care providers suspect bacterial pneumonia. Bacteria will be studied by sampling lung fluid through the breathing tube less than 12 hours after starting antibiotics, using a procedure known as non-bronchoscopic-bronchoalveolar lavage (NB-BAL). Participants may be involved in study related procedures for up to 31 days.
Inclusion criteria: inclusion criteria:

 Parent or legal guardian has signed the informed consent.

 Age greater than 48 weeks post-conception and less than 18 years of age.

 Requiring mechanical ventilation in the intensive care unit (subjects will not be intubated solely for the purpose of this study).

 Presence of an abnormal chest x-ray (CXR) as determined by the primary care team (Note: if the attending radiologist disagrees with the reading of abnormal CXR, the subject will be followed for safety and replaced for analysis).

 Initiation of antibiotics by the assigned health care providers for suspected bacterial pneumonia (must be less than or equal to 12 hours prior to undergoing non-bronchoscopic bronchoalveolar lavage [NB-BAL]).

Exclusion criteria: :

 Presence of severe hypoxia (PaO2/FIO2 < 120).

 Documented or suspected increased intracranial pressure.

 Hemodynamic instability, defined as one of the following in the 4 hours preceding study entry:

 Initiation of any inotropic or vasopressor agents at any dose to improve blood pressure or tissue perfusion.

 Increase in infusion rate of any inotropic or vasopressor agents to improve blood pressure or tissue perfusion.

 Receipt of intravenous (IV) or oral (PO) antibiotics for suspected bacterial pneumonia for greater than or equal to 12 hours prior to non-bronchoscopic bronchoalveolar lavage (NB-BAL).

 Treatment for a previous episode of suspected bacterial pneumonia within three days prior to NB-BAL.

 Coagulopathy:

 Documented platelet count <50,000 x 10^6/mL at the time of enrollment (Exception: The subject may be enrolled if he/she receives a platelet infusion as a part of routine care that is completed within one hour of NB-BAL initiation),

 Extra-corporeal circuit, requiring anticoagulation, or

 Clinically apparent bleeding deemed important by either the PI or attending intensivist.

 Previous enrollment into this study.

 Cardiopulmonary instability during routine suctioning within 6 hours of NB-BAL.

 Oscillatory ventilation.

 Cystic fibrosis.

 Single ventricle physiology.

 Positive pleural fluid culture results prior to Day -1 during the current hospitalization.


Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Summary: The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating vestibular function prior to surgery, even if vestibular function is absent according to modern assessment techniques
Inclusion criteria: inclusion criteria:

 Vestibular schwannoma advised to surgical treatment

 No measurable remaining vestibular function

Exclusion criteria: :

 impaired decision making

 neurofibromatosis

 signs for central dysfunction

 remaining vestibular function

 Patients are advised not to participate in the gentamicin arm if

 hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%

 the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss


Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study

Summary: The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents.~In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to play a custom computer game designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder.~Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan.~This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.~If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
Inclusion criteria: inclusion criteria:

 7-17 years old

 bipolar disorder type I preferred (at least 1 week of mania)

Exclusion criteria: :

 no implanted metal (no braces, no cochlear implants)

 can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder

 no active drug/alcohol abuse/dependence

['COGFLEX-skill building levels', 'COGFLEX-control condition']

COGFLEX-skill building levels
COGFLEX-control condition

['Bipolar Disorder', 'Pediatric Bipolar Disorder', 'Childhood-onset Bipolar Disorder']

Bipolar Disorder
Pediatric Bipolar Disorder
Childhood-onset Bipolar Disorder


Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems

Summary: The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of Major Depressive Disorder

 15 or more on MADRS-S

Exclusion criteria: :

 Severe depression (more than 35 on MADRS-S or based on interview)

 Severe psychiatric condition (e.g. psychosis or bipolar disorder)

 Changed medication during the last three months

['Tailored Internet-delivered CBT', 'Non-tailored Internet-delivered CBT', 'Online discussion group']

Tailored Internet-delivered CBT
Non-tailored Internet-delivered CBT
Online discussion group


Use of the Ulcerative Colitis Diet for Induction of Remission

Summary: The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of Remission. The investigators have postulated that we developed could be beneficial for patients with Ulcerative Colitis. To date, no study has explored this possibility.
Inclusion criteria: inclusion criteria:

 Informed consent

 Established diagnosis of UC disease.

 Age: 5 - 18 years ( inclusive)

 Mild to moderate active disease, 10 ≤ PUCAI ≤45.

 Stable medication (IMM/ 5ASA) use for the past 6 weeks.

 For patients who received antibiotic treatment: age 10-18 (inclusive).

Exclusion criteria: :

 Any proven infection such as positive stool culture, parasite or C.difficile.

 Use of Antibiotics

 Use of steroids in the previous two weeks only

 Patients that are refractory to full dose steroids ( 1 mg/kg/day)

 Past acute severe UC.

 Current Extra intestinal manifestation of UC.

 Pregnancy.

 A subset of patients who are on steroids and relapse during steroids treatment ≤0.5 mg/kg with mild to moderate disease activity will act as a second subset for this exploratory study.

 -

['Ulcerative Colitis Diet', 'Antibiotic cocktail']

Ulcerative Colitis Diet
Antibiotic cocktail


University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project

Summary: The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS).
Inclusion criteria: inclusion criteria:

 University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days.

 Patients must be receiving an oral loop diuretic on their home regimen or have received intravenous loop diuretic during the index hospitalization at the time of enrollment.

 Patients must have an assessment of left ventricular function within the previous 2 years.

 Patients must have LVEF ≤ 40%, or LVEF >40 with evidence of left atrial enlargement (LA dimension > 40 mm), BNP > 200 ng/ml or PCW > 18 mmHg.

Exclusion criteria: :

 Prisoners

 Residents of long term nursing facilities

 Enrollment into a hospice program

 Receiving dialysis

 Patients with dementia

 Patients with dGFR less than 20ml/min.

 Patients being worked up for heart surgery.

 Patients being worked up for heart transplant.

 Patients being evaluated for revascularization.

 Patients being evaluated for heart valve intervention.

 Patients with primary pulmonary hypertension.

['Telemonitoring', 'Flexible Diuretic Regimen']

Telemonitoring
Flexible Diuretic Regimen


Implementation Study of Dementia Guidelines in Primary Care

Summary: The purpose of this study is to determine whether a specially developed Dementia Training Program for duos of general practitioners and primary care nurses is able to increase the number dementia diagnoses in elderly people living in the community and increase the adherence to clinical dementia guidelines
Inclusion criteria: inclusion criteria:

 GP and practice or district nurse must participate as a duo

Exclusion criteria: :

 None