Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients

Summary: CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of CMV development after solid organ transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant candidates to predict the development of CMV infection after kidney transplantation.
Inclusion criteria: inclusion criteria:

 age 16 or more

 agree with written informed consent

Exclusion criteria: :

 donor CMV IgG (+) and recipient CMV IgG (-)


COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland

Summary: In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.
Inclusion criteria: inclusion criteria: - hypertension

 age > 18

 ACE-I related cough
Exclusion criteria: : - Current treatment with telmisartan

 Cholestatic disorders and severe hepatic failure

 Allergy to telmisartan

 Pregnancy and lactation period


International Multicentre Study in Advanced Anal Cancer Comparing Cisplatin Plus 5 FU vs Carboplatin Plus Weekly Paclitaxel

Summary: Anal cancer is a relatively uncommon disease and there is currently no standard chemotherapy treatment for patients with inoperable locally recurrent or metastatic disease. The aim of this phase II study is compare two well known and largely used chemotherapy regimens - Cisplatin plus 5-fluorouracil vs Carboplatin plus Paclitaxel. The result of this study will set a standard of care for this disease and provide useful information for future Phase III trials.
Inclusion criteria: inclusion criteria

 Histologically or cytologically verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus.

 Age ≥18 years.

 ECOG Performance status ≤2.

 Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.

 Previous definitive chemoradiotherapy is permitted for early stage squamous cell carcinoma of the anus.

 HIV+ patients will be considered eligible with a CD4 count of ≥200.

 Adequate cardiac and respiratory function; absolute neutrophil count (ANC) ≥1.5x10^9/l; white blood cell (WBC) count ≥3x10^9/l; platelets >100x10^9/l; haemoglobin (Hb) ≥9g/dl; creatinine clearance >50ml/minute; serum bilirubin ≤1.5x upper limit of normal (ULN); alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5x ULN; alkaline phosphatase (ALP) ≤3x ULN.

 Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy.

 Life expectancy of at least 3 months.

Exclusion criteria:

 Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are excluded.

 Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus

 Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.

 Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.

 Surgery or palliative radiotherapy within 28 days of randomisation.

 Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure.

 History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.

 Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted).

 Acute hepatitis C and/or chronic active hepatitis B infection.

 Serious active infection requiring i.v. antibiotics at enrolment.

 Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.

 Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial.

 Known hypersensitivity to any of the study drugs or excipients.

 Known peripheral neuropathy ≥ grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).

 Pre-existing hearing impairment.

 Patients planning for a live vaccine.

 Pregnant or lactating females.

['Cisplatin', '5-Fluorouracil (5-FU)', 'Carboplatin', 'Paclitaxel']

Cisplatin
5-Fluorouracil (5-FU)
Carboplatin
Paclitaxel


Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries

Summary: Adult patients, age ≥ 18 years, with clinically diagnosed mild, moderate or severe brain trauma will be asked to participate in the study. This prospective database will consist of 400 subjects with TBI, 200 from both TUCH and Cambridge Addenbrooke's Hospital. In addition, 100 controls will be recruited, with 50 from both centres.This study is a prospective clinical observational study with detailed data collecting. All patients will be treated according to the accepted, standardized, existing guidelines that are based on national and international recommendations. New treatment interventions will NOT be evaluated during the data acquisition for this study.
Inclusion criteria: inclusion criteria:

 Severe or moderate brain trauma subjects with need of ICU care:

 Glasgow Coma Score (GCS) ≤ 8 after the primary stabilization has been performed in the field (= patient not hypoxic or hypotensive) and at least 30 min interval from the moment of injury.

 GCS 9 - 13 and the patient is deteriorating

 The patient has GCS ≤ 13 and has other injuries, which require interventions for hemodynamic or ventilatory incidents

 The patient is in urgent need of neurosurgery (craniotomy, impression skull fracture, severe haemorrhagic contusion, or ICP measurement)

 Moderate or mild brain trauma not in need of ICU care:

 - All other patients who fulfil the diagnostic criteria for an acute TBI but without any
Exclusion criteria:  defined below


Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.

Summary: The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each of these two medications with placebos.
Inclusion criteria: inclusion criteria:

 Written informed consent is obtained.

 The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age (inclusive).

 Patient reports insomnia for at least six months, and insomnia causes the patient distress.

 The Investigator determines that the patient meets diagnostic criteria for Chronic Insomnia according to International Classification of Sleep Disorders (ICSD) criteria.

 Sleep diary based screening shows sleep onset latency >30 minutes, and /or wake after sleep onset >30 minutes per night at least 3 nights per week, with combined wake-time-in-bed _> 45 minutes.

 The patient is in good health as determined by a medical and psychiatric history, and physical examination.

 Women must be surgically sterile, 2 years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control, and agree to continued use of this method for the duration of the study.

 The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.

Exclusion criteria: :

 Has any clinically significant, uncontrolled medical or psychiatric conditions. (treated or untreated)

 Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia.

 Used any prescription drugs disallowed by the protocol or clinically significant use of over-the counter(OTC) drugs within 14 days before the screening visit.

 Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V.

 Has a clinically significant deviation from normal in the physical examination.

 Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)

 Has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery and succinic semialdehyde dehydrogenase deficiency)

 Has a known clinically significant drug sensitivity to sodium oxybate or sedative hypnotics.

['zolpidem tartrate', 'sodium oxybate', 'Matching Placebos']

zolpidem tartrate
sodium oxybate
Matching Placebos

['Sleep Initiation and Maintenance Disorders']


The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps

Summary: The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding
Inclusion criteria: inclusion criteria:

 Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen

 Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure).

Exclusion criteria: :

 Patients younger than 18 years of age

 Patients with a platelet count of less than 50000, INR larger than 1.5

 Patients who refused to give their informed consent.


Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation

Summary: Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.~Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.
Inclusion criteria: inclusion criteria:

 All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications:

 Trauma of the lower leg

 Surgery of the lower leg followed by lower leg immobilization with a plaster cast

 Non-traumatic indications

Exclusion criteria: :

 Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy)

 Pregnancy

 Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists.

 History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence)

 Mental of physical disability to fulfill study requirements

 Insufficient knowledge of the Dutch language

 Previous participation in the Pot-(K)Cast study

['Deep Venous Thrombosis', 'Pulmonary Embolism']

Deep Venous Thrombosis
Pulmonary Embolism


Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy

Summary: A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).~CRO is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.Its safety and efficacy in the first 12-24 hours post operative has not been established.
Inclusion criteria: inclusion criteria:

 Local ethic committee approval

 Written informed consent

 ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH

Exclusion criteria: :

 Difficulty in communication

 Allergy to oxycodone and/or morphine

 Allergy to local anesthetic

 History of alcohol and substance abuse

 Treated depression

 Chronic use of opioid or tramadol or NSAIDS

 Pregnancy

 Obstructive sleep apnea

 Anticipated fiber optic intubation

 Severe hepatic or renal impairment

 Weight <50 kg or > 100 kg

 Conversion to laparotomy

 Patient extubated in PACU.

 Any prior abdominal surgery

['Elective Laproscopic Bilateral Inguinal Hernia', 'Elective Laproscopic Cholecystectomy']


Effects of Individualized Exercise Training in Patients With Peripheral Arterial Disease

Summary: The study is designed to investigate individualized exercise training effects on arterial function, walking ability and quality of life in subjects with peripheral arterial disease post surgery.
Inclusion criteria: inclusion criteria:

 Peripheral arterial disease post surgery > 1 month

 No discharge of surgical incision

 Intermittent claudication post invasive treatment

Exclusion criteria: :

 Necrosis

 Above/below knee amputee

 Other conditions might affect peripheral vascular elasticity


Improving Decision Making About Feeding Options for Dementia

Summary: This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.
Inclusion criteria: inclusion criteria:

 dementia diagnosis

 advanced cognitive impairment

 feeding problem

 age >= 65

 surrogate decision maker

Exclusion criteria: :

 feeding tube decision made

 hospice

 BMI > 26

 major psychosis or developmental delay

['Feeding Options in Dementia Decision Aid']


Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

Summary: This prospective randomized study aims to determine whether intermittent pneumatic compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures.~At two weeks post surgery, the IPC intervention will be ended and both patient groups will be immobilized in an orthosis until follow-up at six weeks.~The endpoint of the first part of the study is VTE events. The primary outcome will be the DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by two ultrasonographers masked to the treatment allocation. Secondary outcome will be the DVT-incidence at 6 weeks.~1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography.~The endpoint of the second part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair.~The endpoint of the third part of the study is the functional outcome of the patients at one year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.
Inclusion criteria: inclusion criteria:

 Achilles tendon rupture operated on within 96 hours of diagnose.

Exclusion criteria: :

 Inability or refusal to give informed consent for participation in the study

 Ongoing treatment with anticoagulant therapy

 Inability to comply with the study instructions

 Known kidney disorder

 Heart failure with pitting oedema

 Thrombophlebitis

 Recent thromboembolic event (during the preceding 3 months)

 Recent surgery (during the preceding month)

 Presence of known malignancy

 Current bleeding disorder

 Pregnancy

['Intermittent pneumatic compression (IPC)']

['Rupture', 'Venous Thromboembolism', 'Venous Thrombosis', 'Surgical Wound Infection']

Rupture
Venous Thromboembolism
Venous Thrombosis
Surgical Wound Infection


Clinical Trial of Mifepristone for Bipolar Depression

Summary: Bipolar Depression is a severe illness with high rates of psychiatric comorbidity and increased mortality related to suicide and medical illness. Hypothalamic pituitary axis (HPA) hyperactivity are found in bipolar disorder related to depression and mixed states. Patients with bipolar disorder also have cognitive difficulties and endocrine disturbances may contribute to such dysfunction. Antiglucorticoid therapies are novel treatments of mood disorder. Preliminary data in psychotic depression suggesting that mifepristone (RU-486), a glucocorticoid receptor antagonist, has antidepressant and salutary cognitive effects in a matter of days. In this study we examine the effects of mifepristone in severe bipolar depression in a parallel, double blind placebo controlled experiment. Bipolar subjects maintained on either lithium or valproate, after washout or prior antidepressants have a detailed neuroendocrine assessment. Patients approximately or almost 75 will receive eight days of mifepristone versus placebo after which patients are blindly crossed over to the opposite arm. Patients and a group of matched controls approximately or almost 35 will be compared with neuroendocrine, cognitive, and neurophysiologic testing to fully characterize their phenotype and explore biomarkers of response. It is hypothesized that stigmata of HPA axis hyperactivity and cognitive impairment will be predictive of response to antiglucocorticoid therapy with mifepristone.
Inclusion criteria: HEALTHY VOLUNTEERS ARE CURRENTLY NOT BEING RECRUITED FOR THIS STUDY.

 inclusion criteria FOR BIPOLAR PATIENTS:

 Patients must meet the following inclusion criteria in order to participate in the study:

 Male or female inpatients in need of treatment for severe bipolar depression.

 18-75 years of age.

 Women of childbearing potential must be using an adequate form of contraception as defined by one of the following: 1) a barrier method and 2) oral contraceptives plus a barrier method (women who are on an OCP will be kept on it others must agree to use only a barrier method).

 DSM-IV diagnosis of bipolar depression I/II, severe, with or without psychotic features.

 A current major depressive episode of at least 6 weeks' duration.

 Score of greater than or equal to 18 on the first 17-item HAM-D at the prestudy visit and at the first baseline phase visit.

 Score of 15 or greater on the HAM-D (17) at the end of the baseline period(s) (i.e., at randomization no more than 20% less than entry enrollment criteria).

 Score of greater than or equal to 4 on the CGI-BP scale at the prestudy and first visit and end of baseline phase.

 Judged to be in good physical health on the basis of medical history, physical examination, and laboratory screening.

 Able to understand procedures and agree to participate in the study by giving written informed consent.

 On lithium and/or valproate for at least 4 weeks (2 levels, 1 wk apart)

 However patients not on a mood stabilizer can have this started as an outpatient or inpatient for 4 weeks as discussed above.

 Able to come off of prior drugs and PRN zolpidem and lorazepam by start of baseline.

Exclusion criteria:  FOR BIPOLAR PATIENTS:

 Patients will be excluded from the study if they meet any of the following criteria:

 Women who are pregnant, intending to become pregnant in the next month or breast-feeding.

 Treatment with any of the following therapies within the specified interval prior to baseline: Fluoxetine - 4 weeks; Investigational compounds 4 weeks; MAOIs 1 week; Other antidepressants 1 week.

 Contraindication or history of hypersensitivity to mifepristone as well as cortisol, and CRH.

 Clinically significant organ system disease where mifepristone would be contraindicated or interfere with medical treatment.

 Have evidence of any disorder that represents a contraindication to the use of mifepristone (such as adrenal disease or a condition requiring chronic corticosteroid administration).

 History of Addison's Disease, Cushing's Disease, insulin dependent diabetes, or other uncompensated endocrine conditions.

 Evidence of infection, severe liver, respiratory, or renal disease.

 Have clinically significant cardiovascular disease, e.g., angina, valve disease, arrhythmia, cardiac failure.

 Anemia (hemoglobin less than 10 g/dL or hematocrit less than 30%)

 Have a known clotting defect or are receiving anticoagulants.

 Rapid cycling in the last year (defined as greater than 6 episodes).

 History of porphyrias.

 Clinically significant abnormalities in physical exam, ECG, or laboratory assessments.

 History of any disease which, in the investigator's opinion may confound the results of the study or pose an additional risk, including but not limited to, history of organic mental disorder, seizures, or mental retardation.

 Substance dependence that is not in sustained full remission (DSM-IV definition)

 Other principal psychiatric diagnosis judged by the investigator to dominate the clinical presentation. In particular, patients with depressive symptoms more than 2 years in duration should be carefully evaluated to determine whether another psychiatric diagnosis exists which could interfere with efficacy and safety measurements.

 History of nonresponse to greater than four trials of antidepressants for the current episode (not including mood stabilizers) will exclude subjects.

 inclusion criteria FOR NORMAL CONTROLS:

 SCID-NP- no psychiatric diagnosis lifetime.

 Ages 18-75.

 Medically and psychiatrically healthy by history and no disallowed medications for 2 weeks, and agrees to no alcohol use for 1 week baseline period of study.

 No history of mood or anxiety disorder in first-degree relatives.

 Women of childbearing potential must be using adequate form of contraception as defined by one of the following: 1) a barrier method and 2) oral contraceptives plus a barrier method.


Pre-biotics and Probiotics for Constipation in Parkinson's Disease

Summary: Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have been investigated and are now available for the management of constipation in PD. Preliminary data have suggested that probiotics could be help improving bowel habits but high-quality randomized trials are required in this area. Therefore, the investigators designed a randomized trial to evaluate whether the use of a fermented milk containing multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD compared to placebo.
Inclusion criteria: inclusion criteria:

 diagnosis of constipation according to Roma III criteria

 complete bowel movements per week <3

 total bowel movements per week <6

 written informed consent

Exclusion criteria: :

 report of loose (mushy) or watery stool in the absence of laxative use

 ongoing artificial nutrition

 lactose intolerance

 chronic inflammatory bowel disease

 previous abdominal surgery

 use of anti-cholinergics

 use of antibiotics in the 6 weeks before baseline visit

 Radio- chemotherapy

 Cognitive decline (Mini Mental State Examination <27)


Diagnosing Pneumonia Under Low-resource Conditions

Summary: Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million children under the age of 5 years, every year. This is more than the number of children dying from AIDS, malaria and tuberculosis combined. The current diagnostic and management protocols for managing serious respiratory diseases in children are 30 years old and are greatly in need of updating. The successful establishment of useful clinical management criteria for children with respiratory diseases will have benefits for children in low resource regions around the world. The goals of the study are:~To determine if children with respiratory distress can be reliably diagnosed under low-resource conditions.~To identify the clinical tests that best differentiate pneumonia from wheezy diseases. These will be used to establish updated diagnostic criteria for common pediatric lung diseases that broaden the current pneumonia algorithm by adding another for wheezy illnesses.~The ultimate objective is to improve the management and outcome of acute respiratory conditions in children.~Investigators also wish to test the efficacy of a locally developed cell phone oximeter probe in a low resource setting.
Inclusion criteria: inclusion criteria:

 All children below 5 exceeding WHO age-dependent tachypnea criteria.

Exclusion criteria: :

 None


Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty

Summary: The purpose of this study is to establish whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.
Inclusion criteria: inclusion criteria:

 Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach

 Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year

Exclusion criteria: :

 Patients with pre-existing known coagulopathy

 Patients on chronic Coumadin (Warfarin) therapy

 Patients receiving erythropoietin therapy for anemia

['Aquamantys', 'standard electrocautery (Bovie)']

Aquamantys
standard electrocautery (Bovie)

['Osteoarthritis, Hip', 'Joint Deformities, Acquired', 'Hip Dislocation, Congenital', 'Osteonecrosis', 'Arthritis, Rheumatoid']

Osteoarthritis
Hip
Joint Deformities
Acquired
Hip Dislocation
Congenital
Osteonecrosis
Arthritis
Rheumatoid


Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb

Summary: Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer.~However, the pathophysiological abnormalities are not entirely clear in how raised venous pressure translates into the changes seen in the skin culminating in an open ulcer. The standard treatment of this condition in the United Kingdom is to undertaken compression bandaging of the lower limb.~In order to further their knowledge of venous ulceration, the investigators seek to determine the biological profile of venous ulcers over a maximum of twenty-eight weeks and by dividing the groups into healing and non-healing wounds, the investigators may be able to demonstrate a difference in the biological profile.~This work may provide insights into predicting who will respond to treatment and targets for treatment in the future.
Inclusion criteria: inclusion criteria:

 Male or female over the age of 18 years

 Chronic venous ulceration - Defined as wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85.

 Ulceration present for at least four weeks.

 Colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction.

Exclusion criteria: :

 Acute infection in the studied lower limb within the last four weeks

 History of malignancy in the lower limb to be studied

 History of connective tissue disease

 Patients on medications that can cause immunosuppression - Corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications.


Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis

Summary: The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.
Inclusion criteria: inclusion criteria:

 Chronic renal failure requiring hemodialysis.

 No medical history of central vena catheterization.

 Maintenance hemodialysis after central vena catheterization.

 Signed informed consent.

Exclusion criteria: :

 Had been performed central venous puncture or catheterization before.

 Can not use heparin.

 Refused to sign the informed consent.

 Advanced cancer patients.

 With or will take arteriovenous fistula surgery in right arm.

 Other inappropriate situation

['GamCath®', 'Arteriovenous fistula creation', 'GamCath®', 'Arteriovenous fistula creation']

GamCath®
Arteriovenous fistula creation
GamCath®
Arteriovenous fistula creation

['Renal Failure Chronic Requiring Hemodialysis', 'Central Venous Catheterization', 'Inadequate Hemodialysis Blood Flow', 'Venous Stenosis', 'Venous Thrombosis', 'Infection Due to Central Venous Catheter', 'Central Venous Catheter Thrombosis']


Targeted Vessel Ablation of Type 3 Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound

Summary: So-called type 1 and 2 uterine fibroids are well treatable with Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). The other type, type 3 fibroids, however, are known for their high perfusion and poor treatment outcome after MR-HIFU. This study proposes a new strategy to treat type 3 fibroids with MR-HIFU. Very precise, small, high-power sonications (heating points) will be used to occlude (part of) the feeding vessels of the fibroid. This deminishes the negative effect of the high perfusion and is hypothesized to transform a type 3 fibroid into a type 2 or possibly even a type 1 fibroid. Consequently, the bulk volume of the fibroid can be treated using the standard approach.
Inclusion criteria: inclusion criteria:

 Able to give informed consent;

 A type 3 uterine fibroid;

 Sufficient physical condition to undergo deep sedation;

 Waist circumference that allows positioning on the HIFU table top inside the MR bore.

Exclusion criteria: :

 Contra-indication for MRI scanning according to the hospital guidelines;

 Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR <30 mL/min/1.73 m2);

 Surgical clips or considerable scar tissue in the HIFU beam path;

 A total of more than ten fibroids;

 Post- or peri-menopausal status;

 Fibroid size >10 cm in diameter;

 Patient has an active pelvic infection;

 Patient has an undiagnosed pelvic mass outside the uterus;

 Patient who is not able to tolerate the required stationary prone position during treatment.

['Magnetic Resonance guided High Intensity Focused Ultrasound']


Chest Wall Repair of Rib Fractures After Trauma

Summary: This is a prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course.
Inclusion criteria: inclusion criteria:

 Subjects must be at least >18 years of age

 Subjects must have one of the following clinical indications:

 >3 rib flail segments with paradoxical chest wall movement

 Non-repair of defect may result in pulmonary hernia

 Minimal associated injuries

 Severely displaced fractures are significantly impeding lung expansion.

 Failure of narcotics or epidural pain catheter to control pain

Exclusion criteria: :

 Significant pulmonary contusion

 Significant brain injury (AIS 4 and/or ICP monitoring)

 Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization

 Subjects not expected to survive the 90-day follow-up period

 Known pregnancy

 Prisoners


Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder

Summary: Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed suicide in adolescence, and is further associated with poor psychosocial functioning, substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychosocial intervention for adolescents with bipolar disorder has great potential to decrease the substantial morbidity, mortality and costs associated with adolescent bipolar disorder.
Inclusion criteria: inclusion criteria: For the proposed study, inclusion criteria are as follows: 1) age 12 years, 0 months to 18 years, 11 months; 2) a diagnosis of Bipolar Disorder (BP) I, II or NOS by the K-SADS-PL with an acute manic, mixed or depressive episode in the 3 months preceding study entry; 3) willing to engage in pharmacotherapy treatment at the CABS specialty clinic; 4) at least one parent or guardian with whom the patient lives or interacts on a significant basis (5 hours per week or more) who is willing to participate in DBT skills training; 5) English language fluency and at minimum a 3rd grade literacy level; 6) able and willing to give informed consent/assent to participate.

Exclusion criteria: : For the proposed study,

['Dialectical Behavior Therapy', 'Standard of Care Psychotherapy', 'Pharmacotherapy']

Dialectical Behavior Therapy
Standard of Care Psychotherapy
Pharmacotherapy

['Dialectical Behavior Therapy + Pharmacotherapy', 'Standard of Care Psychotherapy + Pharmacotherapy']


Transmission and the Respiratory Tract in Cryptosporidiosis

Summary: Cryptosporidium is an intestinal parasite that causes diarrhea in children and adults. In addition to infection of the stomach, this parasite can infect the respiratory system causing a cough and/or problems breathing. This study will enroll 480 children between the ages of 9 and 36 months who come to Mulago Hospital for treatment of diarrhea. Researchers believe a large number of children with diarrhea and cough will have the parasite present in their sputum (mucus coughed up). Researchers also believe that children who have respiratory tract cryptosporidiosis may have a cough, increased number of breaths per minute, and/or a lower oxygen level. Blood, stool, saliva, and sputum samples will be collected from all children in the study and tested for Cryptosporidium. Children too young to provide a sputum sample will have a tube placed to collect a mucus sample from the lungs. Study participation may be as short as 4 hours or as long as 2 days depending on each child's health.
Inclusion criteria: inclusion criteria:

 Male and female children aged 9-36 months at the time of enrollment

 Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; >14 days duration for persistent diarrhea)

 Child's parent/guardian speaks English or Luganda

 Parent/guardian provides full and free informed consent for child to participate in study

Exclusion criteria: :

 Unknown age

 Known cardiac, CNS, metabolic or endocrine disorders

 Moribund children

 Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation


Application of Digital Infrared Thermal Imaging (DITI) in Graves' Disease

Summary: Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. Pathogenesis involves autoimmune process. The investigators think temperatures of the area involved in the inflammation may change. Thus the investigators plan to take temperature pictures of Graves' patients using digital infrared thermal imaging system and observe the change.
Inclusion criteria: inclusion criteria:

 Graves' disease patients. Healthy people

Exclusion criteria: :

 Pregnancy. <16 years old or > 60 years old


Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Summary: The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.
Inclusion criteria: inclusion criteria:

 Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry

 Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria [2003], excluding Class III [C], IV-S [C] and IV-G [C], or the World Health Organization Class III or IV classification criteria [1982], excluding Class IIIc, IVd). If the renal biopsy was performed >3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA >upper limit of normal range.

 A stable serum creatinine ≤3 mg/dL

Exclusion criteria: :

 Subjects with a rise in serum creatinine of ≥1 mg/dL within 1 month prior to the screening visit

 Subjects with drug-induced SLE, as opposed to idiopathic SLE

 Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus

 Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis [MS])

 Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).

 Subjects who have received treatment with rituximab < 6 months prior to the screening visit

['Corticosteroids (prednisone or prednisolone)', 'Abatacept', 'Abatacept', 'Mycophenolate mofetil (MMF)', 'Abatacept']


Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy

Summary: The choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now.~The primary end point of this study is whether the rate of reflux esophagitis is different or not between LAPG and LATG. Through this study, we
Inclusion criteria: inclusion criteria:

 Age 20

 80

 Informed consent

 No other malignancies

 Proximal gastric cancer met by following conditions

 Lesion located on proximal stomach (upper one third)

 Lesion below 5cm in size

 Lesion confined to proper muscle depth (cT2)

 No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. (cN1)

Exclusion criteria: :

 If patients is only suitable to total gastrectomy, he will be excluded.


Prospective Research in Memory Clinics (PRIME)

Summary: The purpose of the PRIME Study is to examine the current management and outcomes of patients with mild cognitive impairment or dementia. Approximately 4500 patients will be enrolled in this disease registry across 12 sites in Australia. Clinical, treatment, health status and economic data will be acquired over 3 years. The study will identify the relationships among demographic variables, prognostic features, geographic setting, treatment options and clinical, economic and health status (activities of daily living and caregiver impact) outcomes.
Inclusion criteria: inclusion criteria:

 Diagnosis of dementia under the DSM-IV criteria, or of Mild Cognitive Impairment, using the Peterson Criteria

 Living in the community (home, apartment or collective housing with nursing care available for less than 40 hours per week)

 Patient able to provide written informed consent, or provision of written informed consent by a legal guardian/proxy

 Availability of a caregiver willing to provide consent for required components of the study

 Fluent in English

 May be participating in a Phase IV or other post-marketing follow up study of an approved product for treatment of dementia

Exclusion criteria: :

 No concomitant life-threatening illness (a condition which is likely to interfere with the patient's ability to complete the study)

 Not unwilling or unable to complete the study

 Not concurrently participating in a clinical trial of an investigational drug (phase I, II or III)

 Unwillingness of patient or legal guardian / proxy to provide written informed consent

 Unwillingness of caregiver to provide written informed consent

 For patients with diagnosis of mild cognitive impairment: current or previous treatment with any cholinesterase or memantine

['Current treatment practice of each participating physician']

['Dementia', 'Mild Cognitive Impairment']


The Effect of Calcium on Postprandial Lipid Profile and Appetite

Summary: The purpose of this study is to investigate the effect of calcium on postprandial lipid profile and appetite.
Inclusion criteria: inclusion criteria:

 healthy meals

 BMI 24-31 kg/m2

 age between 18-50 years

 hemoglobin >8 mmol/L

Exclusion criteria: :

 donation of blood 6 months before and under the study

 milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease

 use of dietary supplements 3 months before and under the study

 smoking

 elite athletes

 use of medication


Weight Loss Maintenance and Compensatory Mechanisms Activated With a Very-low Calorie Diet

Summary: Very-low calorie diets are relatively safe and effective in inducing significant weight loss, when used in selective individuals and under clinical supervision. However, weight loss maintenance in the long-term remains the main challenge, with many experiencing a significant weight regain. Several compensatory mechanisms are activated under weight reduction, both at the level of energy intake (such as increased appetite) and energy expenditure (such as reduced energy expenditure), and increase the risk of relapse.~The main aim of this study is to compare the effect of two multidisciplinary lifestyle interventions on weight loss maintenance at one year, after initial weight loss during 8 weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an outpatient program in the obesity unit of the local hospital, or to an inpatient program consisting of a continuous care intervention, with three intermittent stays (each with three-week duration) in a rehabilitation center over a one year period. Moreover, the investigators aim to assess the impact of weight loss (achieved with a very low calorie diet) and weight loss maintenance on compensatory mechanisms activated during weight reduction.
Inclusion criteria: inclusion criteria:

 volunteers from Central Norway

 if female: taking oral contraceptives or post-menopausal

 body mass index 30-45 kg/m2

 stable weight (<2kg variation in the last 3 months)

 not currently dieting to lose weight

Exclusion criteria: :

 Pregnancy

 breast feeding

 drug or alcohol abuse within the last two years

 current medication known to affect appetite or induce weight loss

 enrollment in another obesity treatment program

 history of psychological disorders

 history of eating disorders

 history of diabetes type 1 or 2

 gastrointestinal disorders (particular cholelithiasis)

 kidney -, liver -, lung- or cardiovascular disease

 malignancies

['Multidisciplinary outpatient program', 'Inpatient lifestyle program']

Multidisciplinary outpatient program
Inpatient lifestyle program


Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy

Summary: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
Inclusion criteria: inclusion criteria:

 Female or male subject of 2 to 17 years of age (inclusive).

 Uni- or bilateral Cerebral Palsy (CP) with clinical need for injections with NT 201 for the treatment of upper limb (UL) spasticity at least unilaterally.

 Ashworth Scale (AS) score in the main clinical target patterns in this study:

 Flexed elbow: AS≥2 in elbow flexors (at least unilaterally). and/or

 Flexed Wrist: AS≥2 in wrist flexors (at least unilaterally).

 Clinical need according to the judgment of the investigator in one out of five treatment combinations (A-E, as shown below). AS score must be ≥2 for each target pattern chosen for injection at the Baseline Injection Visit V2.

 A. UL(s) treatment only (GMFCS I-V):

 A1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:

 At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).

 and

 Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.

 or

 A2) Bilateral treatment of UL spasticity with equal doses of 8 U/kg BW NT 201 (maximum of 200 U) to each UL. Dose per UL must be distributed between:

 At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).

 and

 Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.

 B. Unilateral UL and unilateral lower limb (LL) treatment (GMFCS I-V):

 B1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:

 At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).

 and

 Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.

 plus

 B2) Ipsilateral unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U). Dose to LL must be distributed to at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe as clinically needed.

 C. Unilateral UL and bilateral LL treatment (GMFCS I-III)

 C1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:

 At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).

 and

 Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.

 plus

 C2) Bilateral treatment of LL spasticity with 12 U/kg BW (maximum of 300 U). Dose must be distributed into at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe, on each side. Dose distribution may vary between sides as clinically needed.

 D. Unilateral UL and bilateral LL treatment (GMFCS IV and V)

 D1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:

 At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).

 and

 Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.

 plus

 D2) Bilateral treatment of LL spasticity with 8 U/kg BW (maximum of 200 U). Dose must be distributed into at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe, on each side. Dose distribution may vary between sides as clinically needed.

 E. Bilateral UL treatment and bilateral LL treatment (GMFCS I-III)

 E1) Bilateral treatment of UL spasticity with equal doses of 8 U/kg BW NT 201 (maximum of 200 U) to each UL. Dose per UL must be distributed between

 At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW) and

 Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.

 plus

 E2) Bilateral treatment of LL spasticity with 4 U/kg BW (maximum of 100 U). Dose must be distributed into at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe, on each side. Dose distribution may vary between sides as clinically needed.

Exclusion criteria: :

 Pre-treated (non-naïve) subjects must not have received BoNT treatment within the last 14 weeks prior to Screening Visit (V1) in any indication.

['IncobotulinumtoxinA (8 Units per kg body weight)', 'IncobotulinumtoxinA (6 Units per kg body weight)', 'IncobotulinumtoxinA (2 Units per kg body weight)']


ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

Summary: Primary Objective:~To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.~Secondary Objectives:~To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).~To evaluate the safety and tolerability of alirocumab.~To evaluate the effect of alirocumab on lipid parameters.
Inclusion criteria: inclusion criteria :

 Recently (< 52 weeks) hospitalized for ACS.

Exclusion criteria: :

 Age < 40 years.

 ACS event occurring more than 52 weeks prior to randomization visit.

 LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL (<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59 mmol/L) with evidence-based medical and dietary management of dyslipidemia.

 The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.


Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery

Summary: A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.
Inclusion criteria: inclusion criteria:

 Patients who are scheduled for elective Cardiac or Thoracic Surgery.

 Age > 18 years of age.

Exclusion criteria: :

 Patients with a clinical suspicion or a documented history of DVT/PE

 Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively)

 Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively.

 Documented allergy to heparin, desirudin, or lepirudin

 Patients with a history of coagulation disorder

 Platelet count< 100 X109 /dl

 Active bleeding

 Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min

 Patients with a baseline coagulopathy (INR > 1.5 or aPTT > 45 sec)

 Patients with liver disease

 Pregnancy

 Patients who require ventricular assist devices before or after surgery


Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema

Summary: The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
Inclusion criteria: inclusion criteria:

 Willing and able to provide informed consent and to participate in the study

 Age > or = 40 years at the time of the screening

 Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan

 Minimum of 2 subsegments appropriate for treatment

 MRCD questionnaire score of 2 or greater at screening

 Failure of medical therapy to provide relief of symptoms

 Spirometry 15 minutes after administration of bronchodilator (BOTH):

 FEV1 < 50 % predicted.

 FEV1/FVC ratio <70 %

 Lung volumes by plethysmography (BOTH):

 Total Lung Capacity (TLC) > 100 % predicted

 Residual Volume (RV) > 150 % predicted

 Diffusing Capacity of Carbon Monoxide(DLco) > = 20 and < = 60 percent predicted

 Oxygen saturation (SpO2) > 90 % on < or = 4 L/min supplemental O2, at rest

 Six-Minute Walk Test distance > or = 150 m

 Abstinence from smoking for at least 16 weeks prior to screening

Exclusion criteria: :

 Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation

 Requirement for ventilator support (invasive or non-invasive)

 Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit

 Pulmonary hypertension, defined as:

 Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report

 If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg

 Clinically significant asthma (reversible airway obstruction) or bronchiectasis

 CT scan: Presence of the following radiologic abnormalities:

 Pulmonary nodule on CT scan greater that 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET)

 Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate

 Significant interstitial lung disease

 Significant pleural disease

 Giant bullous disease (a predominant bulla > 10 cm in all dimensions >1 / 3 of the hemithorax)

 Use of systemic steroids > 20 mg/day or equivalent, immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted)

 Allergy or sensitivity to medications required to safely undergo AeriSeal System treatment

 Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the screening visit

 Body mass index < 15 kg/m2 or > 35 kg/m2

 Female patient pregnant or breast-feeding or planning to be pregnant in the next year

 Significant comorbidity that carries prohibitive risks or is associated with less than 2-year expected survival, including any of the following:

 HIV/AIDS

 Active malignancy

 Stroke or Transient Ischemia Attack (TIA) within 12 months of screening

 Myocardial infarction within 12 months of screening

 Congestive heart failure within 12 months of screening defined at clinical evidence of right or left hear failure or left ventricular ejection fraction < 45 % on echocardiogram

 Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits

['AeriSeal Emphysematous Lung Sealant Syst']

['Emphysema', 'Chronic Obstructive Pulmonary Disease (COPD)']


Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children

Summary: The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
Inclusion criteria: inclusion criteria:

 children aged 2 through 17 years (17 years included)

 suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the arrival at emergency department)

 within the first 12 hours after the injury

 at least one signed parental informed consent

 affiliated to health insurance

Exclusion criteria: :

 analgesic treatment within the 6 hours before inclusion

 contraindication to one of the experimental drug: Paracetamol or Ibuprofen

 contraindication to Morphine

 cognitive impairment

 multiple injuries

 resuscitation manœuvres

 suspected femur fracture

 open fracture

 pregnant women in the third trimester

['Paracetamol', 'Ibuprofen', 'paracetamol + ibuprofen', 'Placebo']

Paracetamol
Ibuprofen
paracetamol + ibuprofen
Placebo


High Intensity Strength Training & Bone Mineral Density in Young Women

Summary: The current guidelines emphasize the prevention of bone loss, by building up bone mass in young age, as one of the most important measures to reduce the incidence of osteoporosis. Strength training and explosive exercises have been shown to have beneficial effects on bone mass and bone metabolism in both young and postmenopausal women. However, meta-analysis concludes that it is still unclear what type of exercises, intensity and execution that is most effective for skeletal adaptations. The following study will examine the effect of 12 weeks of heavy, explosive strength training on bone mineral density and bone metabolism in young, healthy girls aged 18-30 years.
Inclusion criteria: inclusion criteria:

 Participants include young and healthy women between the ages of 18-30, who have not engaged in strength training for the last 6 months.

Exclusion criteria: :

 Subjects will be excluded from the study if they have any condition that preclude them from taking part in the exercise testing procedures or the 24 week exercise program or if they fail to obtain the required amount of training sessions.

['Heavy, explosive strength training', 'recommendations']

Heavy
explosive strength training
recommendations


Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.

Summary: Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in serum.
Inclusion criteria: inclusion criteria:

 presence of delirium

Exclusion criteria: :

 presence of Alzheimer's disease

 any mental disorder

 presence of cancer


Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

Summary: The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
Inclusion criteria: inclusion criteria:

 Healthy male subjects

 Caucasian origin

 Age: between 18 and 55 years (inclusive)

 Body mass index (BMI) within 18-30 kg/m²

 Body weight at least 50 kg, at most 100 kg

 Non-smoker (or ex-smoker ≥1 year), proven by urine cotinine <500 ng/ml

 Clinically acceptable supine blood pressure and pulse rate, i.e. BP 100-145 mmHg systolic, 60-90 mmHg diastolic and pulse rate 50-100 bpm

 Normal ECG

 Participants must perform an adequate contraception during the study and until 6 months after the last dose of the present trial

 Ability to communicate well with the investigator and comply with the requirements of the entire study

 Written consent

Exclusion criteria: :

 Subjects with contraindications for budesonide

 Subjects with contraindications for metronidazole

 History or current clinical evidence of any cardiac, cardio-vascular, pulmonary, gastrointestinal, (cholangio-)hepatic, renal, endocrine, neurological, musculoskeletal, ophthalmological, infectious, haematological, oncological, psychiatric, or other acute or chronic diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption and/or pharmacokinetics

 History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food

 Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables

 Current smoker or ex-smoker ≤ 1 year

 Excessive alcohol consumption (³ 35 g/day in males)

 Abuse of drugs

 Positive drug screening

 Positive anti-HIV-test, HBsAg-test or anti-HCV-test

 Proneness to orthostatic dysregulation, faintings, or blackouts

 Heavy tea or coffee drinkers (more than 1 l ≈ 6 cups per day)

 Administration of glucocorticosteroids within 6 weeks prior to study day 1 or during the trial

 Repeated use of drugs during the last 4 weeks prior to study day 1 or during the trial, which might influence hepatic biotransformation

 Any medication including OTC medication within the last 14 days prior to study day 1 or during the trial (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives)

 Intake of grapefruit-containing food or beverages within 7 days prior to study day 1 or during the trial

 Clinically relevant acute or chronic bacterial, fungal or viral infections

 Surgery of the gastrointestinal tract which may interfere with drug absorption (not applicable for minor abdominal surgery such as e.g. appendectomy and herniotomy)

 Vegetarian diet or other peculiar dietary habits which would preclude the subject's acceptance of standardized (non-vegetarian) meals

 Subjects suspected or known not to follow instructions

 Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study

 Patients known to be in financial difficulties, which could interfere with their appraisal of the informative instructions

 Vulnerable subjects (e.g., persons kept in detention or persons who are depending on the sponsor or the investigator)

 Blood donation or other blood loss of more than 400 ml within the last 2 months prior to study day 1

 Participation in a clinical trial within the last 2 months prior to study day 1 (assessed by anamnestic inquiry)

['Budesonide 2 single doses, Metronidazole multiple-dose']

Budesonide 2 single doses
Metronidazole multiple-dose


Sexual Function Questionnaire Total Hip Replacement

Summary: Non-commercial trial~2 Centres involved: University Hospital Southampton and Spire Southampton~Expected number of eligible participants available per year: 100, (95% expected to agree to participation)~The study will recruit prospectively female patients aged 18 - 65 years undergoing THR. A retrospective series of similar patients who have had a hip replacement will also be recruited.~This is a research project that will run over 2 years. Data from 200 patients will be collected and analysed:~Retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Post-operative' Version 1.3 11/07/14~Prospective 23 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Pre-operative' Version 1.3 11/07/14~This project is significant in exploring an area of Orthopaedic medicine that has been little discussed in the literature. Preliminary results of our questionnaires have already revealed patients have a great desire to know how hip replacement will affect sexual function. Components of the questionnaire look at details such as: reasonable time frames for returning to sexual activity, positions that may be undesirable following replacement and which may lead to dislocation, concurrent use of analgesia and psychosexual aspects of total hip replacement surgery. The ultimate objective is to provide patients with detailed information about what to expect after hip replacement surgery.
Inclusion criteria: inclusion criteria:

 Female

 Sexually active

 Heterosexual

 18- 65 years undergoing THR (prospective) or having undergone THR surgery within the last year

Exclusion criteria: :

 Sexually inactive pre-operatively and wishing to remain sexually inactive post-operatively

 Unable to comprehend English and with capacity to consent and follow instruction

 Unable to sign and date the ethics committee approved consent documentation

['Prospective - Factors affecting sexual function pre-THR', 'Retrospective- Factors affecting sexual function post-THR']


Compression in Anklefracture Treatment, The CAT-study

Summary: The aim of this project is to find out if compression treatment can lower the incidens of surgical wound complications, such as infection and wound rupture, in patients with ankle fractures. The compression regime consists of a two-layered compression stocking applied after surgery and a massage boot applied both before and after surgery.~The largest part of the study is the clinical trial, with which we aim to prove the hypothesis:~* That the compression regime reduces wound infections from 10-40% to 5% on patients with a broken ankle (Either one side of the ankle, two or three sides (including the posterior part of the ankle))
Inclusion criteria: inclusion criteria:

 All patients operated on Nordsjællands Hospital, department of Orthopaedic surgery, during the inclusion period, for mono-, bi- and trimalleolar fracture, according to the AO-principles.

 Age above 18 years.

Exclusion criteria: :

 Sub study 1:

 Age under 18

 Dementia

 Need for external fixation

 Known or suspected DVT or pulmonary embolism

 Patients without Danish CPR-number, or address in Denmark

 Patients who doesn´t want to participate or who are not able to give written or oral consent

 No palpable pulse in the foot in the affected leg (the posterior tibial,- or dorsal artery)

 Multi-traumatized patients and patients with fractures of more than one extremity

 Sub study 2:

 Age under 18

 Dementia

 Need for external fixation

 Multi-traumatized patients and patients with fractures of more than one extremity

['Flowtron Hydroven and Coban2 Lite', 'Braun frame', 'compression bandage']

Flowtron Hydroven and Coban2 Lite
Braun frame
compression bandage


Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic Blocks

Summary: This study is intended to evaluate a monitor that will facilitate ascertainment of an effective sympathetic blockade following Lumbar Sympathetic blocks. Utilization of a monitor with a rapid response and easy clinical applicability which can demonstrate effective sympathetic block would increase efficiency within the procedure suite and also serve to function as an objective endpoint for the evaluation of sympathetic blockade in future research.In current clinical practice, the most commonly used monitoring methods are clinical observations of sympathetic blockade, skin temperature monitoring, pulse pressure monitoring and any combination of these monitoring methods. The skin temperature and pulse pressure may increase after sympathetic block. However, changes in the skin temperature and pulse pressure often demonstrate an unpredictable or delayed response. Confounding variables, such as ambient temperature, coexisting vascular disease, use of other vasoactive medications may contribute to inconsistencies in the temperature or pulse pressure responses.~Normal sympathetic activity stimulates muscarinic receptors in the periphery that subsequently stimulate the sweat glands to secrete and fill with sweat containing sodium and other electrolytes. The electrolytes present in the sweat increase the electrical conductance while decreasing the electrical resistance at the skin level.~The real-time changes in skin conductance indices can be monitored at the skin level, by use of non-invasive electrodes attached to the skin (similar to EKG electrodes). A computer program analyzes the data and produces a real-time graphic and numeric data demonstrating the skin conductance response. The initiation of successful sympathetic blockade can cause rapid cessation of the skin sympathetic activity that leads to a decrease in skin conductance within seconds.
Inclusion criteria: inclusion criteria:

 Patients presenting for sympathetic block of the lower extremity (lumbar sympathetic block)

 Ages 18-99

Exclusion criteria: :

 Patients with pacemakers or cardiac defibrillators

 Age <18

 IV sedation for anxiolysis or analgesia

 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

 Patient with diagnosis of: Dysautonomia, Sympathetic dysfunction (e.g.,Raynaud disease, Buerger disease) or Disorders of sweating (e.g.,Acquired idiopathic generalized anhidrosis)

 Patients on vasoactive drugs

['Lumbar Sympathetic Block', 'Skin conductance algesimeter']

Lumbar Sympathetic Block
Skin conductance algesimeter


Superselective Administration of VErapamil During Recanalization in Acute Ischemic Stroke

Summary: The purpose of this study is to determine whether super-selective intra-arterial administration of verapamil immediately following successful intra-arterial thrombolysis is safe as a potential neuroprotective agent. Standard procedures are cerebral angiography and intra-arterial thrombolysis (intra-arterial administration of tPA and/or mechanical thrombectomy). Experimental procedure is superselective injection of verapamil intra-arterially.
Inclusion criteria: inclusion criteria:

 Patients 21-85 years old, male or female

 Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.

 Patients must meet criteria for intra-arterial thrombolysis as determined and documented by Interventional Neuroradiology attending physician (JF or AA).

 Patients must have an acute thromboembolus within an intracranial artery (internal carotid, anterior cerebral, middle cerebral, posterior cerebral, basilar, vertebral) which undergoes pharmacologic (tissue plasminogen activator - tPA) and/or mechanical (eg. Merci or Penumbra clot retrieval) thrombolysis.

 Patients with impaired capacity may be included, as the pathology to be studied (stroke) may impair their capacity (please see attached required documentation regarding impaired capacity).

 Patients must have a TICI 2A or better revascularization via intra-arterial thrombolysis.

 For reference, the TICI Scale is defined below:

 0 = No Perfusion

 = Perfusion past the initial obstruction but limited distal branch filling with little or slow distal perfusion

 A = Perfusion of less than 50% of the vascular distribution of the occluded artery

 2B = Perfusion of 50% or greater (but not complete) of the vascular distribution of the occluded artery 3 = Full perfusion with filling of all distal branches

Exclusion criteria: :

 Pregnant women (would not qualify for intra-arterial thrombolysis as standard of care).

 Patients who undergo intra-arterial thrombolysis for acute stroke, in whom only TICI 0 or 1 revascularization is obtained.

 Patients with occlusion of the cervical common or internal carotid artery will be excluded from the study.


Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma

Summary: Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to 20% are metastatic.~Further to the initial standard care, about 45% of the patients relapse within a median duration of 20 months.~Result of the OS94 study results and of the investigation performed within the CRLCC, indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each year in FRANCE.~According to several studies, the 5-year overall survival rate of patients in first relapse is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are also reported in the COSS study, with a median time to second relapse of 0.8 year.~At present, there is no reference treatment for the standard care of osteosarcoma relapse in FRANCE.~Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study from our institution reported that about 35% of all osteosarcoma relapses are treated with a high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never been assessed.~These results highlight the need to the evaluate the efficacy and tolerance of this high-dose of thiotepa within a clinical trial and its inclusion in the standard care of the osteosarcoma at relapse.
Inclusion criteria: inclusion criteria:

 Age > 1 year and < 50 years

 First osteosarcoma relapse, either local or metastatic, or second relapse after exclusive surgery NB: Whenever possible, only patients with histological evidence of relapse will be included.

 Indication for chemotherapy confirmed by a multidisciplinary committee.

 Surgical resection of all tumor sites must be possible, either as first-line therapy or after chemotherapy.

 Lansky score ≥ 60%, or ECOG Performance Status ≤ 2

 ≥ 21-day interval after first-line chemotherapy

 Blood tests, renal and liver functions within the normal range for age with, in particular, 7 days prior to study entry, blood or serum values as follows:

 blood: neutrophil count > 1 G/L; platelets >100 G/L

 renal: serum creatinine ≤ 1.5 x ULN depending on age; patients with serum creatinine values > 1.5 x ULN are eligible if creatinine clearance is > 70 mL/min/1.73 m²

 liver: total bilirubin < 2 x ULN; ASAT and ALAT ≤ 5 x ULN

 cardiac: isotopic or echographic Left Ventricular Ejection Fraction > 50 %.

 Signed written informed consent; for children, signed consent from the patient (depending on age) and from the parents or legal representative is mandatory

 Documented negative serum βHCG for female patients of childbearing age

 Affiliation with health insurance.

Exclusion criteria: :

 Patients with multiple relapses for whom surgical resection seems impossible, even after chemotherapy.

 Patients already treated with high-dose chemotherapy regimens

 Patients with a contra-indication to the treatment proposed

 Patients not eligible for leukapheresis

 Two-year follow-up impossible due to social, family, geographic or psychological reasons

 Patient included in another protocol of clinical research

 Pregnant or lactating women.


Cardiac Arrest Recovery EEG Study

Summary: The purpose of the study is to collect EEG's as close to the cardiac arrest as possible using a standard hospital EEG machine and an investigational EEG device to help determine the neurological status of the cardiac arrest patient and to help decide on possible treatment and chance of recovery. The investigational EEG machine will be simple to operate as well as easy to interpret for the clinician and the nurses. It is not to replace the electrophysiologist interpretation but to determine ealy on if further evaluation and treatment can help the patient.
Inclusion criteria: inclusion criteria:

 Cardiac Arrest:

 Patients 18 years and older:

 with cardiac arrest in the hospital and successfully resuscitated, or

 with cardiac arrest out of the hospital and successfully resuscitated

 ICD patients:

 Patients 18 years and older:

 Who are undergoing elective procedure in the electrophysiology laboratory for placement of a cardiac defibrillator and who will most likely undergo induction of ventricular arrhythmia as part of the procedure

Exclusion criteria: :

 Cardiac Arrest:

 Cardiac arrest and a known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.

 CNS infection

 Skull defects and scalp diseases that are not amenable to standard EEG testing

 ICD patients:

 Known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.

 CNS infection

 Skull defects and scalp diseases that are not amenable to standard EEG testing


Seattle Cardiorenal Remote Ischemic Preconditioning Trial

Summary: Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.
Inclusion criteria: inclusion criteria:

 Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass

Exclusion criteria: :

 Any contraindication to compression of lower extremity/extremities Body weight <2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery

['Congenital Heart Disease', 'Cardiopulmonary Bypass', 'Myocardial Injury', 'Acute Kidney Injury', 'Acute Lung Injury']

Congenital Heart Disease
Cardiopulmonary Bypass
Myocardial Injury
Acute Kidney Injury
Acute Lung Injury


Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus

Summary: This is a study to determine if people with Lupus have weak bones.~Test which is a better method for detecting bone changes:~Dual energy X-ray absorptiometry (DXA)~Single energy quantitative computed tomography (SEQCT)~Evaluate whether weak bones are associated with things like medications or amount of fat and muscle.
Inclusion criteria: inclusion criteria:

 Systemic Lupus Erythematosus subjects 4/11 of the American College of Rheumatology criteria for SLE (23), age less than 22 years.

Exclusion criteria: :

 Neonatal SLE or drug-induced Systemic Lupus Erythematosus

 Subjects who are pregnant, and subjects weighing over 300 pounds, as the densitometry techniques are not reliable above this weight.

 Subjects receiving calcium or vitamin D supplementation will not be excluded but this information will be recorded and evaluated further in the dietary/nutritional assessment.


Sensory Function in Idiopathic Voice Disorders

Summary: This research study is designed to improve understanding about voice disorders that are due to uncontrolled muscle contractions affecting the voice box. The type of voice disorder depends on which muscles of the voice box are involved. Abductor spasmodic dysphonia may lead to a weak voice. Adductor spasmodic dysphonia may result in a strangled voice. Muscular tension dysphonia may lead to a strained voice. Some of the major goals of the study are to;~understand how sensation from the voice box affects voice and speech production~develop better ways to diagnose sensation abnormalities affecting the voice box~determine if patients with voice disorders differ from persons without voice disorders in the way they respond to sensory information from their voice box~Researchers believe that by understanding better how sensations of the voice box are presented and how the muscles in the larynx respond to those sensations they will be able to develop better treatments for patients suffering from voice disorders. ...
Inclusion criteria: inclusion criteria - Normal Volunteers:

 Normal volunteers between the ages of 20 and 80 years of age will be selected after a screening examination.

 Subjects will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by an otolaryngologist.

 None of the subjects included for study will have a reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm.

Exclusion criteria:  - Normal Volunteers:

 Any patient with a history of airway obstruction will be excluded from the study.

 No smokers or tobacco users will be included in the study.

 Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation.

 Any individual with: 1) an implant or surgical clip - implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular implant, aneurysm clip, artificial heart valve, insulin pump, orthopedic pins or prosthesis: 2) a foreign body - metal shavings, shrapnel, orthodontic braces, tattoos or permanent eye liner; and/or, 3) any other implanted device or foreign body not listed above that is possibly ferromagnetic will also be excluded from study seven because of contraindications for magnetic resonance imaging.

 inclusion criteria - Patients with Spasmodic Dysphonia:

 Symptoms present during speech and not apparent at rest.

 Symptoms less evident during whisper, singing or falsetto.

 Symptoms become worse with prolonged speaking, practice or anxiety.

 Reflexive and emotional aspects of voice function are unaffected, such as coughing, laughter or crying.

['Phonation Disorder', 'Spastic Dysphonia', 'Voice Disorder']

Phonation Disorder
Spastic Dysphonia
Voice Disorder


Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia

Summary: The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).
Inclusion criteria: inclusion criteria:

 Fertile women between age of 20 and 49

 Patients with cervical intraepithelial neoplasia 1(CIN1)

 HPV(Human Papilloma Virus) positive(+)

 White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10^6/L

 AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal

 Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray

 Be informed of the nature of the study and will give written informed consent

Exclusion criteria: :

 Malignant tumor in any organ other than cervical intraepithelial neoplasia

 Active liver disease, immune disorder and severe renal failure

 Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded)

 Diagnosed diabetes

 Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc)

 Pregnancy and breastfeeding

 Registered in other clinical trials

 Patients whom the investigator considers inappropriate to participate in the study


The ACE Follow-up Study

Summary: The Articulating Circular Endoscopic (ACE) Stapler is an investigational system using endoscopic guidance to trans-orally place plications in the stomach in obese subjects to reduce volume and expansion of the fundus and greater curve to abate hunger as part of a supervised weight reduction program.~The primary objective of this study is to perform an evaluation of the safety of the plication procedure.~The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of obesity over a 24 month follow-up period.
Inclusion criteria: inclusion criteria:

 Subject, male or female, is age 18 to 50 years of age.

 Subject must be able to understand and be willing to sign an informed consent document.

 Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.

 Subject has a BMI of 40 - 45 or 30 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus.

 Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.

 Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.

 Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.

 Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline.

 Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial.

Exclusion criteria: :

 Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.

 Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years.

 Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure.

 Subject has a history or is diagnosed with eating disorders.

 Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure.

 Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.

 Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.

 Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility.

 Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where plications are to be placed.


Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study

Summary: This is an observational study of composite indices, including the CLARA (CLinical ARthritis Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy in order to evaluate clinical remission and low disease activity. Data will be collected only from patients providing informed consent. In this study we aimed to assess the psychometric properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this index would facilitate rapid and easy RA activity assessment in daily routine.
Inclusion criteria: inclusion criteria:

 Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) criteria and in accordance with local guidelines.

 Patients eligible to anti-TNF therapy

 Patients naïve to anti-TNFa drugs

 Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method [Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form

Exclusion criteria: :

 Patients with tumors

 Patients already included in clinical trials


Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

Summary: The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.
Inclusion criteria: inclusion criteria:

 Any adult patient who meets criteria and is scheduled for tonsillectomy

Exclusion criteria: :

 Any patient with prior use of acupuncture

 Individuals under age 18

 Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy,

 Patients with a known personal or family history of a bleeding disorder will be excluded.

 Patients with a history of kidney or liver problems will also be excluded.

 Patients found to be pregnant will be excluded from participation.

 Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.

['Recurrent Tonsillitis', 'Peritonsillar Abscess', 'Obstructive Sleep Apnea']

Recurrent Tonsillitis
Peritonsillar Abscess
Obstructive Sleep Apnea


Pap Smear Research Study

Summary: The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear.
Inclusion criteria: inclusion criteria:

 18 years and older

 Ability to speak and clearly understand English

 Female patients

Exclusion criteria: :

 No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.)

 Women who have had Pap smears within the previous 10 months

 Women under the age of 18.

 Women who are pregnant.

 Inability to give informed consent in English

['Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)']


Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

Summary: Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
Inclusion criteria: inclusion criteria:

 Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:

 Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers

 Greater than 20% sustained rise in beta HCG titer over two consecutive weeks

 Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum)

 Histologically proven nonmetastatic choriocarcinoma

 Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm)

 WHO score 0-6 (not including blood group or CT lung)

 No histologically confirmed placental site pseudotumor

 Must have undergone at least 1 uterine curettage

 Previously untreated disease

 Performance status - GOG 0-2

 WBC at least 3,000/mm^3

 Granulocyte count at least 1,500/mm^3

 Platelet count at least 100,000/mm^3

 Bilirubin no greater than 1.5 times upper limit of normal (ULN)

 SGPT and SGOT no greater than 3 times ULN

 Alkaline phosphatase no greater than 3 times ULN

 No significant prior abnormal hepatic function

 Creatinine no greater than 2.0 mg/dL

 No significant prior abnormal renal function

 Not pregnant or nursing

 Fertile patients must use effective contraception during and for one year after study entry

 No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer

 No prior chemotherapy for gestational trophoblastic neoplasia

 No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor
Exclusion criteria:

['Good Prognosis Metastatic Gestational Trophoblastic Tumor', 'Hydatidiform Mole', 'Non-Metastatic Gestational Trophoblastic Tumor', 'Uterine Corpus Choriocarcinoma']