Hypnotic Medications and Memory: Effect of Drug Exposure During the Night

Summary: The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.
Inclusion criteria: inclusion criteria:

 18 to 50 years of age

 no sleep complaints or problems

 good sleep quality per questionnaire

 sufficient time in bed each night

Exclusion criteria: :

 any clinically significant unstable medical condition

 recent psychiatric disorder

 prior diagnosis or symptoms of a sleep disorder

 recent history of substance abuse

 recent use of prescription hypnotic medication or over-the-counter sleep aid

 recent use of psychotropic medication

 history of adverse reaction to benzodiazepines

 body mass index > 36

 currently pregnant or nursing

 currently working rotating or night shift

 consumption of > 700 mg per day of xanthine-containing food or beverages

 consumption of > 14 units of alcohol per week

 smoke > 1 pack of cigarettes per day, use of chewing tobacco more than 3 times per day, or unable to refrain from smoking or chewing without distress or discomfort while in the sleep laboratory

['zaleplon', 'zolpidem extended release', 'bedtime placebo', 'middle of the night placebo']

zaleplon
zolpidem extended release
bedtime placebo
middle of the night placebo


Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow Transplantation

Summary: We are approaching you to participate in this study because you are taking Palifermin and the purpose of this study is to describe the effect of Palifermin on skin growth found on the body. Palifermin is a new synthetic growth factor (encourages skin cells to grow) specifically designed to protect the areas of the body (mouth and upper digestive tract) that are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these areas to grow and therefore protects patients from some serious side effects of chemotherapy. These include mucositis or inflammation of the lining of the mouth and other organs resulting in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract.~Skin cells are also known to respond to these types of growth factors like Palifermin, but unfortunately no studies have been done that look specifically at the effect of this drug on pre-existing skin lesions or the development of new skin lesions. We will be asking you if you have noticed any change in moles or other skin lesions that you have, and if you have noticed any new lesions. We will also be doing a full physical examination of the skin at regular intervals during the study to document the appearance of any new lesions or change in pre-existing ones.
Inclusion criteria: inclusion criteria: receiving bone marrow transplant -

Exclusion criteria: : not receiving other growth factors

 -

: not receiving other growth factors

 -


Diurnal Variation in Hypertensive Stroke Patients

Summary: This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP).
Inclusion criteria: inclusion criteria:

 aged 35 to 85 years

 hypertensive patients who had an ischemic stroke

Exclusion criteria: :

 patients aged below 35 years or above 86 years;

 patients who had a hemorrhagic stroke;

 patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit;

 patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions

 patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics;

 (7) patients with a severe stroke (NIH stroke scale > 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT ≥ 100); (10) patients with severely impaired renal function (serum creatinine ≥ 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs


Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)

Summary: The purpose of this clinical trial is to determine if Domperidone in a dose of 40 mg daily can prevent worsening of walking ability in people secondary progressive MS. The number of participants in this study will be 62. A maximum of 75 people with secondary progressive MS will be included. Each patient will be followed for 12 months from inclusion. Domperidone is a medication which has been shown to increase levels of the hormone prolactin. The best understood function of prolactin is the stimulation of milk production in women after delivery. However, the increase in prolactin levels seen in patients treated with standard doses of Domperidone (in doses of up to 80mg per day) usually does not lead to clinical symptoms. Prolactin has been shown to improve myelin repair in mice. Domperidone therefore may also improve myelin repair in people with MS. Domperidone is currently approved in Canada to treat slow moving bowels and nausea, for instance in patients with Parkinson's Disease or Diabetes Mellitus, where too slowly moving bowels can cause constipation. Domperidone is available as a tablet that is usually taken four times per day. Doses up to 80mg per day may be used but we estimate that a dose of only 40mg daily will be needed to stimulate myelin repair. Domperidone is usually well tolerated.
Inclusion criteria: inclusion criteria:

 written informed consent obtained

 with Multiple Sclerosis, and with secondary progressive disease course

 screening Expanded Disability Status Scale (EDSS) score between 4.0 and 6.5 inclusive

 screening timed 25 foot walk (average of two trials) lof 9 seconds or more

Exclusion criteria: :

 Long QT interval, defined as corrected QT interval of more than 470 msec in men and more than 450 msec in women on baseline ECG

 Patients with known long-QT syndrome

 Patients with known ventricular arrhythmia

 Patients with a known electrolyte disturbance

 Patients undergoing treatment with drugs that increase the QTc interval

 Patients undergoing treatment with drugs that inhibit CYP3A4, in particular: Ketoconazole, Fluconazole, Erythromycin, Clarithromycin, Ritonavir

 Patients with a history of breast cancer or carcinoma in situ

 Patients with known renal insufficiency

 Patients with known allergy or other intolerability to domperidone

 Patients currently using Fampridine or 4-aminopyridine

 Patients planning to start Fampridine or 4-aminopyridine during the study period

 Patients planning to start Baclofen or Tizanidine during the duration of the study

 Patients planning to increase or decrease their dose of Baclofen or Tizanidine during the study period

 Patients planning to receive treatment with Botulinum toxin in the leg muscles during the duration of the study

 Patients with a significiant hepatic impairment

 Patients with a prolactinoma

 Patients in whom gastrointestinal stimulation could be dangerous

 Patients using MAO inhibitors

 Patients with a history of breast cancer

 Pregnant or breast-feeding women

['Multiple Sclerosis, Secondary Progressive']

Multiple Sclerosis
Secondary Progressive


IPg2 Study: Left-sided Lung Isolation

Summary: Lung isolation is primordial in thoracic surgery. To achieve it, two techniques are used: the double lumen tube (DLT) and the bronchial blocker (BB). Left-sided DLT (L-DLT) is use by the majority of anesthesiologists for both left and right thoracic surgeries. Standard right-sided DLT (Rs-DLT) is rarely use since it is dif¬ficult to properly position it and that there is a risk of misalignment between the lateral orifice of the tube and the origin of the right upper lobe (RUL) bron¬chus. In 2007, the investigators have published results suggesting enlarging the Rs-DLT's lateral orifice. The modified R-DLT (Rm-DLT) was more frequently in an adequate position: 77% vs 37% of patients (p = 0.0121), and easier to reposition: 97% vs 74% of patients (p= 0.0109) in comparison to the standard R-DLT group. The data suggest the superiority of the Rm-DLT compared to Rs-DLT for optimal positioning to facilitate one-lung ventilation (OLV) during thoracic surgery. It is believed that DLT tend to provide quicker and better quality of lung collapse than BB. In 2013, investigators have demonstrated an equivalent quality of lung collapse (LC) between L-DLT and BB used with two apnea periods when initiating OLV. Complementary analysis showed a significative difference to obtain complete LC (CLC) between L-DLT for left thoracoscopy and L-DLT for right thoracoscopy and BB in right or left surgery. The investigator hypothesis is that, when using L-DLT for left video-assisted thoracoscopic surgery (VATS), LC of the isolated lung will be slower and of poorer quality compare to the use of the Rm-DLT. The primary objective is to compare the delay between pleural opening (PO) and CLC in left VATS when using three lung isolation devices: 1) L-DLT and 2) Rm-DLT. Secondary objectives are: 1) to evaluate quality of LC, 2) to evaluate the level of obstruction of the lumen of the left bronchus, 3) to evaluate the quality of OLV (PaO2) 4) To collect blind surgeon's opinion about de device used and 5) to measure the delay between OLV and PO for evaluating the role of absorption atelectasis in obtaining CLC. After obtaining IRB approval, the investigators propose a study of 40 patients undergoing an elective left VATS at IUCPQ involving one lung ventilation. They will have to be 21 years or more, to read, understand and sign an informed consent at their pre-operative evaluation. This study will be prospective, randomized, and blind to thoracic surgeons.
Inclusion criteria: inclusion criteria:

 signed informed consent

 elective left video-assisted thoracoscopy

 one lung ventilation

Exclusion criteria: :

 Anticipated difficult mask ventilation or intubation

 tracheal or high bronchial origin of the right upper lobe main bronchus

 severe COPD or asthma

 pleural disease

 previous left thoracic surgery

 chest radiotherapy

 chimiotherapy

 significant systemic co-morbidity

 active or chronic pulmonary infection

 fibrosis, other interstitial diseases

 endobronchial mass

 tracheostomy

 severe desaturation in the peroperative period

 any clinical situation precluding the use of an isolation device

['Video-assisted Thoracoscopic Surgery (VATS)', 'One-lung Ventilation']


Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients

Summary: The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma, myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug will also be studied. Another goal of the study is to see how certain cytokines change while patients undergo chemotherapy or hormonal treatment.
Inclusion criteria: inclusion criteria:

 Patient diagnosed with breast, gastrointestinal, lymphoma, myeloma or lung cancer undergoing chemotherapy or hormonal treatment

 Patient is > or = 18 years of age

 Patient has Brief Fatigue Inventory fatigue worst score of > or = 4 at baseline

 Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2 at baseline

 Patient has a life expectancy > or = 6 months from the start of the study

 Patient is using acceptable birth control methods. Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Medically acceptable methods of contraception include abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization

 Patient must speak and understand English

 Patient has provided written informed consent to participate in the study prior to enrollment to the study

Exclusion criteria: :

 History of hypersensitivity reaction to methylphenidate

 History of or current seizure disorder, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, tension or agitation

 History of clinically significant cardiac disease.

 Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently (defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg

 History of fibromyalgia

 Use of alcohol while participating in the study

 Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential (see protocol for criteria)

 Moderate to severe depression (> or = 20 on Beck Depression Index II)

 If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days

 Currently taking psychostimulants (including appetite suppressants), monoamine oxidase (MAO) inhibitors, anticoagulant or anticonvulsant therapy

 Current use of corticosteroids, medications, or stimulants (i.e., vivarin) used to improve fatigue symptoms

 Use of an investigational medication within the past month

 Current use of the following herbals or supplements for fatigue relief (DHEA, SAME, ginkgo, ginseng, St. John's Wort (including DHEA, SAME, ginkgo, ginseng, St. John's Wort, metabolite, effedrin, basil, citronella, fennel, horseradish roots, lavender flowers, lemon verbena, marjoram, mint, nettle, pine needles, rosemary, sage, savory, thyme, bay, cayenne pepper, cinnamon, eucalyptus, hyssop, myrrh, oregano, peppermint, ginseng, green, black or Chinese tea, ephedra (aka - ma-huang), popotillo, and Mormon tea)

 Any coexisting medical condition or are taking any concomitant medication that is likely to interfere with the safe administration of methylphenidate

 Patients who start epoetin within 30 days prior to enrollment

 Patients who start taking epoetin during the first week of the study

 Hemoglobin < 8.0 gm/dl

 Patients with a thyroid-stimulating hormone (TSH) value > or = 1.5 times the upper limit of normal (ULN)

 Albumin value 50% lower than the lower limit of normal

 Evidence of hepatic impairment [total bilirubin > or = 2.5 times ULN (normal range of 0 - 1.0 mg/dl, serum glutamate pyruvate transaminase (SGPT) > or = 2.5 times ULN)]

 Evidence of renal impairment (serum creatinine > 2.5 times ULN, normal range of 0.8 - 1.5 mg/dl)

 A severe narrowing (pathological or iatrogenic), obstruction of the gastrointestinal tract, or gastrointestinal malabsorption

 If taking anxiolytics, and/or hypnotics, no changes in dose and/or no start of new course of treatment in the last 30 days

 Patients with nausea, vomiting, or diarrhea of Common Toxicity Criteria for Adverse Effects (CTCAE) grade III or higher

 If taking anticonvulsants for sensory neuropathy (Gabapentin or Pregabalin), no changes in dose and/or no start of new course of treatment in the last 30 days

 History of severe headaches within 30 days prior to enrollment

['Breast Cancer', 'Fatigue', 'Gastrointestinal Cancer']

Breast Cancer
Fatigue
Gastrointestinal Cancer


Oropharyngeal Function After Radiotherapy With IMRT

Summary: This project defines the effect on swallowing of intensity modulation during radiotherapy in an organ preservation treatment involving chemoradiation for 125 oral, laryngeal, and pharyngeal cancer patients with previously untreated Stage III or IV disease and to identify optimum treatment strategies. The specific aims are: 1) define the physiologic effects of chemoradiotherapy with IMRT to various sites in the upper aerodigestive/vocal tract including the cervical esophagus and the rate at which patients return to oral intake; 2) document the acute toxicities, late complications, locoregional failure and survival, and the relationship between fibrosis rating and the measure of laryngeal elevation; 3) determine whether the patient's swallowing mechanism can compensate for physiologic deficits in swallowing by introduction of interventions (postural changes, voluntary swallow maneuvers, several bolus volumes); 4) determine whether time to return to oral intake, effects of swallow maneuvers and/or volume, presence of an esophageal stricture and the duration of success of dilatation depends on radiation dose volume to specific structures in the head and neck; 5) define the relationship of tongue base pressure to development of esophageal stricture. Patients will be accrued from Northwestern University and University of Chicago. Effects are defined in terms of swallowing function, morbidity, toxicity and survival. Other outcome measures are the maintenance of voluntary control (flexibility) of the oropharyngeal region as indicated by the ability to correctly produce swallow maneuvers; and positive changes in cricopharyngeal opening duration with normal bolus volume shifts. Patients will be studied pretreatment, and at 1 month, 3 months, 6 months, 12 months, and 24 months post completion of chemoradiation. At each assessment, patients will receive a videofluoroscopic assessment of swallowing utilizing a standard protocol, assessment of xerostomia, mucositis, and fibrosis as well as assessment of disease status and quality of life scales. Head and neck cancer is a severe problem that affects public health. Most current treatments are a combination of radiotherapy with chemotherapy, which can result in severe swallowing problems which may make patients unwilling to accept this type of treatment. This project attempts to quantify the swallow problems associated with this specific treatment and the effects of interventions for these swallow problems.
Inclusion criteria: inclusion criteria:

 The target population for this study is 125 patients with stages III or IV squamous cell lesions of the oral cavity, oropharynx, pharynx or larynx, or unknown primary.

Exclusion criteria: :

 No patient will have had prior treatment for head and neck cancer or any otolaryngologic or neurologic disorder affecting swallow and no preexisting swallowing disorder.


Evaluation of Combined Use of ITN's and Insect Repellents Against Malaria

Summary: Insecticide Treated Nets (ITN's) offer good protection against malaria in Africa where the vector mosquitoes feed indoors late at night. However, in other parts of the world like South America, vectors feed earlier in the evening before people go to bed. In such cases it may be necessary to use alternative treatments in the evening to supplement the efficacy of ITN's. This study compares 2 matched groups of households in the Bolivian Amazon. One group will be given ITN's plus a plant-based insect repellent in the evening, the other has ITN's plus a placebo lotion. Households are monitored over a full malaria season to record numbers of malaria cases.
Inclusion criteria: inclusion criteria:

 Written informed consent.

 Available for 4 x monthly follow ups.

 5 or more individuals in household.

Exclusion criteria: :

 Allergy to repellents / plants.

 Malaria positive at baseline.

['Insect Repellent plus Insecticide Treated Net']


Two-Dose Methotrexate for Ectopic Pregnancy

Summary: This study examines the safety and acceptability of a novel two dose regimen of methotrexate to treat ectopic pregnancy.
Inclusion criteria: inclusion criteria:

 Confirmed diagnosis of ectopic pregnancy via

 D&E without products of conception identified on frozen pathology or

 VABRA without products of conception identified with pathologic evaluation or

 Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole

 the subject is hemodynamically stable without signs of hemoperitoneum

 laparoscopy has not been performed

 the subject is able to return for frequent follow-up care

 normal renal and liver function have been documented within 2 days

 normal white blood count and platelet count have been documented as per laboratory standard

 normal chest x-ray was obtained if the subject has a history of pulmonary disease

 no history of allergy or sensitivity to methotrexate or any component of its formulation

Exclusion criteria: :

 breastfeeding

 laboratory evidence of immunodeficiency

 alcoholism or chronic liver disease

 the concomitant use of non-steroidal anti-inflammatory drugs

 blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia

 active pulmonary disease

 hepatic, renal, or hematological dysfunction

 adnexal mass > or = 3.5 cm

 presence of fetal cardiac motion

 active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction

 subjects unable or unwilling to comply with study procedures or illiterate


Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents

Summary: Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has potential in preventing and treating adolescent depression. The purpose of this study was to compare the short- and long-term effectiveness of CBT alone and CBT plus parental education for community-based adolescents at risk for depression and suicide in Taiwan. It is hypothesized that the CBT alone and CBT with parental education group are more effective than the control group.
Inclusion criteria: inclusion criteria:

 willing to participate group assignment and grant consents

Exclusion criteria: :

 unwilling to participate potential group activity and grant consents

 severe physical or psychiatric disorders

['CBT plus parent education', 'CBT alone']

['Community Adolescents at Risk for Depression and Suicide']


Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus.~PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus.
Inclusion criteria: DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0

 PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix

 PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Exclusion criteria:

['cisplatin', 'fluorouracil', 'conventional surgery']

cisplatin
fluorouracil
conventional surgery


Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache

Summary: The primary aim of the present trial is to study the effect of daily vitamin D supplementation on muscular power and force among non-western immigrants living in Oslo, Norway, and secondarily to study the effect of musculoskeletal pain and headache.~The investigators have also prespecified a number of additional research questions about anemia, metabolism and bone turnover, inflammation, diabetes, lipids, itching and kidney function, which because of multiple comparisons should be interpreted with caution unless the statistical evidence for an effect is very strong.
Inclusion criteria: inclusion criteria:

 Male and female between 18 - 50 years old

 Immigrants with background from Middle East, Africa and South Asia.

Exclusion criteria: :

 Daily use of vitamin D supplementation and frequently use of artificial UV light exposure.

 Pregnancy

 Malabsorptive disorders

 Fracture in the leg /arm within the preceding 6 months. Known osteoporosis

 Tuberculosis, sarcoidosis, cancer, kidney dysfunction, liver dysfunction and history of kidney stone.

 Regular use of medication that interfere with vitamin D/bone metabolism, such as glucocorticoids, diuretics, lithium, antiepileptics, bisphosphonates,

 Regular use of strong pain killers.

 Medication for diabetes


Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone

Summary: The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.
Inclusion criteria: inclusion criteria:

 participants must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit (arthritis)

 Stable dose of prednisone (<30mg) for at least one month

Exclusion criteria: :

 participants experiencing an active lupus flare in the kidney or central nervous systems

 Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study

 participants with active viral or bacterial infections

 participants with any other autoimmune disease as a main diagnosis

 Prior treatment with rituximab

['Abatacept', 'Placebo', 'Prednisone', 'Abatacept']


The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients

Summary: The investigators want to evaluate the burden of peripheral artery occlusion disease in Taiwan peritoneal dialysis (PD) patients by using ankle-brachial pressure index (ABI) and toe-brachial pressure index (TBI). Furthermore, the investigators hope to demonstrate the possible casual factors of peripheral artery occlusion disease (PAOD) in PD patients.
Inclusion criteria: inclusion criteria:

 Receive stable peritoneal dialysis patients for more than 3 months

Exclusion criteria: :

 Active infection, malignancy and recent hospitalization


Prevention of Bacteremia Induced by Debridement of Pressure Ulcer

Summary: The purpose of this study is to analyse bacteremia induced by debridement of pressure ulcers in patients in the complex nursing department.
Inclusion criteria: inclusion criteria:

 Patient in the complex nursing department

 With contaminated pressure ulcers

 Going to have a debridement procedure

Exclusion criteria: :

 Penicillin sensitivity

 Bacteremia that does not react to the antibiotic treatment


Neurogenic Inflammation in Diabetes

Summary: Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot fractures. After these fractures have healed, the shape of the foot can be dramatically altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves are important in regulating the inflammatory response. This study aims to investigate whether the inflammatory response is different in patients with polyneuropathy with and without a history of Charcot's disease.
Inclusion criteria: inclusion criteria:

 Patients with type 2 diabetes with and without polyneuropathy.

 Patients with type 2 diabetes with a history of Charcot's disease.

 Healthy controls.

 Signed informed consent.

Exclusion criteria: :

 Peripheral arterial disease: toe pressure < 70 mm Hg and/or transcutaneous oxygen tension < 40 mm Hg and/or claudication.

 Renal insufficiency: MDRD creatinin clearance < 30 ml/min.

 Systemic disease such as vasculitis or rheumatoid arthritis.

 Malignancy.

 (Diabetic) foot ulcer.

 Gout.

 Bacterial infection of an extremity.

 Skin condition of the dorsal aspect of the foot or the medial side of the upper arm.

 Bleeding disorder such as hemophilia.

 Use of medication for asthma.

 Impaired immunity such as in HIV/AIDS.

 Capillary blood glucose < 3 mmol/l or > 20 mmol/l at the time of the study.

 Peripheral oedema.

 Vaccination in the two months prior to study inclusion.

 Chemotherapy or radiation therapy in the twelve months prior to study inclusion.

 Surgery in the two months prior to study inclusion.

 Previous adverse reaction to Candida albicans antigen.

 Acute infection at the time of the study or in the month prior to study inclusion.

 Transfusion in the two months prior to study inclusion.

 Use of immunosuppressants in the two months prior to study inclusion.

 Pregnancy or breastfeeding.

['Intracutaneous injection of Candida albicans antigen.', 'Temperature measurement.']

['Diabetes Mellitus', 'Polyneuropathies', 'Arthropathy, Neurogenic']

Diabetes Mellitus
Polyneuropathies
Arthropathy
Neurogenic


Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures

Summary: The aim of the study is to test the hypothesis that patients older than 60 years with a femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior minimal-invasive approach as compared to a standard lateral Hardinge approach show better functional recovery postoperatively as measured by the Timed up and go-test (TUG).
Inclusion criteria: inclusion criteria:

 Age of 60 years or more, ambulatory with/without walking aids before trauma

 Femoral neck fracture eligible for hemi-arthroplasty in accordance with the algorithm for femoral neck fracture patients used at the University hospital Basel

 Informed consent

Exclusion criteria: :

 Refusal of consent by the patient or legal representatives to participate in the study

 More than one fracture

 Suspicion of a pathological fracture in the context of known or unknown malignancy

 Previous surgery of the proximal femur on the same side

 Follow-up not possible (Tourist etc.)

['Trans-gluteal approach, CLAS', 'Anterior minimal invasive approach, AMIS']

Trans-gluteal approach
CLAS
Anterior minimal invasive approach
AMIS


Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Summary: To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.
Inclusion criteria: inclusion criteria:

 Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.

 May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.

 Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Exclusion criteria: :

 History of substance abuse or dependence within the past year, excluding nicotine and caffeine.

 Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study.

 Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.

 Treatment with fluoxetine within 30 days of starting the study.

 Unstable blood sugar control and uncontrolled or poorly controlled hypertension.


Safety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Congestive Heart Failure

Summary: The purpose of this study is to compare the safety of Pioglitazone, once daily (QD), to Glyburide in Type 2 Diabetes Subjects with Mild to Moderate Congestive Heart Failure
Inclusion criteria: inclusion criteria

 Females of childbearing potential must be using appropriate birth during the entire duration of the study or must be surgically sterile.

 Subjects with a clear diagnosis of type 2 diabetes mellitus using diagnostic criteria of the American Diabetes Association who have been taking a sulfonylurea and/or insulin for at least 30 days prior to Visit 1 or who have been withdrawn from metformin therapy, during the 30 days prior to Visit 1, due to congestive heart failure.

 Subjects with a clinical diagnosis of congestive heart failure, New York Heart Association Class II or early Class III. Subjects should not previously have been in Class IV heart failure.

 Diagnosis of left ventricular congestive heart failure as evidenced by a left ventricular ejection fraction less than 40% at screening based on an echocardiogram.

 Subjects who have demonstrated the need for oral hypoglycemic agents and have participated in dietary counseling.

 Glycosylated hemoglobin greater than 7.0% at screening.

 Subjects on optimal therapy for congestive heart failure. Medication doses should be stable for at least two weeks prior to randomization.

Exclusion criteria:

 Naïve to antidiabetic therapy.

 Within the past three months were treated with rosiglitazone, pioglitazone HCl, or troglitazone or those previously treated with rosiglitazone, pioglitazone HCl, or troglitazone but discontinued from therapy due to lack of efficacy or clinical or laboratory signs of intolerance.

 Type 1 (insulin-dependent) diabetes mellitus or a history of ketoacidosis.

 Has taken any other investigational drug during the 30 days prior to Visit 1 or who will receive such a drug during the timeframe of this study.

 History of chronic alcoholism or drug abuse during the six months prior to the study.

 Has had any of the following within three months prior to Visit 1: myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, or documented cerebrovascular accident that in the investigator's opinion would warrant exclusion from the study.

 Abdominal, thoracic, or vascular surgery during the three months prior to Visit 1 that in the investigator's opinion would warrant exclusion from the study.

 Subjects with a planned surgical or catheterization intervention within the six months following Visit 1.

 Subjects awaiting cardiac transplantation.

 Intercurrent illness severe enough to require hospitalization during the three weeks prior to Visit 1.

 Body mass index greater than 48 kg/m2 as calculated by [Weight (kg)/Height (m)2].

 Anemia having a hemoglobin less than 10.5 g/dL for males and less than 10 g/dL for females.

 Thyroid stimulating hormone greater than 3.5 mU/L or less than 0.3 mU/L. The thyroid stimulating hormone can be repeated at two months. The subject is eligible if the screening thyroid stimulating hormone is elevated, and the repeat value at two months is less than 3.5 mU/L.

 Triglyceride level greater than 500 mg/dL.

 Clinical evidence of active liver disease or alanine transaminase levels greater than 1.5 times the upper limit of normal.

 Serum creatinine greater than 2.0 mg/dL for males and greater than 1.8 mg/dL for females or urinalysis protein (albumin) excretion greater than 2 plus on Combistix or equivalent (if elevated, may be re-screened in one month).

 Unstable coronary syndromes which in the opinion of the investigator would warrant exclusion from the study.

 Systolic blood pressure of greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg.

 Serious uncontrolled cardiac rhythm disturbances which in the opinion of the investigator would warrant exclusion from the study.

 Symptomatic orthostatic hypotension or systolic blood pressure less than 90 mm/Hg.

 Severe, advanced peripheral vascular disease (limb threatening ischemia) or claudication resulting in the inability to walk greater than 1 block or to climb 10 stairs without interruption.

 Lower extremity amputation.

 Any other serious disease or condition at screening or at randomization which might affect life-expectancy or make it difficult to successfully manage and follow the subjects according to the protocol.

 Unexplained clinically significant findings on chest x-ray.


Treatment Trial of Subclinical Hypothyroidism in Down Syndrome

Summary: The purpose of this research study is to learn about the effects of treating subclinical hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will improve cardiometabolic health and quality of life.
Inclusion criteria: inclusion criteria:

 Males and females, ages 8 - 20 years

 Diagnosis of Down syndrome

 Subclinical hypothyroidism: TSH level between 5 - 10 mIU/L, normal T4

 Parental/guardian permission (informed consent) and if appropriate, child assent

 Females who are at least 11 years of age or who are menarchal must have a negative urine/serum pregnancy test

 Committed to adherence to levothyroxine treatment and study completion

Exclusion criteria: :

 Pregnancy

 Type 1/Type 2 diabetes

 Chronic medical conditions or medication use that can affect growth, nutrition, blood glucose, insulin secretion, or thyroid function (such as lithium or certain seizure medications)

 Current use of levothyroxine or anti-thyroid hormone

 Cyanotic congenital heart disease, or pulmonary hypertension (as described by last echo report in subjects with CHD), or congenital heart disease considered medically unstable by the study cardiologists

['Down Syndrome', 'Subclinical Hypothyroidism']

Down Syndrome
Subclinical Hypothyroidism


Prospective Randomized Controlled Trial Comparing Water and Air Colonoscopy in a Community Based Setting

Summary: The purpose of this study is to determine if screening colonoscopy performed on adults with the water exchange method, as opposed to the air method, will have a higher adenoma detection rate.
Inclusion criteria: inclusion criteria:

 Age ≥50 years

 Individuals able to provide informed consent

 Individuals presenting for average-risk colorectal cancer screening by colonoscopy

 Individuals presenting for surveillance of adenomatous/sessile serrated colon polyps as per the US multi-society taskforce on colorectal cancer

Exclusion criteria: :

 Patients who decline to participate

 Prior partial or complete colectomy

 Patients with history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)

 Patients with prior history of colorectal cancer

 Patients with history of screening colonoscopy within the past 10 years

 Patients with history of familial polyposis syndromes (Familial Adenomatous Polyposis, Lynch Syndrome)

['Water Exchange Colonoscopy', 'Air Colonoscopy']

Water Exchange Colonoscopy
Air Colonoscopy

['Colon Cancer', 'Tubular Adenoma', 'Hyperplastic Polyp']

Colon Cancer
Tubular Adenoma
Hyperplastic Polyp


Trial of a Tailored Message Program to Implement CHF Guidelines

Summary: Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial.
Inclusion criteria: inclusion criteria:

 EF <40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English.

Exclusion criteria: :

['CHF Self-management Education (Web-based Education)']


Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

Summary: The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.~Primary Objective~- To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only).~Secondary Objectives:~If the primary objective of non-inferiority was achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 and CYD30 trials.~To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants.~To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 participants) and immediately prior to booster or placebo injection in all participants.~To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post booster or placebo injection in all participants.~To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.
Inclusion criteria: inclusion criteria:

 Had been identified as a potential participant by the Sponsor and is included in the list provided to the Investigator (i.e., aged 9 to 16 years on the day of first vaccination of CYD dengue vaccine in CYD13/CYD30 and has a post-dose 3 serum sample available [at least 400 microliters of serum]).

 Participants were in good health, based on medical history and physical examination.

 Assent form or informed consent form (ICF) had been signed and dated by the participant (based on local regulations), and ICF had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).

 Participant and parent(s)/legally acceptable representative(s) attended all scheduled visits and complied with all trial procedures.

Exclusion criteria: :

 Participant who received any other dengue vaccination that was not part of the CYD13 or CYD30 trials.

 Participant was pregnant, or lactating, or of childbearing potential (to be considered of non childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).

 Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.

 Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination.

 Receipt of immune globulins, blood or blood-derived products in the past 3 months.

 Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

 Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.

 Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.

 Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.

 Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

 Current alcohol abuse or drug addiction.

 Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.

 Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

['CYD Dengue Vaccine (5-dose formulation)', 'Placebo, NaCl 0.9%']

CYD Dengue Vaccine (5-dose formulation)
Placebo
NaCl 0.9%

['Dengue Fever', 'Dengue Hemorrhagic Fever']


¡Si, Yo Puedo Control Mi Diabetes!: A Diabetes Self-management Education Program for Hispanic/Latinos

Summary: The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi Diabetes! (Yo Puedo) diabetes self-management education program.
Inclusion criteria: inclusion criteria: Self-identification as Hispanic/Latino, over the age of 18 years of age, diagnosis of type 2 diabetes and willingness to participate in the diabetes self-management education class.

Exclusion criteria: : non-diabetic persons, non English-speaking Hispanic/Latinos with type 2 diabetes

 -

['Type 2 Diabetes, Hispanic/Latinos, Diabetes Self-management Education']

Type 2 Diabetes
Hispanic/Latinos
Diabetes Self-management Education


Renal Effects of Levosimendan in Cardiac Surgery Patients

Summary: Recent experimental and clinical data suggest a benefit of levosimendan on the kidney function. Therefore, this retrospective, single center, matched-pairs analysis aimed to investigate whether administration of levosimendan was associated with improved renal function in cardiac surgery patients.
Inclusion criteria: inclusion criteria:

 Patients undergoing cardiac surgery (OPS 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital

Exclusion criteria: :

 Patients younger 18

 Preexisting renal insufficiency

['Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery']


Lifestyle Intervention for Heart Failure

Summary: The goal of this behavioral research study is to learn if education and training about exercise can help to change the lifestyle of cancer survivors with symptoms of heart failure.
Inclusion criteria: inclusion criteria:

 diagnosis of NYHA I, II or III heart failure (as identified by any of the following physical findings of heart failure (jugular venous distension, crackles, edema, S3); pulmonary edema on chest x-ray; BNP > 100 pg/ml; or at least two of the following symptoms: paroxysmal nocturnal dyspnea, shortness of breath, swelling, fatigue;

 previous chemotherapy that contributed to the development of heart failure (i.e., heart failure develops or worsens after receiving chemotherapy, with no other obvious explanation);

 oriented to person, place, and time;

 living in the Houston area (Harris county or a contiguous county), or planning to stay in the area for at least the next 16 weeks.

 18 years of age or older.

 diagnosis of cancer

 have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only

Exclusion criteria: :

 remain in NYHA class IV heart failure despite therapy;

 have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist;

 cannot provide informed consent;

['Usual Care', 'Exercise Training', 'Dietary Counseling']

Usual Care
Exercise Training
Dietary Counseling


Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

Summary: The purpose of this randomized clinical trial is to examine the usefulness of the addition of a pelvic compression belt to a lumbopelvic stabilization program for patients with sacroiliac joint pain by comparing lumbopelvic stabilization exercises with a pelvic compression belt to lumbopelvic stabilization exercises alone. Outcome measures including the Modified Oswestry Low Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness (i.e. muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric Pain Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement using the Global Rating of Change (GROC) scale will be collected. Hypothesis: The OSW scores and NPRS scores will be lower for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone. The percent change of muscle thickness for the deep abdominals as well as the GROC scores will be higher for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone.
Inclusion criteria: inclusion criteria:

 unilateral pain near the sacroiliac joint that does not extend pass the knee

 positive result on 2 of 6 sacroiliac joint provocation tests:

 compression test

 distraction test

 posterior shear test

 Gaenslens' test (left and right)

 sacral thrust test

Exclusion criteria: :

 current pregnancy or pregnancy in the last 6 months

 history of surgery to lumbar spine, pelvis, chest, abdomen

 history of congenital lumbar or pelvic anomalies

 any neurological signs in the lower extremity

['Lumbopelvic stabilization exercise', 'Sacroiliac joint belt']

Lumbopelvic stabilization exercise
Sacroiliac joint belt


Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease

Summary: Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths attributed to cardiovascular events. Cardiovascular diseases will become an increasing problem as the Iranian population ages.~In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a single preparation. They proposed that this treatment should be offered to all persons at high risk of cardiovascular disease whether or not they have elevated blood pressure or elevated serum lipid concentrations.~This pilot study aims to investigate the safety and efficacy of fixed-dose combination therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would not currently be considered eligible for antihypertensive treatment or for lipid lowering treatment.~Methods:~This is a double-blind randomized controlled trial. The intervention group will be assigned to take a tablet consisting of a single daily tablet comprising Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be assigned to an identical placebo.~The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80 (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore lipid lowering therapy are excluded.~It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for the purpose of sample size calculation is change in systolic blood pressure. Additional outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence of adverse events.
Inclusion criteria: inclusion criteria

 All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year.

Exclusion criteria:

 Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)

 Already taking antihypertensive drugs, aspirin or statins

 Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.

 Blood pressure >160/100 mm Hg

 Total Cholesterol > 240 mg/dL (or LDL >190 mg/dL)

 Probable diabetes: HbA1c >6.0

 Contraindication to a component of the Polypill

 Contraindications to aspirin

 Previous history of allergy to aspirin

 History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months

 Contraindications to statins

 Liver failure Contraindications to further blood pressure lowering

 Systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤70 mm Hg

 Symptomatic postural hypotension

 Difference between mean seated BP and standing BP greater than 20 mm Hg

 Contraindications to thiazide

 Uric acid >8 for men and uric acid >6 for women / gout (

 10%)

 Creatinine >1.2 mg/dl

 Other predominant medical problem that may limit compliance with study treatment including:

 History of alcohol abuse: more than 60cc for women and more than 80cc for men

 History of drug abuse: IV drug abuser or eating or smoking more than 4 times a week

 Limiting psychiatric illness (eg: mania, schizophrenia, severe depression, psychosis or dementia)

 Limiting physical disability sufficient to prevent subject from walking

 Other life-threatening condition such as cancer

['Cardiovascular Disease', 'Hypertension', 'Hyperlipidemia', 'Heart Disease']

Cardiovascular Disease
Hypertension
Hyperlipidemia
Heart Disease


Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions

Summary: The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.
Inclusion criteria: inclusion criteria:

 female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months.

Exclusion criteria: :

 has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives

 has other concurrent/active STD's

 has a history of known prior vaccination with an HPV vaccine

 has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.


Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW

Summary: There is a need for better visualization of polyps during surveillance endoscopy in patients with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the determination of the optimal tracer dose.
Inclusion criteria: inclusion criteria:

 Patients with genetically or clinically proven Familial Adenomatous Polyposis. Genetically proven: Adenomatous Polyposis Coli (APC)-mutation identified. Clinically proven: more than 100 colorectal polyps at diagnosis

 Age 18 to 70 years

 Written informed consent

 Adequate potential for follow-up

Exclusion criteria: :

 Medical or psychiatric conditions that compromise the patient's ability to give informed consent

 Proctocolectomy

 MutYH mutation

 Concurrent uncontrolled medical conditions

 Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre-menopausal women with intact reproductive organs and women less than two years after menopause.

['Bevacizumab-IRDye800CW', 'Near infrared fluorescence endoscopy platform']


Conventional Infertility Treatment vs. Fast Track to IVF

Summary: The purpose of this randomized prospective clinical trial is to determine whether an infertility treatment that moves quickly to In Vitro Fertilization (IVF) is more cost effective than the usual treatment strategy which includes various combinations of infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro Fertilization.
Inclusion criteria: inclusion criteria:

 Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse.

 Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict criteria, or >5 million total motile sperm on IUI prep.

 Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube.

 Patients with surgically corrected stages I and II endometriosis will be included.

 Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study).

 Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for inclusion, prior to any gonadotropin therapy.

 Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin.

 Female body mass index ≤ 38.

Exclusion criteria: :

 Previous tubal reconstructive surgery in which the pelvis was not restored to functional.

 Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes.

 A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis.

 One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent.

 Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict criteria, or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded.

 Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins.

 Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL.

 Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET).

 Female body mass index > 38.


Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

Summary: Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as well. Hyperpigmented plaques will be changed. We assess objective measurement by using spectroscopic and colorimetric analysis.
Inclusion criteria: inclusion criteria:

 Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state.

 Subjects must carry a diagnosis of acanthosis nigricans, which will be verified by a Dermatologist before entry into the study. If necessary, a small 4mm punch biopsy may be taken to document dermatopathology consistent with acanthosis nigricans.

 Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up.

 Agree to abide by the investigator's guidelines

 Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form

 Agree to follow and undergo all study-related procedures

Exclusion criteria: :

 Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states.

 Women who are lactating, pregnant, or planning to become pregnant.

 Any reason the investigator feels the patient should not participate in the study.

 -

['Acanthosis Nigricans', 'Hyperinsulinemia', 'Spectroscopic Analysis']

Acanthosis Nigricans
Hyperinsulinemia
Spectroscopic Analysis


Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.

Summary: The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
Inclusion criteria: inclusion criteria:

 Subject is ≥18 years of age and has type 1 or 2 diabetes

 Texas grade 1a or 2a wound located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth ≤ 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts

 Prior to inclusion of an ulcer in the study, each wound will be reviewed for eligibility by an independent assessor using a central online review process that includes images of the ulcer.

 For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosen as the study ulcer.

 Ulcer size between 1 cm2 and 12 cm2 (post-debridement).

 Ulcer duration of ≥ 30 days. Time 0 for ulcer duration of ≥ 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all inclusion criteria, including lack of ulcer healing until day 0.

 Study ulcer separated from other ulcers by at least 2 cm.

 Ulcer or affected limb free of clinical signs of infection. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection).

 Post-debridement, ulcer free of necrotic tissue.

 Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following: (a) Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2; (b) toe pressure (plethysmography) > 50 mm Hg; (c) TcPO2 > 40 mm Hg; or (d) skin perfusion pressure (SPP) > 30 mm Hg.

 HbA1c ≤ 12.0% (diabetic patients)

 Demonstrated adequate offloading regimen.

 Subject must be willing to comply with the protocol including having blood drawn to create the RD1.

 Female subjects who are capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women).

Exclusion criteria: :

 Ulcer not of neuropathic diabetic foot pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, or arterial etiology, or pressure ulcers.).

 Presence of underlying osteomyelitis.

 Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection.

 History of alcohol or substance abuse, within the previous 2 months

 Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of randomization visit.

 Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).

 Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization or is scheduled to receive during the study.

 Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study.

 Wound on a patient who has a life expectancy of less than 12 months.

 Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form.

 Cannot withdraw blood in the required amount (up to 10 mL per week) technically.

 Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Patients who are taking coumadin, aspirin, or Plavix (clopidogrel) will not be excluded.

 Hemoglobin anemia (< 10 g/dL).

 Subject has a history of or any of the following intercurrent illnesses or conditions that would compromise the safety of the subject, or the normal wound healing process:

 End stage renal disease

 Immunosuppression.

 Severe malnutrition

 Liver disease

 Scleroderma

 Acquired immune deficiency disease (AIDS) or HIV positive

 Connective tissue disorder

 Exacerbation of sickle cell anemia

 If ulcer area decreases by ≥ 30% during the initial 2-week screening (± 2 days) and standard of care phase, or if the ulcer area increases ≥ 30%, subject will be excluded.

 Women who are pregnant or currently breast feeding.


Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting

Summary: To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
Inclusion criteria: inclusion criteria:

 CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.

 Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD)

 Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease.

Exclusion criteria: :

 Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease;

 Subjects with acute decompensated heart failure currently on nesiritide therapy;

 Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and

 Subjects unable to or refusing to provide written informed consent.


Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia

Summary: Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia.~Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia.
Inclusion criteria: inclusion criteria:

 Children aged 6 months to 12 years attending sickle cell clinic in Mulago Hospital during the study period with a negative peripheral smear for parasites, adherence to appointment visits, consent by care takers to participate in the study.

Exclusion criteria: :

 Patients with known allergy to sulfonamides, Patients with severe illnesses requiring urgent admission, Patients with documented treatment for malaria in the past one month with Sulfadoxine- Pyrimethamine. Patients on cotrimoxazole prophylaxis


Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease

Summary: Patients with Parkinson's disease represent a significant proportion of VA elderly patients. Sleep disturbances and caregiver burnout association with this condition represent a significant problem. In this study, the investigators propose to perform an evaluation of a fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease.~The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinson's disease while indirectly improving the quality of life for the patients and caregivers. The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture.
Inclusion criteria: inclusion criteria:

 45-85 years of age and living in the community

 Male or female of non-child bearing potentials (non-child bearing is defined as at lease 6 months post-menopause or surgically sterile)

 Must have a diagnosis of Parkinson's disease

 Must have complaints of sleep disturbance

Exclusion criteria: :

 Patients with diagnosis of or those meeting DSM-IV criteria for major depression, schizophrenia or schizoaffective disorder, bipolar disorder, substance abuse disorder, other mental illness that is known to contribute to sleep disturbance, epilepsy, other medical conditions that are known to cause or contribute to sleep disturbances

 Patients currently using melatonin or ramelteon, hypnotics, benzodiazepines, antidepressants, blood-brain barrier permeable beta blockers, steroids, antipsychotics

 Patients with clinically significant blood or urine abnormalities

 Patients who have taken any investigational drug less than 1 month prior to the baseline visit

 Patients with multiple concomitant disorders with or without medications thought to produce sleep disturbances

 Patients with pre-existing sleep disturbances unrelated to Parkinson's disease

 Patients with severe hepatic impairment (Child-Pugh Class C)

 Patients with severe COPD (those with elevated pCO2 levels or those needing nocturnal oxygen therapy

 Patients with severe sleep apnea

 Patients who have sensitivity to ramelteon or any constituents of the Rozerem preparation

 Patients taking rifampin or potent inducers of CYP1A2, CYP3A4, CYP2C9 (ketoconazole, fluconazole)

 Patients living in a nursing home. Those living in assisted living facilities and board and care facilities may be included

 Patients unable to comply with the study protocol


Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease

Summary: This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.
Inclusion criteria: inclusion criteria:

 Male or Female over 18 years of age

 Moderate or Complex Congenital Heart Disease

 Willingness to Consent

Exclusion criteria: :

 Pregnancy

 Surgery within 6 months

 Unrepaired cyanotic heart disease

 Patients with Eisenmenger Syndrome physiology


Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

Summary: The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.
Inclusion criteria: inclusion criteria:

 The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features.

 corneal epithelial defect with stromal infiltration

 reaction in anterior chamber

 positive for bacteria or fungus

 The patients have to receive subconjunctival antibiotic injection twice at least.

 The patients must be informed consent.

Exclusion criteria: :

 The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs.

 The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection.

 Unable to cooperate with the treatment.

 Pregnant women


Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion

Summary: Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects.~The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear.~The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin
Inclusion criteria: inclusion criteria:

 upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg

 endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum

 they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks

 18 years old or older.

Exclusion criteria: :

 concurrent erosive or ulcerative esophagitis

 pyloric stenosis

 previous gastric or duodenal surgery other than oversewing of a perforation

 thrombocytopenia

 renal failure with estimated creatinine clearance less than 10 ml / min

 active cancer

 known allergic to aspirin, famotidine or pantoprazole

 pregnancy, lactation, child-bearing potential in the absence of contraception

 psychosomatic disorder

 planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant

 disorders that might modify the absorption of study drugs


Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients

Summary: The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
Inclusion criteria: inclusion criteria:

 Allogeneic stem cell transplant recipient

 Recipient or donor CMV seropositive

 Have transplant engraftment

 Able to swallow tablets

Exclusion criteria: :

 CMV organ disease

 HIV infection

 Use of other anti-CMV therapy post-transplant


Study on Early Lyme Neuroborreliosis

Summary: The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.
Inclusion criteria: inclusion criteria:

 erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old

Exclusion criteria: :

 pregnancy

 lactation

 history of adverse reaction to a beta-lactam antibiotic


Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars

Summary: This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with a argon gas based device in treating keloids and hypertrophic scars in population consisting of all Fitzpatrick skin type patients
Inclusion criteria: inclusion criteria:

 Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion

 Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)

 A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks

 Patients with all Fitzpatrick17 skin types

 Patients older than 10 years of age

Exclusion criteria: :

 pregnancy

 diabetes mellitus


A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)

Summary: To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with salbutamol alone given every 20 minutes for three doses in asthmatic children with severe acute exacerbation
Inclusion criteria: inclusion criteria

 All patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation.

 Male or female patients 2 to 10 years of age.

 Parents or legal guardians of patients must sign an Informed Consent Form prior to participation in the trial.

Exclusion criteria:

 Patients with known or suspected hypersensitivity to study drugs

 Patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications

 Patients with first wheezing episode only

 Prior intubation for asthma for more than 24 hours

 Patients who used ipratropium within six hours prior to consultation

 Patients with concurrent stridor or possible presence of intra-thoracic foreign body

 Patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease)

 Patients requiring immediate resuscitation or airway intervention

 With psychiatric disease or psychosocial problems

 Patients on other investigational drugs or have used any other investigational drugs within the past month

['ipratropium plus salbutamol UDV', 'salbutamol UDV']

ipratropium plus salbutamol UDV
salbutamol UDV


Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia

Summary: The purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).
Inclusion criteria: inclusion criteria:

 30-80years old

 Caregivers who spend their own time with dementia patients over 4 hours a day

 caregiver distress scores >= 2

 caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10

 26)

Exclusion criteria: :

 illiterate

 severe hearing/visual acuity difficulty

 cognitive impairment


Study of Tocilizumab to Treat Polymyalgia Rheumatica

Summary: This is a fifteen-month open label, Phase IIa clinical trial is being conducted to assess the tolerability, safety and efficacy of a medication called Tocilizumab (Actemra®) in patients with polymyalgia rheumatica (PMR).
Inclusion criteria: Disease- Specific inclusion criteria:

 Patients must meet the following inclusion criteria to be eligible for study entry:

 Diagnosed with polymyalgia rheumatica and enrolled within one month of diagnosis.

 Disease Specific
Exclusion criteria: :

 Patients will be excluded from the study based on the following criteria:

 Symptoms or diagnosis of temporal arteritis, including headache, jaw claudication, hyperesthesia of scalp, abnormal palpated temporal artery, visual disturbances, temporal artery biopsy positivity

 Concurrent rheumatoid arthritis

 Presence of rheumatoid factor and CCP

 Other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, polymyositis, dermatomyositis, mixed connective tissue disease

 Treatment of polymyalgia rheumatica with more than 20mg of daily prednisone or its equivalent at the time of screening

 Treatment with more than 30mg of daily prednisone or its equivalent since diagnosis. Treatment with 30mg of daily prednisone or its equivalent since diagnosis for more than 2 weeks.

 More than 4 weeks of corticosteroid therapy prior to enrollment

 History of bowel perforation within the past five years.

 Active diverticulitis.

 Pre-existing or recent onset demyelinating disorders


Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm

Summary: This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.
Inclusion criteria: inclusion criteria:

 Veterans over 21 years of age

 with chronic lower extremity or diabetic foot ulcers (wound duration over 8 weeks)

 who at the clinician's judgment requires wound debridement (25% or more of wound bed covered with non-viable tissue)

 wound size 1.5 cm (roughly the size of a quarter) or larger in diameter

Exclusion criteria: :

 Cognitive impairment that would interfere with patient signing own Informed Consent

 Veterans on active anticoagulant therapy with most recent (within last week) PT/INR (international normalized ratio of prothrombin time) > 3.0, or other significant bleeding risk

 Active immune suppression just prior to or during study (on systemic corticosteroids* within 7 days prior, or chemotherapy for cancer or RA treatment within 4 weeks prior to study, or with diagnosis of HIV/AIDS) - *Nasal steroid sprays will not be excluded

 Active systemic antibiotics is an exclusion

 Absent dorsalis pedis pulses and Ankle Brachial Index (ABI) < 0.5 is an exclusion (indicates critical limb ischemia).

 Other possible reasons participants could be removed from this study include: transfers to other non-VA facilities, participant is unable to tolerate tissue sampling even with local anesthesia, and/or inability to comply with scheduled research visits. Furthermore, if the participant has significant wound healing so that sampling is not possible after the initial sampling, they will be removed from the study.

['Larval Debridement Therapy', 'Bedside Sharp Debridement']

Larval Debridement Therapy
Bedside Sharp Debridement

['Lower Extremity or Diabetic Foot Ulcers', 'Bacterial Infection']

Lower Extremity or Diabetic Foot Ulcers
Bacterial Infection


Home-delivered Intervention for Depressed, Cognitively Impaired Elders

Summary: Among older adults the combination of depression, cognitive impairment (memory problems), and disability contribute to a worsening of physical and mental health and to poor treatment outcomes. Antidepressants help fewer than 40% of depressed elders with memory problems achieve remission from their depression. Interventions involving talking therapy are underdeveloped and understudied. Therefore, this research study will test the efficacy of Problem Adaptation Therapy (PATH), a new home-delivered psychosocial intervention for elders with major depression, memory problems, and disability. PATH focuses on the subject's ecosystem (the patient, the caregiver, and the home-environment) and targets behavioral problems related to both depression and disability.~PATH is delivered in a subject's home, where cognitively impaired, disabled elders face most of their difficulties. Local Home Delivered Meals programs will refer clients who have symptoms of depression and are interested in research. All participants will have an available caregiver (family, significant other, or professional) and will be randomized to 12 weekly sessions of PATH or Supportive Therapy, the current standard of care for talking therapy. The study will test whether home-delivered PATH is more effective than home-delivered Supportive Therapy in reducing the subjects' depression and disability and in increasing self-efficacy over the 12-week treatment period.
Inclusion criteria: inclusion criteria

 Age: >64 (65 years and older).

 Diagnosis: Major depression, unipolar as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID), using Diagnostic and Statistical Manual for Mental Disorders (DSM)IV criteria.

 Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18.

 Disability, i.e. impairment in at least 1 Instrumental Activity of Daily Living as measured by Philadelphia Multilevel Assessment Instrument - Instrumental Activities of Daily Living subscale (MAI-IADL).

 Evidence of at least mild cognitive impairment but not severe impairment (Dementia Rating Scale (DRS) total score between 90 and 133 inclusive).

 Caregiver (family member or professional) able and willing to participate in treatment.

 Off antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 12 weeks and no medical recommendation for change of these agents in the near future.

 Command of English sufficient to participate in therapy and research assessments.

Exclusion criteria:

 High suicide risk, i.e. intent or plan to attempt suicide in near future.

 Axis I psychiatric disorder or substance abuse other than unipolar major depression, non-psychotic depression.

 Axis II diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria).

 Moderate to Severe Dementia: We will exclude participants with DRS Total Score corresponding to moderate or more severe dementia (DRS Total <=90).

 Acute or severe medical illness (i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry); drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids); or chronic addictive drug use.

 Current involvement in psychotherapy.

 Aphasia.

['Problem Adaptation Therapy (PATH)', 'Supportive Therapy']

Problem Adaptation Therapy (PATH)
Supportive Therapy


Post Partum Thyroiditis 2: Long Term Observations

Summary: The study tries to determine if post partum thyroiditis has marked long term (20 years after partum) risk for developing hypothyroidism.
Inclusion criteria: inclusion criteria:

 Defined group of women who tested positive for post partum thyroiditis in 1985.

 Control group randomly picked from those who tested negative.

Exclusion criteria: :

 -


Heart Failure, Functional and Cognitive Decline, and Psychiatric Symptoms in Nursing Home Patients

Summary: Heart failure is very common in the elderly, in whom it may lead to functional and intellectual problems. Functional problems include loss in the ability to perform basic tasks of daily living such as bathing or dressing. No studies have yet described the rate at which heart failure causes these problems to develop. This study aims to find out whether nursing home patients deteriorate more quickly with respect to function and intellect if they have heart failure. Participants will undergo a thorough health history and physical examination and will be followed every 3 months for up to a year. Over 30 nursing homes in Kitchener, Waterloo, Cambridge, and Hamilton, in South Central Ontario (Canada), are participating in this study. Every 3 months, participants will be reviewed with respect to function, intellect, mood and behaviours. Results between those with heart failure will be compared to those of people without heart failure. The results of this study will be used to plan further studies to see whether good treatment of heart failure can preserve function, intellect, and prevent depression and other mood problems.
Inclusion criteria: inclusion criteria:

 All new residents to participating long-term care facilities

 Age 65 or over

Exclusion criteria: :

 Residing in any long-term care facility for more than 8 weeks

 Inability or refusal to obtain informed consent

 Palliative diagnosis and not expected to survive 6 weeks

 Residents admitted for respite care and expected to be returned to the community


Splenic Function After Spleen-Preserving Distal Pancreatectomy With Excision of Splenic Artery and Vein

Summary: The spleen may be removed due to benign hematologic disorders, such as idiopathic thrombocytopenic purpura and hereditary spherocytosis, or malignancies, such as lymphomas and leukemias. Splenectomy may also be performed due to splenic traumas or in association of some surgical procedures, when combined splenectomy will make the operations easier. The most well known procedure is distal pancreatectomy combined with splenectomy.~In this research, there are two main goals. Firstly, establish the data about the incidence of overwhelming postsplenectomy infection (OPSI) in our country. Currently, the western data of the incidence, morbidity rate and mortality rate of OPSI is well established and vaccination along with prophylactic antibiotics is strongly recommended. Since the incidence of OPSI in our country isn't clear, most (>95%) splenectomized patients in our hospital (National Taiwan University Hospital) did not have vaccination or prophylactic antibiotics. We'll try to determine the incidence of OPSI by reviewing of our hospital charts and by structured interviews with patients.~The spleen is a phagocytic filter. So asplenic patients have higher risks of getting infection and some spleen-preserving procedures are proposed. In our initial experiences, distal pancreatectomy with splenic artery and vein divided could be safely performed and greatly increased the possibility of preservation of spleen. However, when the spleen was preserved with dividing the splenic artery and vein, the blood supply to the spleen will be shifted from splenic artery to short gastric artery. Although a substantial immunologic advantage exists if splenic tissue remains, this may not offer sufficient protection from encapsulated bacteria if splenic arterial blood flow is reduced because experimental animal studies have demonstrated that an intact splenic arterial system is necessary for optimal control of infection. Thus, although the spleen is preserved in above mentioned procedure, the function of the preserved spleen is questionable and has never been studied of. Our second object is to determine the splenic function after after spleen-preserving distal pancreatectomy with excision of splenic artery and vein by comparison of abdominal computed tomography and immunological function of patients before and after operation. Besides, we'll designed an animal experiment to examine the rate of pneumococcal clearance by the spleen and to determine the relationship between splenic blood flow and splenic tissue mass in bacterial clearance from the blood when the splenic vessels were divided.
Inclusion criteria: inclusion criteria:

 all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years.

Exclusion criteria: :

 who rejected interview.


Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

Summary: The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
Inclusion criteria: inclusion criteria:

 Onset of seizures in the first year of life

 History of fever-induced prolonged seizures as determined by the Investigator

 These may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures

 Multiple seizure types which may include:

 generalised tonic-clonic (required for inclusion)

 clonic (required for inclusion)

 myoclonic jerks/seizures

 history of normal development prior to seizure onset followed by development delay or regression after seizure onset

 abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks

Exclusion criteria: :

 The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives

 The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives

 The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids

 The patient has received chronic treatment (≥2 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed

 The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy

 Other protocol-defined inclusion and


Multimodal DVT Protocol in Tourniquet-less Total Knee Arthroplasty

Summary: The Cothera VPulse(tm) mechanical compression device (MCD) combines rapid intermittent sequential compression with cold therapy and is designed for single patient use in the home. Additionally, it can track patient compliance. This study will examine if there is a difference in deep vein thrombosis (DVT) occurrence over 3 weeks after tourniquet-less total knee arthroplasty (TKA) and multimodal prophylaxis with or without extended MCD use in a cooling device/MCD system.
Inclusion criteria: inclusion criteria:

 TKA candidacy, osteoarthritis, patients able to understand study intent, and agree to study participation

Exclusion criteria: :

 Subjects with personal or family history of DVT, currently taking antiplatelet/anticoagulant drugs, genetic risk factor positive for VTE, pronounced thrombocytopenia, GI bleed within 6 months of surgery, NSAID intolerance, orthopaedic and medical co-morbidities that would prevent postoperative rapid mobilization and compliance with MCD such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity, post-traumatic and inflammatory arthritis, BMI above 40, active knee sepsis, remote sites of active infection, ASA class > lll, cardiac disease failing medical clearance, severe liver disease, peripheral artery disease, seizure disorder, alcohol abuse, smoking abuse


RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants

Summary: The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission
Inclusion criteria: inclusion criteria:

 Born in San Francis Designated District Hospital of Ifakara

Exclusion criteria: :

 Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus

 Twins

 Birth weight < 1,5 kg

 Clinical signs of cerebral asphyxia

 Clinical signs of neonatal or congenital infection

 Mother unreliable (deaf, mentally handicapped)

['Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)', 'iron (2 mg/kg/daily)']