Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis

Summary: The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
Inclusion criteria: inclusion criteria:

 Subject is at least 18 years of age

 Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis

 Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities:

 Have a clinically typical appearance

 Be treatment naïve

 Have a Physician Lesion Assessment (PLA) of ≥2

 Have a longest axis that is ≥7mm and ≤15mm

 Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm

 Have a thickness that is ≤2mm

 Be a discrete lesion

 Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present

 Not be in an intertriginous fold

 Not be in an area where clothing, such as a bra, might cause physical irritation

 Not be pedunculated.

 If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active form of birth control for the duration of the study

 Subject is non-pregnant and non-lactating

 Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation

 Subject is willing and able to follow all study instructions and to attend all study visits

 Subject is able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion criteria: :

 Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions

 Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)

 Subject has a current systemic malignancy

 Subject has a history of keloid formation or hypertrophic scarring

 Subject has used any of the following systemic therapies within the specified period prior to Visit 1:

 Retinoids; 180 days

 Glucocorticosteroids; 28 days

 Anti-metabolites (e.g., methotrexate); 28 days

 Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, that in the investigator's opinion, interferes with the application of the study medication or the study assessments:

 LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy; 180 days

 Retinoids; 90 days

 Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days

 Glucocorticosteroids or antibiotics; 14 days

 Moisturizers/emollients, sunscreens; 12 hours

 Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to the target lesion that, in the investigator's opinion, interferes with the application of the study medication or the study assessments:

 A cutaneous malignancy; 180 days

 Experienced a sunburn; 28 days

 A pre-malignancy (e.g., actinic keratosis); currently

 Body art (e.g., tattoos, piercing, etc.); currently

 Excessive tan; currently

 Subject has a history of sensitivity to any of the ingredients in the study medications

 Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations

 Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

['A-101 Vehicle', 'A-101 (40) Topical Solution', 'A-101 (32.5) Topical Solution']

A-101 Vehicle
A-101 (40) Topical Solution
A-101 (32.5) Topical Solution


An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)

Summary: The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.
Inclusion criteria: inclusion criteria:

 Non-smoker

 A 2-year documented history of seasonal allergic rhinitis

 A 1-year documented history of chronic asthma

 Positive allergy testing

Exclusion criteria: :

 Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

['MK0476, montelukast sodium', 'Comparator: placebo']

MK0476
montelukast sodium
Comparator: placebo

['Rhinitis, Allergic, Seasonal', 'Asthma, Bronchial']

Rhinitis Allergic Seasonal Asthma Bronchial


Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica

Summary: Rheumatic Polymyalgia(PMR) is a relatively common chronic inflammatory disorder of unknown origin which predominantly develops in elderly subjects and presents with severe pain and stiffness in the neck, shoulder and pelvic girdles, along with increased acute phase reactants. Systemic manifestations such as fever, anorexia and weight loss are characteristic signatures of PMR.~Corticosteroids (CS) constitute the standard treatment of PMR. Although in most patients the symptoms of the disease disappear after one or two years of treatment, a proportion of patients remain CS-dependent with the subsequent CS toxicity. Open label studies have suggested that tumour necrosis factor (TNF) antagonists lead to sustained improvement and CS sparing effect in patients with refractory PMR.~The investigators conducted a randomised, double-blind, placebo controlled trial with infliximab in CS-dependent patients with PMR. Patients with CS-dependent PMR (defined as requiring ≥ 5 mg/day after at least 2 years of treatment to maintain remission or ≥ 7.5 mg/day after at least 6 months) were randomly assigned to receive Infliximab (5 mg/kg i.v) at 0, 2, 6, 14 and 22 weeks (n = 12) or placebo (n = 11) together with CS that were reduced according to a predefined schedule. The primary outcome was the proportion of responder patients -defined as individuals with both complete clinical and analytical remission without receiving CS for at least three months- at 24 weeks. Secondary outcomes were cumulative CS doses and adverse events proportion.
Inclusion criteria: inclusion criteria:

 PMR patients that after 2 years of corticosteroid treatment are not able to reduce the dose of prednisone below 5 mg/day or equivalent.

 PMR patients that after 6 months of corticosteroid treatment are not able to reduce the dose of prednisone below 7,5 mg/day or equivalent.

 PMR patients should fulfill the criteria proposed by Chuang et al (8):

 Age ≥ of 50 years.

 Development of bilateral moderately/severe aching and stiffness persisting for 1 month or more, involving two of the following areas: neck or torso, shoulders or proximal regions of the arms, and hips or proximal aspects of the thighs.

 ESR ≥ 40 mm/h.

 Complete clinical response to low-dose of steroids (prednisone or equivalent ≤ 20mg/day)

Exclusion criteria: :

 -Patients with biopsy-proven GCA or those with cranial symptoms or signs suggestive of GCA but without biopsy-proven arteritis.

 Patients with clinical features suggestive of RA or other connective tissue disorders.

 Chronic infections such as HIV, hepatitis B or C, active mycobacterial or fungal infections, etc.

 Neoplasm or a history of malignancy in the preceding 5 years.

 Patients with multiple sclerosis or other demilinizating disorders.

 Patients with cytopenias: leukopenia (leukocytes ≤ 3.5x109/L.), thrombocytopenia (platelets ≤ 100x109/L.) and/or anemia (≤ 10 g./dl.)

 Patients with cardiac failure (functional class III / IV).

 Any other condition that contraindicates Infliximab therapy


Feasibility of Peripheral Angioplasty in Type D TASCII Lesions

Summary: This observational prospective study will evaluate, according o usual local clinical practice, feasibility of endoluminal revascularization in diabetic patients with type C and D lesions, according to TASC II Criteria.~About 300 patients will be treated with usual revascularization procedure. Each patient will be followed at least 12 months to evaluate clinical outcome and limb salvage interventions.
Inclusion criteria: inclusion criteria:

 Adult diabetic patients type 1 or 2

 Chronic critical ischemia as defined by TASC 2007 criteria (pain at rest, and/or ulcer or gangrene due to arteriopathy: transcutaneous oximetry < 30 mmHg or pressure on the ankle < 70 mmHg)

Exclusion criteria: :

 Cancer with adverse prognosis in months, or chemotherapeutic treatment

 Ongoing or planned pregnancy

 Lack of consent to participate to the study


Child Care Wellness Study on Nutrition and Physical Activity

Summary: The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.
Inclusion criteria: inclusion criteria:

 In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy.

Exclusion criteria: :

 If the randomly selected child care center has an open case of child abuse or neglect.

['NAP-SACC Child Care Wellness Program']


Community Acquired Pneumonia in Telemark and Ostfold

Summary: The aim of the study is to investigate the bacterial causes in community acquired pneumonia in adults admitted to hospital in two counties in Norway and to look at possible factors that makes the patients susceptible to pneumonia.
Inclusion criteria: inclusion criteria:

 Symptoms of lower airway infection and radiologic sings of pneumonia.

Exclusion criteria: :

 Age<18

 Serious psychiatric illness

 Mentally retarded

 Hospitalized last 14 days


Magnesium and Asthma - Clinical Trials

Summary: Asthma currently affects an estimated 15 million Americans. A number of studies have found an association between low dietary magnesium (Mg) intake and increased asthma incidence and severity of symptoms. However, clinical intervention trials are necessary to directly assess whether there is a true protective or preventative causal relationship between low Mg and asthma. In our study, we will assess the effects of 6 1/2 months of oral Mg supplements or placebo on clinical markers of asthma control, indirect biomarkers of inflammation, bronchial hyperresponsiveness, and indices of oxidative defense and damage in subjects with mild to moderate persistent asthma.
Inclusion criteria: Mild to moderate persistent asthma (NAEPP 1997 revised guidelines)

 Current use of inhaled beta-2- agonists or steroid inhaler therapy only (No use of prednisone in past 3 months)

 No use of products (i.e. antacids, laxatives, supplements) containing more than 50 mg Mg daily in the last 3 months

 No current use of theophylline, leukotriene antagonists, or other systemic immunomodulating compounds

 Nonsmoker

 No concurrent pulmonary disease (pulmonary hypertension, cystic fibrosis, sarcoidosis, bronchiectasis, hypersensitivity pneumonitis, restrictive lung disease, abnormal DLCOva)

 No concurrent medical diagnoses (alcoholism, coronary artery disease, diabetes, HIV infection, chronic hepatitis, uncontrolled hypertension, chronic renal failure or a psychiatric disorder that is judged to make full participation difficult)

 Not pregnant or lactating.
Exclusion criteria:


Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation

Summary: Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance.~Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.
Inclusion criteria: inclusion criteria:

 Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure)

 Patient must have signed the consent form

 Male or female patient aged 18 or over

 One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the MAGERL classification, and with a regional kyphotic angle > 15° and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression

 Fracture with or without neurological difficulties

 Non tumoral origin: Confirmed by biopsy at the same time of the Balloon Kyphoplasty procedure.

Exclusion criteria: :

 Non- traumatic, malignant or osteoporotic vertebral fractures

 History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.

 Known allergy to a contrast media or to one of the cement components used for kyphoplasty.

 More than two recent vertebral fractures

 Current infection

 Impossibility to perform the percutaneous approach of the vertebra to treat.

 Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat.

 Vertebral fracture with loss of 90%or more of the vertebral body height

 Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.

 Evolutive cardiac disease nonreactive to medical treatment

 Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year.

 Pregnant or breast feeding women

 Patient not affiliated to social security

['One or Two Traumatic Vertebral Fractures', 'Located Between T11 and L5', 'Balloon Kyphoplasty']


Human Immune Responses to Yellow Fever Vaccination

Summary: The goal of this study is to use the live attenuated yellow fever vaccine, YFV-17D (YF-VAX®, Sanofi-Pasteur) as a safe and effective model for viral infection to understand human immune response to viral antigens. Study participants will receive the yellow fever vaccine and participation in the study may be as short as one month or as long as one year, depending on immune responses.
Inclusion criteria: inclusion criteria:

 Able to understand and give informed consent

 Age 18-45 years

 If possible, participants agree not to take any vaccines within 30 days before or 30 days after yellow fever vaccination

 Women of child bearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to vaccination.

Exclusion criteria: :

 Lived in a country/area which is endemic for yellow fever

 History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, Japanese encephalitis vaccination or infection

 Any history of allergy to eggs, chicken or gelatin or to any previous vaccine

 A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.

 History of HIV infection, Hepatitis B or Hepatitis C infection

 History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal diseases and uncontrolled hypertension). Use of systemic immunosuppressive medications (ex, prednisone) for 2 weeks or more in the past 3 months

 History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial

 Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of autoimmune disorder

 Recipient of a blood products or immune globulin product within 42 days of the vaccination visit

 Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration

 Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial

 Received the second coronavirus disease 2019 (COVID-19) vaccine less than 21 days before receiving the Yellow Fever Vaccine.

 COVID-19 infection in the last 60 days. Symptoms of COVID-19 symptoms must be completely resolved before yellow fever vaccine receipt.


Effects of Images Following Long-term Aerobic Exercise on Brain Activation

Summary: The primary purpose of this study is to quantify activation of regions of the brain associated with appetite and reward after viewing high sugar and high fat (HS/HF) images compared to control images following long-term aerobic exercise.~After long-term aerobic exercise compared to a no-exercise control group, viewing HS/HF food images vs. control images will result in higher activation of regions of the brain associate with appetite (hypothalamus).~After long-term aerobic exercise compared to a no-exercise control group consumption of a sucrose solution compared to an artificially sweetened solution and a tasteless solution, viewing HS/HF food images vs. control images will result in lower activation of regions of the brain associated with reward [amygdala, anterior cingulate cortex (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA), striatum, insula] in overweight and obese men and women.~Exploratory Aims As exploratory aims, investigators will test a preliminary brain connectivity analysis.
Inclusion criteria: inclusion criteria:

 Male or Female

 18-65 years old (inclusive)

 Weigh less than 350 lbs

 Body mass index (BMI) between 25-43 kg/m2

 Willing to fast for 10 hours prior to examination

 Right handed

Exclusion criteria: :

 Diagnosis (by self report) of diabetes

 Diagnosis (by self report) of neurological condition

 Current or past alcohol or drug abuse problem

 Smoking

 Have internal metal medical devices including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws/clips, metal plates, metal fragments in your eye, or non-removable metal jewelry such as rings

 Unable or unwilling to complete the imaging procedures for the duration of the MRI scan due to claustrophobia or other reason


Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients

Summary: Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.
Inclusion criteria: inclusion criteria:

 patient is admitted to the ER with shortness of breath

 patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including:

 asthma management protocol

 bronchiolitis management protocol

 ages 0 - 15

 patient's parent/guardian is able to comprehend and give informed consent for participating in the study

Exclusion criteria: :

 patient has received any dose of inhaled bronchodilators in the hour prior to enrollment

 patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment

 ventilated patients, while ventilated

 chest skin lesions

 cystic fibrosis

 hemodynamic instability

 patient's parent/guardian objects to the study protocol

 concurrent participation in any other clinical study

 physician objection


Trastuzumab in Treating Patients With Recurrent Osteosarcoma

Summary: RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.~PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have recurrent osteosarcoma.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin

 Measurable disease

 Immunohistochemical evidence of 2+ overexpression of HER2

 PATIENT CHARACTERISTICS:

 Age:

 Any age

 Performance status:

 Karnofsky 80-100%

 Life expectancy:

 Not specified

 Hematopoietic:

 Not specified

 Hepatic:

 ALT or AST less than 3 times upper limit of normal (ULN)

 Bilirubin less than 1.5 times ULN

 Renal:

 Creatinine less than 1.5 times ULN OR

 Creatinine clearance greater than 60 mL/min

 Cardiovascular:

 Fractional shortening at least 29% by echocardiogram OR

 Ejection fraction at least 50% by MUGA

 No prior cardiac dysfunction, even if presently controlled

 Other:

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 Not specified

 Chemotherapy:

 See Disease Characteristics

 At least 4 weeks since prior chemotherapy

 No prior anthracycline more than 450 mg/m^2

 Endocrine therapy:

 Not specified

 Radiotherapy:

 Not specified

 Surgery:

 Not specified

 Other:

 No other concurrent cancer therapy
Exclusion criteria:


A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients

Summary: The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients.
Inclusion criteria: inclusion criteria:

 Patients who are 18 years or older with a clinical or genetic diagnosis of FAP or attenuated FAP.

 Presence of duodenal polyps with a sum of diameters ≥ 5mm.

 Minimum of two weeks since any major surgery

 WHO performance status ≤1

 Adequate bone marrow function as show by: normal leukocyte count, platelet count ≥ 120 x 109/L, Hgb > 12 g/dL

 Adequate liver function as shown by: normal serum bilirubin(≤ 1.5 Upper Limit Normal {ULN}) and serum transaminases (≤ 2.0 ULN)

 Patient must discontinue taking any Nonsteroidal anti-inflammatory drugs (NSAIDS) within one month of treatment initiation.

 Patients must be able to provide written informed consent.

Exclusion criteria: :

 Prior treatment with any investigational drug within the preceding 4 weeks.

 Malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skins.

 Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study as determined by the Principal Investigator such as:

 Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia

 Severely impaired lung function

 Any active (acute or chronic) or uncontrolled infection/ disorders.

 Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy

 Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis

 Screening clinical laboratory values that indicate any of the following:

 anemia

 thrombocytopenia

 leucopenia

 elevations of transaminases greater than 2X ULN

 elevation of bilirubin > 1.5 X ULN

 alkaline phosphatase elevation > 1.5 X ULN

 increased creatinine, urinary protein, or urinary casts outside the clinically normal range.

 Gastrointestinal bleeding (symptoms including dyspnea, fatigue, angina, weakness, malaise, melena, hematochezia, hematemesis, anemia or abdominal pain will require clinical assessment to rule out gastrointestinal bleeding).

 Patient who is currently taking any anti-coagulation medication.

 Women who are pregnant or breast feeding.

 Patients with a known hypersensitivity to sulindac or erlotinib or to their excipients

['Erlotinib', 'Sulindac', 'Placebo A', 'Placebo B']


Management of Drug Hypersensitivity in Children

Summary: The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing HLA typing and a gene expression profile both in the acute phase of the reaction and 2 months later.
Inclusion criteria: inclusion criteria:

 Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake.

Exclusion criteria: :

 Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy).


Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers

Summary: Clinical Trial Phase III-b~Study Sponsor:~European Egyptian Pharmaceutical Industries~Sample Size:~120 patients (60 per arm)~Study Population:~Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed. Those patients will be recruited from patients attending the Diabetic foot Center at Faculty of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo University.~Recruitment Period: 9 months~Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the ulcer.~Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment whichever comes first
Inclusion criteria: inclusion criteria:

 Adult diabetic foot syndrome subjects over 18 years of age of any sex

 All stages of diabetic foot syndrome including Wagner stage 5 - Mid-foot gangrene only after appropriate surgical treatment.

 Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome.

 Stable metabolic and pharmacological control at recruitment and during the trial period.

 Adequate perfusion of lower limb as measured by HHD and confirmed by APSV.

Exclusion criteria: :

 Non-diabetic foot ulceration (traumatic, thermal ulceration etc)

 Diabetic foot syndrome graded 5 on Wagner's scale - hind foot gangrene only.

 Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure

 Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized.

 Presence of slough or sequestrum unless debrided.

 Hemoglobin less than 8 g/dl unless corrected.

 Those receiving NSAIDs, steroids or anti-mitotic drugs.

 Septicemia patients requiring urgent amputation.

['Royal Jelly and Panthenol (PedyPhar® Ointment)', 'Panthenol Ointment']


Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia

Summary: The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.
Inclusion criteria: inclusion criteria:

 Asymptomatic subjects aged 45 - 75 years

 Subjects who will give the written consent

Exclusion criteria: :

 Subjects with past history of colorectal cancer

 Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC)

 Subjects with familial history of colorectal cancer more than 2 familial member in direct line

 Subjects with inflammatory bowel disease(IBD)

 Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification

 Subjects with past history of colectomy

 Subjects with history of colonoscopy within 5 years

 Subjects with history of sigmoidoscopy within 3 years

 Subjects with history of CT colonoscopy within 10 years

 Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months


Menstrual Effects On Mood Symptoms in Bipolar Disorder

Summary: Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization. Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but confirmatory research is lacking.~Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have: 1) a) increased severity and persistence of depression and mania symptoms in the late luteal (premenstrual) vs early follicular phase, b) larger change in mood symptoms from the late luteal (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in the late luteal compared to the early follicular phase. The secondary aims are to determine: 1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory vs anovulatory cycles, c) antimanic drug treatment.
Inclusion criteria: inclusion criteria:

 Ages 18-45;

 Bipolar Disorder (BD) I or II (DSM-IV criteria) must agrees to communication between PI and Psychiatrist;

 Healthy Control without Past or Current Major Depression, Psychotic Disorder, premenstrual syndrome or Premenstrual Dysphoric Disorder;

 25-31day menstrual cycles;

 Minimum 6 menstrual cycles per year

Exclusion criteria: :

 Current DSM-IV Criteria Alcohol or Substance Abuse/Dependence;

 Pregnancy;

 Chronic Anovulation (<4 menstrual cycles/yr);

 Menopause (< 1menses in 1yr);

 Active thyroid disease;

 Hormonal Contraception


Multi-arm Intervention Diabetes Adherence Study

Summary: The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control.
Inclusion criteria: inclusion criteria:

 At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month.

 At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months.

 Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d

 Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that include both medical and pharmacy coverage.

Exclusion criteria: :

 Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period.

 Participation in a disease management program

['Adherence information', 'Adherence information plus motivational interviewing']


The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia

Summary: Dengue infection has been identified as the fastest spreading mosquito-borne viral disease by World Health Organization (WHO), which affects more than 2.5 billion people living in the subtropical and tropical regions. Malaysia is hyper-endemic with all four dengue virus serotypes circulating and responsible for the escalating number of cases over the years. As of 28 February 2015, there are 62 deaths secondary to dengue infection being reported in Malaysia; and the total number of dengue cases reported in the same period was 23,966 which is 46% higher than the same reporting period of 2014. Although dengue virus has been identified for so many years and plenty of research work has been carried out, it was proven that there are still many aspects that we are not too sure about the disease. Therefore, this multi-center, observational cohort study is designed to investigate the clinical course of hospitalized dengue infection in Malaysia. The study population of this study consists of male or female patients with dengue to be randomly sampled from hospitals in Malaysia. This study will be conducted in 2 stages whereby the 1st stage will only focus on the basic social and clinical data to describe the clinical course of dengue as general and the 2nd stage will collect the more detailed clinical and management data to describe the detailed clinical course, management and prognosis of dengue. All hospital participation in this study is voluntary, and approval will be obtained from National Institute of Health (NIH) and Medical Research Ethics Committee (MREC) prior to any recruitment.
Inclusion criteria: inclusion criteria:

 Stage 1:

 Discharge diagnosis with International Classification of Disease (ICD) code A90 - A99

 Availability of minimal dataset (name, IC, age, sex, diagnosis, date admit, date discharge, discharge status)

 Stage 2:

 Laboratory confirmed dengue (Non-structural 1 antigen, dengue IgM, high-titre dengue IgG, and dengue polymerase chain reaction (PCR) positive)

Exclusion criteria: :

 Nil


Lyme Disease Prevention Program

Summary: This is a large study of an educational program on Lyme disease prevention for passengers on ferry boats going to Nantucket Island during the period from Memorial Day until Labor Day. Some boats provide passengers with the experimental program and the other boats provide a control program that the researchers can compare to the experimental program. The experimental program uses live performances by entertainers to teach people about Lyme disease prevention, and also uses additional printed materials. People on the control boats receive education on injury prevention and road safety while bicycling, rollerblading, and using mopeds. The main result we will look for is Lyme disease identified by a followup survey and confirmed by reviewing medical records. We will also ask some people to take part in a smaller study of behavior change. In this study, we will ask people to complete forms on self-efficacy (a person's belief in his or her ability to reach a certain goal), their plans to take preventive steps, and actual prevention behaviors. We also ask participants who report doctor visits or illness to provide confirmation of their use of health services.
Inclusion criteria: inclusion criteria:

 Ferry passengers traveling to Nantucket Island

Exclusion criteria: :

 Foreign (non-U.S.) residence


Michigan Driver Education Study

Summary: Teens are at high risk for traffic violations and car crashes because of their young age, lack of driving experience, and exposure to high-risk driving conditions. The Checkpoints Program has used increased parental restrictions on teen driving through at least the first 4 months after their children obtain a driver's permit.~The purpose of this study is to evaluate the efficacy of the Checkpoints Program.~Approximately 400 teens in Michigan will participate in one of two study groups. One group will take standard driver education classes; the other group will take driver education classes that incorporate the Checkpoints Program. Teens and their parents will complete a written survey after completing the classes and a telephone survey after teens obtain a driver's permit. Teens will complete additional telephone surveys 1, 3, 6, and 12 months after obtaining a driver's permit. Researchers will use this information to study how parents manage teen driving practices, teen driving experiences (amount and conditions of), and high-risk teen driving behaviors.
Inclusion criteria: inclusion criteria:

 Teens between the ages of 15 years 0 months and 16 years 6 months enrolled in a licensed driver education course are eligible to participate.

Exclusion criteria: :

 Adolescents over the age of 16 years 6 months or those whose parent or legal guardian does not attend the driver education course session to which they are specifically invited will be deemed ineligible for the study.


Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Summary: This study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.
Inclusion criteria: inclusion criteria:

 Age over 18 years

 planned CABG or valvular surgery with cardiopulmonary bypass

 Serum creatinine available (within 30 days)

 Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4)

Exclusion criteria: :

 Emergent or urgent surgery (to be performed within the next 36 hours)

 End stage renal disease, or GFR < 15ml/min (CKD stage 5)

 Estimated GFR>90ml/min (CKD stage 1 or no CKD)

 Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR

 Allergy to minocycline or tetracyclines

 inability to take oral medications

 use of preoperative vasopressor agents at therapeutic doses

 Pregnant or lactating females

 Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice)

 Rising creatinine meeting the definition of acute kidney injury prior to surgery

 Neurologic signs or symptoms or history of increased intracranial pressure

 current participation in another research study involving an investigational drug or device

['Kidney Failure, Acute', 'Acute Kidney Insufficiency']

Kidney Failure
Acute
Acute Kidney Insufficiency


Phase I Study of ETEC Vaccine

Summary: The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli infection) is safe. This vaccine will be tested to see what effects it has on the body and the ability of the vaccine to help the body resist disease. Researchers want to find the highest dose of dmLT vaccine that can be given without causing severe side effects. Most E. coli bacteria are harmless to humans and can even be beneficial. However, some are harmful, and can cause diarrhea. About 32 healthy adults, ages 18-45, will participate in this study. This study will require volunteers to stay in the research facility for several nights. Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures include: stool samples, blood samples, and documenting side effects. Participants will be involved in study related procedures for about 8 months.
Inclusion criteria: inclusion criteria:

 Male or female ages 18-45, inclusive.

 Provide written informed consent before initiation of any study procedures.

 Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, and medication history.

 Within 45 days of vaccination, have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), prothrombin time (PT), partial thromboplastin time (PTT), International Normalized Ratio (INR), C-reactive protein (CRP), and fibrinogen as defined in Appendix B.

 Have normal screening laboratories for urine protein and urine glucose.

 Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 70 percent).

 Capable of understanding, consenting and complying with the entire study protocol including the inpatient period.

 Female subjects must be of non-childbearing potential, (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control (e.g., history of hysterectomy or tubal ligation; use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), cervical sponges, diaphragms, condoms with spermicidal agents, or must have a vasectomized partner) within 2 months of vaccination and must agree to continue such precautions during the study and for 30 days after the Day 28 study visit. Male subjects must agree not to father a child for 90 days after the Day 0 study visit. A woman is eligible if she is monogamous with a vasectomized male.

 Agrees not to participate in another clinical trial during the study period.

 Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine.

Exclusion criteria: :

 Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test upon admission to inpatient facility.

 Abnormal Vital signs, defined as:

 Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or (heart rate <55 at rest on 2 separate days) Respiratory rate >17

 Temperature >/= 38.0 C (100.4 F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of administration of dmLT.

 Active positive Hepatitis B, C, and Human Immunodeficiency Virus (HIV) serologies.

 Have a positive urine drug screen.

 Subjects who are unwilling or unable to cease smoking for the duration of the inpatient stay.

 History of antimicrobial treatment in the 2 weeks before ingestion of dmLT.

 Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholerae challenges; or previous infection with cholera or diarrheagenic E. coli.

 Abnormal bowel habits as defined by fewer than 3 stools per week or more than 2 stools per day in the past 6 months.

 History of chronic gastrointestinal illness, including severe dyspepsia (mild or moderate heartburn or epigastric pain occurring no more than 3 times per week is permitted), lactose intolerance, or other significant gastrointestinal tract disease.

 Regular use (weekly or more often) of laxatives, anti-diarrheal, anti-constipation, or antacid therapy.

 History of major gastrointestinal surgery, excluding uncomplicated appendectomy or cholecystectomy.

 Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).

 Have a diagnosis of schizophrenia or other major psychiatric diagnosis.

 Receiving the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate.

 NOTE: Subjects who are receiving a single antidepressant drug and are stable for at least 3 months before enrollment without de-compensating symptoms, will be allowed to be enrolled in the study.

 History of receiving immunoglobulin or other blood product within the 3 months before enrollment in this study.

 Traveled to certain Enterotoxigenic Escherichia coli (ETEC) endemic areas within the past 3 years or raised in a cholera or ETEC endemic area.

 Received any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) before enrollment in this study.

 An acute or chronic medical condition that, in the opinion of the investigator, would render ingestion of dmLT unsafe or would interfere with the evaluation of responses. This includes, but is not limited to: known or suspected immunodeficiency, known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, history of diabetes, cancer (other than a healed skin lesion), heart disease (in the hospital for a heart attack, history of irregular heart beat or fainting caused by an irregular heart beat), unconsciousness (other than a single brief concussion), seizures (other than with fever when subject was a child <5 years old), asthma requiring treatment with inhaler or medication in the prior 2 years, autoimmune disease or eating disorder, and transplant recipients.

 Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study.

 History of alcohol or drug abuse in the last 5 years.

 Planned to travel outside of the USA in the time between vaccination and 28 days following the vaccination.

 Unable to spend 4 days as an inpatient.

 Any condition that would, in the opinion of the Site Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

 Use of prescription and over-the-counter (OTC) medications that contain acetaminophen, aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs within 48 hours prior to receiving the investigational product.

 Use of prescription acid suppression medication or OTC antacids within 72 hours of investigational product administration.

 Subjects with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation.

 Subjects who plan to travel to an ETEC endemic area during the long-term safety follow-up period (6 months) of the study.

['Double Mutant Heat- Labile Toxin (dmLT)']


Genetic Susceptibility to Rheumatic Heart Disease in the Pacific Region

Summary: The purpose of this study is to investigate whether there are genetic differences between patients with rheumatic heart disease and members of the general population.
Inclusion criteria: Cases

 inclusion criteria:

 Diagnosis of rheumatic heart disease based on one of:

 World Heart Federation definite echocardiographic criteria

 World Heart Federation borderline echocardiographic criteria and history of acute rheumatic fever

 Mitral stenosis with valve area less than 2.0 cm2

 Previous surgery for rheumatic heart disease

Exclusion criteria: :

 Age less than five years

 Inability to give consent

 New Controls

 inclusion criteria:

 Healthy individual living in a community where cases were identified

['Rheumatic Heart Disease', 'Mitral Stenosis']


Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Summary: This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.~The study has 2 groups.~One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).~The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.~All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).
Inclusion criteria: inclusion criteria:

 Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.

 Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

 Written informed consent obtained from the parent or guardian of the subject.

 Free of obvious health problems as established by medical history and clinical examination before entering into the study.

 Born after a gestation period between 36 and 42 weeks.

Exclusion criteria: :

 Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period

 Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

 Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.

 Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations

 History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.

 History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

 History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.

 Acute disease at the time of enrolment

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

 A family history of congenital or hereditary immunodeficiency.

 Major congenital defects or serious chronic illness.

 Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.

['Pneumococcal conjugate vaccine GSK1024850A', 'Prevenar', 'Tritanrix-HepB', 'Hiberix', 'Polio Sabin.', 'Poliorix.']


Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

Summary: To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.
Inclusion criteria: Elderly men and women with atrial fibrillation and other risk factors for stroke.
Exclusion criteria:

['amiodarone', 'sotalol', 'propafenone', 'flecainide', 'quinidine', 'moricizine', 'disopyramide', 'procainamide', 'adrenergic beta antagonists', 'verapamil', 'diltiazem', 'digoxin', 'catheter ablation', 'pacemaker, artificial']

amiodarone
sotalol
propafenone
flecainide
quinidine
moricizine
disopyramide
procainamide
adrenergic beta antagonists
verapamil
diltiazem
digoxin
catheter ablation
pacemaker
artificial

['Arrhythmia', 'Atrial Fibrillation', 'Cardiovascular Diseases', 'Heart Diseases']

Arrhythmia
Atrial Fibrillation
Cardiovascular Diseases
Heart Diseases


Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans

Summary: The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.
Inclusion criteria: inclusion criteria:

 Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.

 Men or women 18 years and older of African American background; self identified

 Patients with stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization)

Exclusion criteria: :

 Office blood pressure measured by cuff (MSSBP ≥ 200 mmHg and/or MSDBP ≥ 110 mmHg) at any visit.

 Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer.

 History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (CCBs or thiazide diuretics) as the study drugs.

 Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.

 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

 Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)

 Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.

 Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.

 Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.

 History or evidence of a secondary form of hypertension.

 Known Keith-Wagener Grade III or IV hypertensive retinopathy.

 History of cerebrovascular accident, transient ischemic cerebral attack (TIA), heart failure (NYHA Class II-IV), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) in the last 12 months.

 Current angina pectoris requiring pharmacological therapy.

 Other protocol-defined inclusion/

['Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks', 'Amlodipine: 8 weeks']


Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease

Summary: The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.
Inclusion criteria: inclusion criteria:

 Women 9-26 years of age

 Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)

Exclusion criteria: :

 Pregnancy

 Taking corticosteroids

 Allergy to yeast aluminum component of the HPV vaccine

 Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18

['Inflammatory Bowel Disease', 'Uterine Cervical Dysplasia']

Inflammatory Bowel Disease
Uterine Cervical Dysplasia


Effect of Exercise on Risk-factors of Elderly Women

Summary: The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.
Inclusion criteria: inclusion criteria:

 Community living Caucasian woman ≥ 65 years; live expectation > 2 years

Exclusion criteria: :

 secondary osteoporosis

 CVD-events including stroke

 Participation in other studies

 Medication with impact on bone during the last 2 years:

 bisphosphonates

 parathormone

 strontium

 HRT, anabolic steroids

 calcitonin

 natriumflourides

 active Vit-D-metabolites

 cortisone > 5 mg/d

 medication with impact on falls

 low physical performance (<50 Watt during ergometry)

 excessive alcohol-intake


Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist

Summary: Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such medication can only be given short-term and has inconvenient side effects such as hot-flushes. Thus, many women with symptomatic fibroids choose to have them removed surgically, either individually or by removing the uterus via hysterectomy.~The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914. A similar compound, mifepristone (Registered Trademark), reduced fibroid size when given for twelve weeks. This study will compare fibroid size, hormone levels and symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or placebo for 10 - 14 weeks. To do this, women will undergo MRI and a saline hysterosonogram (ultrasound with fluid) of the uterus before and at the end of the treatment; they will have blood drawn every 7 - 14 days, and will fill out a symptom calendar at home. Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues, and to provide treatment for the study participant. Women will be randomly assigned to the treatment groups; during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives.~...
Inclusion criteria: GENERAL inclusion criteria:

 Women receiving insulin or thyroid hormone replacement may participate if well-controlled; use of vitamins and calcium under RDA is allowed.

 Female gender-to evaluate effects in the target population for clinical trials.

 In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the counter drugs is acceptable but must be recorded.

 Menstrual cycles of 24 - 35 days.

 Hemoglobin greater than 10 g/dL.

 Willing and able to comply with study requirements.

 Age 33 to 50.

 Using mechanical (condoms, diaphragms), sterilization or abstinence methods of contraception for the duration of the study.

 Negative urine pregnancy test.

 BMI less than or equal to 33.

 Able to read and speak English fluently to allow accurate self-administration of medication, recording of symptoms and unassisted completion of questionnaire.

 Normal glomerular filtration rate.

 Liver function tests within 130% of upper limit.

 inclusion criteria FOR WOMEN WITH LEIOMYOMA:

 History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the ACOG practice bulletin (ACOG Practice Bulletin 1994):

 Excessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss; OR

 Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection.

 Uterine leiomyoma(ta) of at least 2 cm size.

 No desire for fertility; willing to undergo hysterectomy.

 GENERAL
Exclusion criteria: :

 Significant abnormalities in the history, physical or laboratory examination.

 Pregnancy.

 Lactation.

 Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year.

 Unexplained vaginal bleeding.

 History of malignancy within the past 5 years.

 Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations.

 Use of agents known to induct hepatic P450 enzymes; use of imidazoles.

 Current use of GnRH analogs or other compounds that affect menstrual cyclicity.

 FSH greater than 20 IU/mL.

 Significant medical disorders.

 Cervical dysplasia.

 Need for interval use of narcotics.

 Abnormal adnexal/ovarian mass.

 Intrauterine device.


Cyclophosphamide and Fludarabine to Treat Lupus Nephritis

Summary: This study will test the safety and effectiveness of combination therapy with cyclophosphamide (Cytoxan) and fludarabine in treating lupus nephritis (kidney inflammation). This condition, common in patients with systemic lupus erythematosus, is caused by abnormal action of immune cells called lymphocytes against the kidneys. Left untreated, severe cases can result in loss of kidney function. The current treatment of choice-intermittent high doses (pulses) of cyclophosphamide-does not work in all patients and causes infertility in many women. The rate of infertility in men is not known. This study will examine whether fludarabine can safely be given with significantly lower doses of cyclophosphamide, and if this combination controls kidney inflammation.~Patients 18 years of age and older with severe lupus nephritis (called proliferative lupus nephritis) may be eligible for this study. Candidates will have a history and physical examination; blood and urine tests; chest X-ray; electrocardiogram; cancer screening that may include a Pap smear, mammogram, rectal examination, PSA testing, and sigmoidoscopy.~Participants will be divided into one of the following treatment groups:~Group 1-Patients undergo three treatment cycles of cyclophosphamide, taken by mouth, and fludarabine, injected subcutaneously (under the skin). Patients receive both drugs on day 1 of the cycle, and fludarabine alone on days 2 and 3. This regimen is repeated once every 5 weeks for three cycles.~Group 2-Same as for Group 1, except fludarabine injections are given intravenously (through a vein) for the second treatment cycle. Patients in this group have frequent blood sampling during the first and second treatment cycles to monitor blood levels of the drug. Samples are collected before the first injection is given and at 0.5, 1, 1.5, 2, 4, 8, 24 and 48 hours after the third injection. A total 12 tablespoons of blood is drawn over a 2-month period.~All patients will have blood drawn once or twice a week during the first two cycles and then less frequently to monitor blood counts. Some patients will have the following additional procedures to test the effects of treatment on lymphocytes:~Blood sample collection~Bone marrow aspiration-The skin over the hip bone is cleaned and a local anesthetic is injected into the outer covering of the bone. Bone marrow is suctioned through the needle into an attached syringe. The procedure is done before treatment begins, at the end of treatment, and 6 months after treatment.~Tonsillar biopsy-The tonsils are numbed with a local anesthetic and 1 to 4 pieces of tissue are removed using special forceps. The procedure is done before treatment begins, at the end of treatment, and 6 months after treatment.~Magnetic resonance imaging (MRI) of the abdomen-The patients lies on a table in a narrow cylinder (the MRI scanner) containing a strong magnetic field, which is used to create images of parts of the body in small section views.~Patients will be followed for at least 24 months to monitor late side effects and the response to treatment.
Inclusion criteria: Patients must be 18 years of age or older and able to provide informed consent.

 Patients must have at least 4 criteria for SLE as defined by the American Rheumatism Association (ARA).

 Active glomerulonephritis with:

 Renal biopsy within 1 year with class III or class IV active lupus nephritis, AND;

 Abnormal urine analysis:

 Greater than 10 RBC/hpf and cellular (RBC, WBC or mixed) casts, OR;

 Greater than 10 RBC/hpf and proteinuria greater than 2 g/day, OR;

 Proteinuria greater than 3.5 g/day.

 No patients with severe proliferative lupus nephritis: a. very active renal histology with crescents or necrosis in more than 25% of glomeruli; or b. rapidly progressive glomerulonephritis (doubling of serum creatinine in less than or equal to 3 months); or c. severe impairment of renal function Cr greater than 2.5 mg/dL or GFR less than 50 mL/min measured by inulin clearance.

 Patient has not had previous immunosuppressive therapy:

 Patients must not be receiving azathioprine, cyclosporine, methotrexate. Patients receiving these drugs will be eligible only if these drugs are discontinued and after a waiting period of greater than or equal to 4 weeks;

 Patients must not be receiving cyclophosphamide:

 Greater than 3 pulses (maximum 1 g/m(2)/pulse) within the last 12 months or since last renal biopsy showing active disease; OR

 greater than 6 pulses ever.

 Patients must not have had pulse therapy with glucocorticoids or any experimental therapy during the 4 weeks before study entry.

 Patients who need at study entry oral corticosteroids in dosages greater than 0.5 mg/kg/day of predisone to control extrarenal disease are not eligible.

 Patients with active or chronic infection are not eligible.

 Patients who are pregnant, breast-feeding or using inadequate birth control are not eligible.

 Patients who have poorly controlled diabetes mellitus or with evidence of end-organ damage are not eligible.

 No history of cerebrovascular accident, seizures within the last 5 years or chronic neurologic disease.

 No history of malignancy other than squamous cell and/or basal carcinoma of the skin.

 No confounding medical illness that in the judgment of investigators would pose added risk for study participants such as:

 Unstable coronary artery disease, cardiomyopathy or dysrhythmia requiring therapy;

 Pulmonary disease (PFTs less 70% of predicted value or DLCO less than 60%), or;

 Hematologic disease (Hb less than 8 mg/dL, platelets less than 100,000 micro liters or WBC less than 2,500/micro liters.
Exclusion criteria:

['Glomerulonephritis', 'Lupus Nephritis', 'Systemic Lupus Erythematosus']

Glomerulonephritis
Lupus Nephritis
Systemic Lupus Erythematosus


A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia

Summary: The purpose of this study is to explore the safety and tolerability and the efficacy of galantamine treatment in subjects with Pick Complex/ Frontotemporal Dementia (PC/FTD). The safety and tolerability of galantamine therapy will be assessed over the entire treatment period (26 weeks). The 8 week withdrawal period will be used to confirm the safety of galantamine withdrawal in this subject group and it impact on any symptom improvement achieved during the first 18 weeks of galantamine treatment ( symptom improvement would be expected to stabilize or decline on withdrawal of an effective therapy).~The primary efficacy objective is to explore the effect of galantamine on behavior as measured by the Frontal Behavioral Inventory during the randomized withdrawal period. In addition, for subjects with primary progressive aphasia (limited ability for languages), the effects of galantamine on language will be explored using the Aphasia Quotient of the Western Aphasia Battery, and for all subjects the Clinical Global Impressions will be used to explore global change.
Inclusion criteria: inclusion criteria:

 Outpatients with a clinical diagnosis of Frontotemporal Dementia or Pick Complex (PC/FTD) documented for at least 1 year with either primary progressive aphasia or frontotemporal dementia

 recent MRI or CT confirming frontotemporal lobar atrophy consistent with Frontotemporal Dementia or Pick Complex PC/FTD

 opportunity to perform certain activities of daily living as described in the Alzheimer's Disease Cooperative Study -- Activities of Daily Living Inventory

 living with or having regular visits (least 4 days/week) from a responsible caregiver

 Mini Mental State Examination score > 5 and the ability to complete baseline neuropsychometric testing

 able to see, hear, and communicate sufficiently, and willing to complete serial neuropsychometric tests

 female subjects of childbearing age must be surgically sterile or practicing an effective method of birth control before entry and throughout the study.

Exclusion criteria: :

 No neurodegenerative disorders and other causes of dementia or cognitive impairment from acute cerebral injuries, cerebrovascular disease or hypoxic cerebral damage, vitamin deficiency states, infection cerebral neoplasia

 no primary memory disturbance or an amnestic syndrome more compatible with Alzheimer's disease or other primary degenerative dementia

 no uncontrolled epilepsy or clinically significant psychiatric disease, cardiovascular disease, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, active peptic ulcer and urinary outflow obstruction

 no use of any agent used for the treatment of dementia or other cognitive impairment

 no history of severe drug allergy or hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide

['Frontotemporal Dementia', 'Pick Complex']


Postpartum Intrauterine Device Study

Summary: The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.~The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.
Inclusion criteria: inclusion criteria:

 Primary inclusion criteria:

 Ages 18-45 attending prenatal care

 Greater than 34 weeks estimated gestational age

 Desire to use the CuT380A-IUCD for contraception postpartum

 Plan to stay in the area for at least 5 months postpartum

 If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport

 No prior cesarean delivery

 No treatment for pelvic inflammatory disease within 3 months prior to pregnancy

 No known uterine anomalies

 No known pelvic tuberculosis

 No known genital tract cancer

 No known allergy to copper

 No known history of ectopic pregnancy within 3 months prior to pregnancy.

 No evidence of clinical anemia as assessed by a clinician at enrollment

 Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery

 Secondary Eligibility Criteria

 Vaginal delivery within the last 48 hours

 No postpartum hemorrhage documented by the delivering clinician

 Not known to have ruptured membranes for greater than 24 hours prior to delivery

 No infection diagnosed by a clinician

 No fever of greater than 38° during labour or delivery

 Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery.

Exclusion criteria: :

 prior cesarean section

 fever during labor and delivery

 AIDS, not well on antiretroviral therapy

 genital tuberculosis

 known uterine abnormalities or genital tract cancer

 history of ectopic pregnancy within 3 months of current pregnancy

['Africa', 'Contraception', 'Intrauterine Devices', 'Pilot Study']

Africa
Contraception
Intrauterine Devices
Pilot Study


Efficacy Study of Korean Red Ginseng to Treat Depression

Summary: The purpose of this study is to determine whether Korean Red Ginseng are effective in the treatment of the residual symptoms of depression as an adjuvant treatment.
Inclusion criteria: inclusion criteria:

 Outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder.

 Those who are in remission, which is defined as a MADRS score 8 on two consecutive visits at a 4-week interval.

 Their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of Korean red ginseng for residual symptoms.

Exclusion criteria: :

 Those who have a history of substance abuse or dependence within 1 month.

 Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results.

 Those who have a past history of hypersensitivity or intolerance to Korean red ginseng.

 Those who participated in clinical trials within 1 month before entering the study entry.

 Those who are pregnant or are breast feeding.

 Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study.

 The patients unable/unlikely to comprehend/follow the protocol.


Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer.

Summary: Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.
Inclusion criteria: inclusion criteria:

 oesophageal cancer

 Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery

Exclusion criteria: :

 Metastatic disease

['DEXA scan', 'Muscle biopsy', 'cardio-pulmonary exercise testing (CPEX)']


A Study to Evaluate the Effectiveness of STELARA ™ (USTEKINUMAB) in the Treatment of Scalp Psoriasis

Summary: This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp specific physician assessments. The study will include approximately 30 subjects.
Inclusion criteria: inclusion criteria:

 Capable of giving informed consent and the consent must be obtained prior to any study related procedures.

 Be 18 years of age or older at the time of consent; may be male or female.

 Have had a diagnosis of plaque psoriasis at least 6 months prior to administration of study agent.

 Presence of moderate or severe psoriasis on the body other than the scalp.

 At least 30% of scalp affected with erythema, induration and desquamation and s-PGA score greater than or equal to 4.

 Be candidates for phototherapy or systemic treatment of psoriasis.

 Women of childbearing potential and all men must be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue use of such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent.

 Be able to adhere to protocol requirements and study visit schedule.

 Must agree not to receive a live virus or live bacterial vaccination during the trial and 12 months after last study injection.

 Must agree not to receive a BCG vaccination during the trial and up to 12 months after the last injection.

 Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.

 Are considered eligible according to the following tuberculosis (TB) screening criteria:

 Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.

 Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.

 Within 6 weeks prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result (see Attachment #).Indeterminate results should be handled as outlined in Section #,
Exclusion criteria: .

 Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.

 Have screening laboratory test results within the following parameters:

 Hemoglobin > 10g/dL

 White Blood Cells > 3.5 x 109 /L

 Neutrophils > 1.5 x 109 /L

 Platelets > 100 X109 /L

 Serum Creatinine < 1.5 mg/dL ( or 133 micromol/L )

 AST,ALT, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range for the laboratory conducting the test


PATH-2: Platelet Rich Plasma in Achilles Tendon Healing

Summary: Platelet Rich Plasma in Achilles Tendon Healing~Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit patients aged 18 or over who are suitable for nonsurgical treatment of the Achilles tendon rupture (ATR)? This is a multicentre, blinded, randomised, placebo controlled trial with two sub studies: (1) blood sample analysis and (2) needle biopsy in 16 participants.~ATR is the most common tendon injury and leads to months of incapacity. With an average work absence of 63108 days there are significant societal and National Health Service (NHS) costs. PRP potential benefit is to improve recovery and return to normal activities earlier, and reduce the NHS and societal impact. The investigators will investigate the efficacy of PRP using disease specific and patient important outcomes to improve the evidence for this treatment of ATR.~A minimum of 15 United Kingdom (UK) NHS hospitals will be included to recruit 214 participants. Patients will be identified in the orthopaedic outpatient clinic, usually following an emergency hospital attendance for ATR. After checking eligibility and the informed consent process, baseline data is collected and participants randomised to either 'PRP injection' or 'Imitation (placebo) injection'. A participant's own blood sample is taken and prepared according to allocation. The injection is delivered by a trained surgeon in clinic who will be aware of allocation while the participant remains blind.~Participants complete a pain diary and have four study assessments at 4,7,13 and 24 weeks, carried out by a member of the research team blind to allocation. Assessments take place over the telephone or during a hospital outpatient visit. The 24 week hospital visit includes an exercise test of ankle function. All assessments include collection of patient reported responses to pre-set questions.~The results may be applicable to the many other tendon and ligament injuries. The National Institute for Health Research (NIHR)/Medical Research Council (MRC) Efficacy and Mechanism Evaluation Programme provides funding and University of Oxford is Sponsor.
Inclusion criteria: inclusion criteria:

 Patient is willing and able to give informed consent for participation in the study

 Aged 18 years or over

 Ambulatory prior to injury without the use of walking aids or assistance of another person

 Diagnosed with an acute, complete, Achilles tendon rupture

 Presenting within and receiving study treatment within 12 days post injury

 Patients in whom the decision has been made for non-operative treatment

 Able (in the Investigator's opinion) and willing to comply with all study requirements

 Able to attend a PATH-2 study hospital site for the 24-week follow-up.

Exclusion criteria: :

 The patient may not enter the study if any of the following apply:

 Achilles tendon injuries at the insertion to the calcaneum or at the musculotendinous junction

 Previous major tendon or ankle injury or deformity to either lower leg

 History of diabetes mellitus

 Known platelet abnormality or haematological disorder

 Current use of systemic cortisone or a treatment dose of an anticoagulant (i.e. a prophylactic dose for preventing thrombosis would not be an exclusion)

 Evidence of lower limb gangrene/ulcers or peripheral vascular disease

 History of hepatic or renal impairment or dialysis

 Female patients who are pregnant or breast feeding

 Is currently receiving or has received radiation or chemotherapy within the last 3 months

 Has inadequate venous access for drawing blood

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

['PRP Injection into Achilles tendon rupture gap', 'Imitation Injection into Achilles tendon rupture gap']


300 Antibody Diagnostic Test Kit

Summary: For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically normal serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.
Inclusion criteria: inclusion criteria:

 current acute infection

 age 18-70

 male or female

 any race

 currently active symptoms
Exclusion criteria:

['Acute Bacterial Infections', 'Acute Viral Infections']

Acute Bacterial Infections
Acute Viral Infections


Prescribe Exercise for Prevention of Falls and Fractures: A Family Health Team Approach

Summary: Falls and fractures are a leading cause of death and disability in the older adult population. The consequences of falls and fractures contribute substantially to health care costs and can have a significant negative impact on the quality of life of the individual. Exercise has been studied as an option to reduce fracture risk and prevent falls though improving balance and muscle strength. The prevention of falls is important, as a history of falls is strongly predictive of suffering another. Those who are at a high risk of fracture or falling require a patient specific assessment and individualized exercise prescription that is tailored to their needs. This kind of program may not be typically available within the community and at a low cost. These individuals may experience difficulty when trying to engage in exercise due to barriers such as a lack of transportation, and a lack of knowledge. As the first point of contact with the health care system for many family doctors are in the ideal position to deliver exercise advice to their patients. However, a lack of time and specialized skills in prescribing exercise make this difficult for many of them. As a result, family health teams who provide interdisciplinary patient centered care are becoming popular. In this model the care is shared and provided by the most appropriate team member (e.g. doctor, nurse, exercise specialist). Additionally, many exercise interventions do not include a behavior change aspect, which may be an important component when trying to get individuals to engage in a new health behavior like exercise. Therefore the purpose of this project is to assess the feasibility of implementing a tailored exercise program to those at high risk of falls or fractures over the age of 65 in a primary care setting using an interdisciplinary model of care that is based on a health behaviour change model.
Inclusion criteria: inclusion criteria:

 > age 65

 Patient of the Centre for Family Medicine Family Health Team (CFFM FHT)

 Have at least one of the following:

 2 or more falls in the past 12 months

 age 75 +

 high risk of fracture based on the CAROC

 difficulty with walking or balance as determined by attending physician

 acute fall

 history of a fragility fracture after the age of 50

Exclusion criteria: :

 moderate to severe cognitive impairment

 moderate to severe neurologic impairment

 not able to communicate in English

 contraindications to exercise as determined by physician

 uncontrolled hypertension

 palliative care, current cancer, on dialysis

 participation in a similar exercise program including resistance training at least 3 times a week

['Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes']

Identification of patients at risk
tailored exercise prescription
motivational interviewing
review of behavioural outcomes


Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome

Summary: The purpose of this study is to determine the change in kidney function and blood pressure after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.
Inclusion criteria: inclusion criteria:

 Morbid obesity (BMI>30) patients with one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension)

 Morbid obese patients (BMI>35)

Exclusion criteria: :

 Prior bariatric surgery

 Malignancy (any type)

 End stage renal disease

['Bariatric surgery', 'Intensive medical therapy']

Bariatric surgery
Intensive medical therapy


Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

Summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.~The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Inclusion criteria: inclusion criteria:

 A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).

 A woman between, and including, 15 and 25 years of age at the time of the first vaccination.

 Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent).

 Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study.

 Subject must have a negative urine pregnancy test.

 Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

 Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements.

 Subject must have intact cervix.

Exclusion criteria: :

 Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.

 A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8).

 Previous administration of components of the investigational vaccine.

 Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

 Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

 Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.

 Previous vaccination against human papillomavirus (HPV).

 History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease.

 History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.

 Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.

 History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.

 Hypersensitivity to latex.

 Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.

 History of chronic condition(s) requiring treatment.

 Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window.

 Acute disease at the time of enrolment.

 Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.

['Cervarix™', 'Havrix™-based investigational formulation']


Manual vs Amigo SmartTouch Atrial Fibrillation Study

Summary: Atrial fibrillation is a common form of heart rhythm disturbance that for some patients is treated by catheter ablation (making an ablation lesion or burn inside the heart using a fine wire (catheter)). A new system for manipulating the catheters has recently been introduced into clinical practice (the Amigo Remote Catheter System (RCS)). This trial is designed to answer two primary questions: a) is the contact force (the force with which the catheter comes into contact with the heart) any different using the RCS to manual techniques,and b)are the resulting ablation lesions within the heart any different in terms of the volume and contiguity of the lesions produced. Additionally the investigators aim to determine how the two techniques compare in success (the proportion of patients whose heart rhythm disturbance is corrected by the procedure).
Inclusion criteria: inclusion criteria:

 atrial fibrillation

 scheduled for catheter ablation

Exclusion criteria: :

 contraindication to magnetic resonance imaging

 pregnancy

 life expectancy of less than six months

 participation in another trial that would conflict with this trial

['Catheter ablation for atrial fibrillation, manual', 'Ablation using Amigo remote catheter system']


Biomarkers and Genetic Factors Related to Emphysema

Summary: Emphysema, a common type of chronic obstructive pulmonary disease (COPD), is a long-term lung disease that is usually caused by cigarette smoking. This study will examine both current smokers and former smokers who have emphysema, as well as current and former smokers who do not have emphysema, to determine if certain factors found in the blood are related to the risk of developing emphysema.
Inclusion criteria: inclusion criteria for All Participants:

 Able to read and write English

 At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years)

 Able to participate in the informed consent process

 Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry)

 inclusion criteria for Participants with Emphysema:

 Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR

 More than minimal emphysema on an acceptable-quality chest CT scan

 inclusion criteria for Participants without Emphysema:

 GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND

 No or minimal emphysema on an acceptable-quality chest CT scan

Exclusion criteria: :

 Pregnant

 Prisoner

 Vulnerable populations

 Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment)

 Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant

 Congenital abnormalities of the lung or previous lung surgery

 Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)

 CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)

['Emphysema', 'Pulmonary Disease, Chronic Obstructive']

Emphysema
Pulmonary Disease
Chronic Obstructive


Effects of a Worksite Parenting Program

Summary: Many adolescents in the U.S., even very young adolescents, are engaging in sexual risk behaviors that put them at risk for sexually transmitted diseases (STDs) and unintended pregnancy. Studies show that parents can play a significant role in promoting healthy sexual development and risk reduction among adolescents. The UCLA/RAND Center for Adolescent Health Promotion has developed Talking Parents, Healthy Teens, a worksite-based parenting program for parents of adolescents (grades 6-10) to improve parent-adolescent communication and reduce adolescent sexual risk behaviors. We are evaluating the effectiveness of the program primarily with confidential surveys of the participants before and after the program.
Inclusion criteria: inclusion criteria:

 Parents of adolescents in grades 6-10

 Parents must spend at least two days per week with their adolescents

 One parent per household/family
Exclusion criteria:


Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer

Summary: In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care. Patients with early stage PTC will be required to have surgical pathologic criteria for which adjuvant RAI treatment may be considered optional.
Inclusion criteria: inclusion criteria for patient participants:

 Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi- [subtotal] with completion thyroidectomy)on or after September 1, 2009

 Age at time of first thyroid cancer surgery must be at least 18 years or older

 The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report)

 Must be able to communicate in spoken and written English

 Must be able to use a computer

 Must be able to provide informed consent on one's own (without any need for translation)

Exclusion criteria:  for patient participants:

 Participants not meeting inclusion criteria

 Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma

 Prior radioactive treatment for thyroid cancer

 Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication.

 Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study

 inclusion criteria for the physician feedback component of this study:

 - Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada.