Empowered Sisters Project Making Choices Reducing Risks

Summary: The purpose of this study is to combine a culturally tailored and integrated Risk Reduction Intervention in the US Virgin Islands (USVI) in a clinical trial randomly assigning abused women to a 1) Healthy Relationships experimental group of three sessions of risk reduction interventions or 2) a Healthy Living comparison control group of three session of health promotion activities to determine if the combined, intervention is safe and effective in a test the following hypotheses:~Women in the integrated risk reduction intervention will score significantly lower on outcome measures of intimate partner abuse (IPA) and STD/HIV risk behaviors end of Session III and at 3 and 6 months than women in the control group~Women in the integrated risk reduction Intervention will score significantly higher on IPA safety behaviors and STI/HIV prevention behaviors at end of Session III and at 3 and 6 months than women in the control group.~Several exploratory and major controlled studies on the mainland US have shown intimate partner violence (IPV) and intimate partner abuse (IPA) to be risk factors for a variety of physical, reproductive and mental health problems, including sexually transmitted infections and HIV/AIDS, many of which are areas of known health disparity for African American and Latina women. A recently completed study of African Caribbean and African American women in the US Virgin Islands revealed that nearly one third of women reported lifetime partner abuse and increased risk for sexually transmitted infections including HIV/AIDS. Abused women in the USVI had significantly more risk factors for HIV/AIDS than did women who were not abused.~The proposed intervention combines an empowerment model designed to help abused women make choices that protect the physical and emotional health of the woman and her family with a sexual safety model designed to help her make choices to reduce her risk of acquiring an STI or contracting HIV/AIDS. The integrated model adapts two interventions that have been tested with African American women on the US mainland and found to be effective as separate interventions for IPV and IPA and reducing the risk of STI/HIV. The adapted interventions will be used with abused African Caribbean women based on an a priori assessment of the cultural attitudes, beliefs and resources available to women living in an island environment with limited resources.
Inclusion criteria: inclusion criteria:

 Woman: African American/ African Caribbean/African heritage/Mixed

 Age 18 - 44 (A.1)

 Abused (physical, sexual emotional abuse) by an intimate male partner based on responses to screening questions

 Has had an intimate male partner in the last 2 years

 Resident of the US Virgin Islands and plans to remain for next two years

Exclusion criteria: :

 Woman: Not African American/African Caribbean or African Heritage/Mixed

 Under or over age limit

 No intimate partner in the last two years

 No history of physical, sexual or emotional abuse by an intimate partner

 Non resident of US Virgin Islands


Reducing Symptoms of Depression in Low-Income Mothers

Summary: This study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs.
Inclusion criteria: inclusion criteria:

 Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale

 Child who is 6 weeks to 30 months old

 Child who is enrolled in an Early Head Start program

Exclusion criteria: :

 Regular use of psychotropic medication

 Regular use of psychotherapy or drug/alcohol treatment

['Modified Interpersonal Therapy', 'Attention control/usual care']

Modified Interpersonal Therapy
Attention control/usual care


A Trial Using Double-Bolus THR-100 Versus Streptokinase

Summary: This novel fibrinolytic agent is a 136 amino acid single chain protein secreted by some strains of Staphylococcus aureus and readily produced by recombinant DNA technology. Two natural variants of recombinant staphylokinase, THR-100 and SakSTAR, have been developed for investigational use in preliminary trials. Like SK, it forms an equimolar complex with plasmin which in turn activates plasminogen to plasmin. Unlike SK, the complexed, activated molecule (which undergoes proteolytic cleavage of the first ten amino acids to generate active staphylokinase) has a high degree of fibrin-selectivity in a human plasma milieu. This fibrin-selectivity is due in large measure to potent activation at the clot surface by trace amounts of plasmin, and rapid inactivation of the circulating complex by antiplasmin. Hence, it provides an interesting and promising alternative therapy.
Inclusion criteria: inclusion criteria:

 Male or female patients aged 30 to < 75 years inclusive.

 Patients presenting within 12 hours with symptoms presumed secondary to an acute myocardial infarction lasting at least 20 minutes and accompanied by ECG evidence of > 1mm of ST elevation in 2 or more limb leads or > 2mm in 2 or more contiguous precordial leads or suspected new left bundle branch block will be eligible.

 Patients must be in the hospital or the emergency department and able to receive the study medication within 12 hours of onset of symptoms.

 Females of child-bearing age, not using a generally accepted method of contraception must have a negative urine pregnancy test.

 Written informed consent should be sought from the patient prior to inclusion in the study. If unable to do so, informed verbal consent will be obtained. If neither is possible, a legally acceptable representative (relative) should provide written consent.

 NB Verbal or written consent should be followed by written informed consent from the patient at the earliest subsequent opportunity.

Exclusion criteria: :

 Previous administration of staphylokinase.

 Active bleeding or known hemorrhagic diathesis.

 Any history of stroke, transient ischemic attack, dementia, or structural CNS damage e.g. neoplasm, aneurysm, AV malformation.

 Major surgery or trauma within the past 3 months.

 Significant hypertension i.e. SBP 180 mm Hg and/or DBP 110 mm Hg at any time from admission to randomization.

 Current treatment with vitamin K antagonists resulting with an INR > 1.5.

 Anticipated difficulty with vascular access.

 Prolonged (>10 min) cardiopulmonary resuscitation or cardiogenic shock.

 Patients who have participated in an investigational drug study within the past 30 days.

 Pregnancy or lactation, parturition within the previous 30 days.

 Any serious concomitant systemic or life limiting disorder that would be incompatible with the trial

 Patients known to have a history of or life limiting malignant disease or HIV.

 Significant hepatic or renal dysfunction or any other condition which, in the opinion of the Investigator, makes the patient unsuitable for study entry.

 Previous participation in this trial


Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury

Summary: The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cord injury
Inclusion criteria: inclusion criteria:

 either gender and 18-65 years old;

 acute or subacute traumatic spinal cord injury (defined as SCI resulting from an exteneral non-penetrating cause that occurred within 4 weeks);

 neurological status of ASIA A;

 neurological level between C5-T11;

 MRI shows injury site is within 3 vertebral level and necrotic focus, if exist, is less than 1/3 of the spinal cord diameter;

 professional judgment determinate that subjects need a spinal decompression surgery;

 subjects able to complete neurological examination;

 subjects have voluntarily signed and dated an informed consent form.

Exclusion criteria: :

 penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic conditions;

 spinal cord lesion exceeds three segments or necrotic focus with diameter larger than 1/3 of the spinal cord;

 severe complications;

 significant medical diseases or infection;

 pregnant or lactating woman, or female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study;

 unavailability of suitable umbilical cord blood cells;

 contraindication of lithium carbonate and/or spinal decompression surgery

 subject is currently participating in another study or has been taking any investigational drug within the last 4 weeks prior to screening;

 investigator suggests that the subject would not be suitable to participate this study

['Conventional Treatment', 'Lithium Carbonate Tablet', 'Cord Blood Cell', 'Placebo']

Conventional Treatment
Lithium Carbonate Tablet
Cord Blood Cell
Placebo


Osteoporosis and Fall Prevention Education

Summary: Objective: The study is to increasing osteoporosis awareness with fracture risk assessments and management as well as fall prevention among elderly in northern region of Taiwan.~Method: Six community osteoporosis and fall prevention educational programme will be held at northern region of Taiwan. A questionnaires design including demographic variables , FRAX variables, nutritional variables and osteoporosis and fall knowledge variables as well.The pretest-posttest method was used to analyse the effect on education.~Expected outcomes : (1)Fall prevention educational programme will hold in northern region of Taiwan at different communities in order to increasing osteoporosis awareness with fracture risk assessment tool, establishing fall knowledges among elderly and some fall prevention skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than 20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend for BMD measurement.
Inclusion criteria: inclusion criteria:

 Adults between the ages of 40 to 90.

 Adults who been fractures prior to assessment.

 Adults who have ability, well conscious to complete the questionnaires.

Exclusion criteria: :

 1.Adults who have treatment currently will not include in this study.


Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)

Summary: The investigators' primary research objective is:~To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive Care Unit (ICU) patients based on:~the proportion of patients with trough anti-Xa > 0.40 IU/mL during dalteparin prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin prophylaxis;~the risk of major bleeding during the treatment period.~The investigators' secondary research objectives are:~To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients with severe renal insufficiency;~To identify clinical and laboratory factors that predict an excessive anticoagulant effect (anti-Xa > 0.10 IU/mL);~To estimate the relationship between trough anti-Xa levels and bleeding.~The DIRECT Pilot Study:~Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address potential problems with protocol implementation.
Inclusion criteria: inclusion criteria:

 Adult patient aged > 18 years

 Admitted to an ICU with an expected ICU length of stay > 72 hours

 Severe renal insufficiency, defined by a calculated CrCl < 30 mL/min/1.73m2

Exclusion criteria: :

 ICU admission for > 2 weeks at time of screening

 ICU admission within 3 months of cardiac surgery or neurosurgery

 Active bleeding or at high risk for bleeding complications

 Thrombocytopenia (platelet count < 75 x 10^9/L) at time of screening

 Coagulopathy (International Normalized Ratio [INR] or activated partial thromboplastin time [aPTT] > 2 times upper limit of normal) at time of screening

 Patient had an indwelling epidural catheter for epidural analgesia within the last 12 hours

 Receipt of > 2 doses of LMWH (prophylactic- or therapeutic-dose) in the ICU

 Receiving or requiring therapeutic-dose anticoagulation (eg., deep vein thrombosis [DVT]) at time of screening

 Receiving dialysis that requires anticoagulation (eg., PRISMA, slow continuous ultrafiltration [SCUF]) at time of screening

 Weight < 45 kg

 Woman who is pregnant or lactating

 Bilateral lower limb amputation

 Previous adverse reaction to heparin or LMWH (eg., allergy, heparin-induced thrombocytopenia [HIT])

 Contraindication to receiving blood products

 Life expectancy < 14 days or receiving palliative care

 Prior enrolment in this study or enrolment in a concurrent related clinical trial

 Patient or surrogate decision-maker does not provide consent to participate in study


Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens

Summary: To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA® HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany.
Inclusion criteria: inclusion criteria:

 Women aged 30 - 60 years

 Women attending gynaecological practices for routine screening

 Women who gave informed consent to participation in the study

Exclusion criteria: :

 Women with hysterectomy or known destructive therapy to the cervix

 Women who are pregnant

 Women with an abnormal cytology result during the previous 6 months

 Women with known HIV infection or history of transplants

 Women vaccinated against HPV

 Women participating in another research protocol

['Thinprep® LBC', 'APTIMA® HPV Assay', 'HR HC2® HPV DNA', 'Colposcopy']

Thinprep® LBC
APTIMA® HPV Assay
HR HC2® HPV DNA
Colposcopy


Experience and Enhancement: Improving Colonoscopic Polyp Detection

Summary: The study looks at 2 hypotheses in 2 patient groups:~Are more experienced endoscopists better at detecting subtle lesions (polyps) on the lining of the colon (large bowel) than less experienced endoscopists?~Do existing and new techniques that can highlight lesions on the lining of the bowel improve endoscopists ability to spot them? This will be tested using video footage of endoscopies from 2 patient groups: those with a normal colon linig and those with colitis (bowel lining inflamation)
Inclusion criteria: inclusion criteria:

 Patients: over 18 years of age, with clinical indication for colonoscopy who are considered by the endoscopist to be fit for the procedure

 Endoscopists who have started colonoscopy training on a recognised training rotation. Consultants who perform colonoscopy regularly

Exclusion criteria: :

 patients under 18 years, patients with previous colorectal surgery or known familial polyposis, patients unable to give informed consent, pregnant patients, patients for whom coloscope insertion was difficult or uncomfortable, patients whose colon is not sufficiently cleared of stool, those unwilling to participate


Zonisamide for Weight Reduction in Obese Adults

Summary: The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.
Inclusion criteria: inclusion criteria: Age 18-65 years; BMI 30-50

Exclusion criteria: :

 Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks)

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MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA (CHOLCOEUR)

Summary: Patients with familial hypercholesterolemia (FH) at high cardiovascular risk may suffer from silent micro-infarctions (MI) before clinical coronary heart disease manifestations because of the lifetime exposure to elevated serum LDL-cholesterol levels.~The study aims to demonstrate the higher prevalence of silent myocardial infarction in a population of asymptomatic patients with familial hypercholesterolemia at high cardiovascular risk in comparison to control patients using Cardiac Magnetic Resonance sequences of delayed gadolinium enhancement.
Inclusion criteria: inclusion criteria:

 For patients with heterozygous form of familial hypercholesterolemia:

 Aged between 40 and 60 years

 With an identified genetic mutation (LDL-R, ApoB, PCSK9)

 Asymptomatic,

 With no EKG sign of ischemia

 No personal history of coronary heart disease.

 Treated or untreated by lipid lowering treatment

 High cardiovascular risk identified by 1 of the following criteria:

 1. Current smoking (1 cigarette a day) 2 Family history of very premature onset CHD: first- or second-degree male relative onset before age 45, first- or second-degree female relative onset before age 55 3.Two or more cardiovascular risk factors among this list: increasing age (men > 30, women > 40 years of age), LDL-C > 250 mg/dL, male sex, family history of premature onset CHD, first-degree male relative onset before age 55, first-degree female relative onset before age 65, metabolic syndrome, HDL-C < 40 mg/dL, hypertension (BP > 140/or > 90 mmHg or drug treatment), Lp (a) ≥ 50 mg/dL, tendon xanthoma

 For control subjects:

 Aged between 40 and 60 years

 With a normal lipid profile (LDL-C < 1.6g/L HDL-C > 0,45g/L and TG < 4g/L) and untreated by any lipid lowering therapies

 Asymptomatic,

 With EKG showing normal sinus rhythm , no sign of ischemia nor Left Bundle Branch Block

 No personal history of coronary heart disease.

 Control subjects will be matched for age/gender/smoking status and blood pressure

Exclusion criteria: :

 Non-affiliation to a healthcare system

 Consent refusal

 Contra-indication to MRI or to gadolinium injection.

 Claustrophobia, metallic devices, pacemaker, mechanical valve implanted before 1985, pregnancy, nursing

 Renal failure

 Technical contra-indication: patient diameter > 70 cm weight > 250 kg

 Personal history of cardiovascular disease and myocardial infarction

 Diabetes mellitus

 Uncontrolled hypertension

 TG < 4 g/L

 Previous use of an Amgen product in the past 12 months

['Familial Hypercholesterolemia - Heterozygous']


Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)

Summary: This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD). The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15 trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one PET study. The investigators will also carefully document trauma history, and collect behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11 (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.
Inclusion criteria: inclusion criteria for patients with PTSD:

 age 18-55 years old

 currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score > 50.

Exclusion criteria:  for patients with PTSD:

 any primary Axis I disorder other than PTSD (e.g. psychosis)

 medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders

 a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence

 current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)

 current breast feeding

 use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests

 acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study

 general MRI

['Positron emission tomography (PET) imaging']

['Post-traumatic Stress Disorder (PTSD)', 'Trauma']

Post-traumatic Stress Disorder (PTSD)
Trauma


Chloroquine Population Pharmacokinetics in Pre and Post-partum Women

Summary: For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body of evidence suggesting that pregnant women may require different doses of drugs, including antimalarials due to the physiological changes of pregnancy. It is important that any drug used in pregnant women it is given at the correct dose. The only way to evaluate this is by pharmacokinetic studies. The investigators propose to evaluate the pharmacokinetics of chloroquine when use to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same evaluation in the same woman post-partum is required as a control.
Inclusion criteria: inclusion criteria:

 Age 18-50 years

 Gestational age (ultrasound confirmed) > 13.0 weeks

 Viable fetus as assessed by ultrasound scanning

 Microscopically confirmed uncomplicated P.vivax malaria

 Willingness and ability to comply with the study protocol for the duration of the trial

 Written informed consent provided

 No signs of labour

Exclusion criteria: :

 Known hypersensitivity to chloroquine

 Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1

 Gastrointestinal dysfunction that could alter absorption or motility

 History or known liver diseases or other chronic diseases (excluding thalassaemia & G6PD deficiency)

 Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study

 Splenectomy

 Hematocrit (HCT) < 20% (based on field reading i.e. capillary sample)

 Taking contraindicated medications

 History of narcotic or alcohol abuse


A Study of the Association Between Tobacco Smoking and Bipolar Affective Disorder

Summary: The purpose of this study is to examine whether tobacco smoking is associated with bipolar affective disorder (severity of depressive and manic symptoms, presence of psychotic symptoms, history of a suicide attempts and other clinical features.)
Inclusion criteria: inclusion criteria:

 Age 18-65 male or female

 DSM -IV criteria for bipolar I affective disorder

 Ability and willingness to sign informed consent for participation in the study

Exclusion criteria: :

 Unwillingness or inability to participate in the study


The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy

Summary: This prospective randomized study aims to comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy.~A total of 83 patients will be randomized into one of three groups (group C or group I or group P) based on Excel number generation.~Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.~Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg lidocaine and normal saline 100cc.~Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8, 12, 24, 48 hours postoperatively.
Inclusion criteria: inclusion criteria:

 Laparoscopic cholecystectomy

Exclusion criteria: :

 mental change

 allergy to local anesthetics

['Intravenous lidocaine injection', 'Intraperitoneal lidocaine irrigation group', 'Intravenous normal saline injection']


Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso

Summary: This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso. Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and 9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart. Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later. Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA assessments pre-vaccination and 1 month post-vaccination.~The immunogenicity and reactogenicity of PCV13 in the standard schedule groups (e.g. 6, 10, 14 weeks for infants and single dose for toddlers) will be compared to that observed in the PCV13 licensure trials. Within each age group the alternative schedule will be compared to the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage (infants only).
Inclusion criteria: Infants inclusion criteria

 Child has birth weight ≥ 2500g

 Child was born at ≥ 37 weeks of pregnancy or judged to be full-term by midwife or birth attendant

 Mother has resided in Burkina Faso for at least 2 years

 Mother has African nationality

 Child will reside in Bobo-Dioulasso urban area for the duration of the study

 Parent or guardian has given informed consent for child's participation

 Infants
Exclusion criteria:

 Child was born with a congenital abnormality

 Child has chronic or acute severe illness requiring specialized medical care

 Child has a blood coagulation disorder

 Mother has known HIV infection

 Child is enrolled in another clinical trial

 Child has known allergy to a component of the vaccine

 Child received a pneumococcal vaccine outside the context of the trial

 Child is 53 days of age or older at 6 week visit

 Child weighs <3500g at the 6 week visit

 Blood draw at 6 week visit was unsuccessful after 3 attempts

 Toddlers inclusion criteria

 Child is 12 to 15 months of age

 Child has resided in Burkina Faso since birth

 Child has African nationality

 Child will reside in Bobo-Dioulasso urban area for the duration of the study

 Parent or guardian has given informed consent for child's participation

 Toddlers


Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks

Summary: OBJECTIVES:~Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and effective for the prevention of cyclic attacks of acute porphyria in women.
Inclusion criteria: PROTOCOL ENTRY CRITERIA:

 --Disease Characteristics-- Acute porphyria, i.e.: Acute intermittent porphyria Hereditary coproporphyria Variegate porphyria Definite cyclic attacks with severe abdominal pain and other porphyria symptoms during luteal phase of menstrual cycle only Attacks resolve completely within 5 days of onset of menses, i.e., no symptoms between attacks At least 4 to 6 attacks during the 6 months prior to entry More than half of these attacks must meet the following criteria: Readily distinguishable from menstrual cramps and premenstrual syndrome Required hospitalization for narcotic analgesics, phenothiazines, hematin, intravenous fluids, or other treatment Luteal attacks not requiring hospitalization must be similar in symptoms and differ only in severity No life-threatening porphyria attacks No cyclic abdominal pain unless caused by porphyria --Prior/Concurrent Therapy-- At least 6 months since ovulation suppression --Patient Characteristics-- Reproductive: Menstrual cycle 25-35 days for at least 6 months prior to entry Pelvic exam normal within 60 days prior to entry Pap smear normal, i.e., no dysplasia No amenorrhea No other menstrual abnormality No other gynecologic abnormality Negative pregnancy test Medically approved contraception required for 2 months prior to entry and throughout study OR at least 1 menstrual cycle following tubal ligation Other: No allergy to gonadotropin-releasing hormone analogues No clinically significant abnormal laboratory test results No medical contraindication to protocol treatment
Exclusion criteria:


Operative Treatment of Endometriosis Patients in Turku University Hospital

Summary: The women's clinic at Turku University Hospital has also since year 2000 accomplished and systematically increased advanced surgical treatment for the endometriosis patients with difficult disease. The aim is to centralize endometriosis treatment in the hospital district and by doing that be able to offer exact diagnosis, advanced surgical treatment and infertility treatment for every patient in the hospital area. The main purpose of this study is to find out how the operative treatment of endometriosis patients in Turku University Hospital is functioning and to see how the quality of life of these patients is before and after the surgery. Furthermore, the structure of the endometriosis patients' endometrium and the different markers of blood and urine are studied.
Inclusion criteria: inclusion criteria:

 Endometriosis

 Adnexal finding

 Laparoscopic sterilization

Exclusion criteria: :

 Pregnancy

 Acute infection

 Hemoperitoneum

 Suspicion of a malignancy


Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning

Summary: Numerous studies Have shown that limb ischemic preconditioning can protect vital organs (including the heart) from ischemia-reperfusion injury,which has a broad application prospect.But its mechanism is still unclear. Evidence showed that humoral mechanisms may play an important role. This study was carried out on the limb ischemic preconditioning in healthy volunteers, collected their serum at different time points before and after treatment,classified and identified the serum proteins during different periods of limb ischemic preconditioning,by using methods including high abundant protein removal,Two-dimensional electrophoresis chromatography and mass spectrometry,then analysed activation and synthesis of the proteins in order to search for the proteins or peptides whose synthesis was activated by ischemic preconditioning. This study will be the first systemic explore of the changes in serum proteins of limb ischemic preconditioning in human body,and lay theoretical basis for the clinical application of limb ischemic preconditioning and for further explore of its humoral mechanism,thus provide clues for searching for protein or peptide having protective effects for organs.
Inclusion criteria: inclusion criteria:

 healthy volunteers aging 20-30 years old

 no cardiac，hepatic or renal，peripheral vascular diseases

 be willing to enter our study and sign an written informed consent

Exclusion criteria: :

 younger than 20 years old or older than 30 years old

 having cardiac，hepatic or renal，peripheral vascular diseases

 refuse to enter our study or sign an written informed consent


MelaFind Evaluations for Patients With Multiple Nevi

Summary: We have added objectives 4-6 to our updated study:~Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify signature lesions for a given patient.~Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify signature lesions.~Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity.~Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics.~Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion.~Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.
Inclusion criteria: Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion criteria:

 inclusion criteria:

 The lesion is pigmented (i.e., melanin, keratin, blood)

 The diameter of the pigmented area is not < 2 mm, and not > 22 mm

 The lesion is accessible to the MelaFind

 The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form;

 Cutaneous lesions that meet any of the following
Exclusion criteria:  will not be accepted:

['Clinically Atypical Pigmented Skin Lesion']


A Trial of Fimasartan for Early Diastolic Heart Failure

Summary: Approximately half of hypertensive patients have diastolic dysfunction and diastolic dysfunction is associated with development of congestive heart failure and increased mortality. Although diastolic heart failure associated with hypertension is a clinically significant problem, few clinical trials have been conducted and there is no proven pharmacological therapy to improve outcomes. To the best of the investigators knowledge, there has been no randomized trial to demonstrate that an antihypertensive drug improves diastolic function in hypertensive patients with diastolic dysfunction. The investigators hypothesize that fimasartan added to standard therapy will be superior to placebo in improving diastolic dysfunction in mildly symptomatic patients with hypertension and diastolic dysfunction, and try to examine this hypothesis in a double-blind, randomized comparison study using echocardiography.
Inclusion criteria: inclusion criteria:

 Untreated hypertension: systolic BP ≥ 140 or diastolic BP ≥ 90 mmHg or Treated hypertension

 Current heart failure symptoms with NYHA class II

 Evidence of diastolic dysfunction showing any 2 of the following:

 E/E' > 10, LV posterior wall thickness > 11 mm, BNP level > 40 pg/mL

Exclusion criteria: :

 Planned cardiac surgery or planned major non-cardiac surgery within the study period

 Stroke or coronary revascularization in the past 6 months

 LV ejection fraction < 50%

 Hypertrophic or restrictive cardiomyopathy, moderate or severe valve disease, constrictive pericarditis

 Atrial fibrillation with a heart rate > 120/min

 Sitting systolic BP < 100 mmHg

 Sitting systolic BP > 160 mmHg or diastolic BP > 95 mmHg despite antihypertensive therapy

 Significant renal disease manifested by serum creatinine > 2.5 mg/dL

 Clinically significant pulmonary disease, coronary artery disease

 A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer

 Female of child-bearing potential who do not use adequate contraception and women who are pregnant or breast-feeding


Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis

Summary: Clostridium difficile has become one of the leading causes of hospital acquired infections, and is associated with increased mortality. Patients with C. difficile associated disease (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result of earlier antibiotic usage. The current standard of care treatment for severe C. difficile, which consists of antibiotics, does not restore the microbiota. Restoration of the normal colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic microbial population to a more 'normal'state and lead to cure.~A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic megacolon. The management in this context is based on limited data, and for some the only available option is sub-total colectomy.~Although FMT is by no means a new therapeutic modality, there is limited information on its use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and mortality associated with treatment of patients with severe CDAD, and because the evidence supporting the current recommendations is weak and based upon the demonstration that FMT is an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.~Patients with severe CDAD can be divided into two operational groups; those that have diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through colonoscopy for all patients because current data suggest that the overall success rate of FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality), intra-colonic FMT administration is the preferred alternative.
Inclusion criteria: inclusion criteria:

 Both genders are eligible for study

 Age 18 years and older

 Able to provide written, informed consent

 Confirmed diagnosis of severe CDAD as defined above

Exclusion criteria: :

 (If any of the following apply, the subject MUST NOT enter the study):

 Pregnant or lactating women

 Need for prolonged antibiotics for other cause

 Other known etiology for diarrhea, or clinical infection with other known enteric pathogens

 Active, chronic conditions such as: Inflammatory bowel disease, Crohn's disease, Short bowel syndrome, Ulcerative or ischemic colitis

 Laxatives or motility-altering drugs within 12 hours of enrolment

 Clinically unstable. Hemodynamic instability defined as hypotension (mean arterial pressure < 60) not responsive to fluids.

 Any condition that, in the opinion of the investigator, would preclude safe participation in the trial or compromise the quality of the data obtained.

 Immune suppression, HIV, hematological or solid malignancy (chemotherapy in the past 3 months).

 Prior colon surgery


Renal Fractional Flow Reserve in Renal Artery Stenting

Summary: The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.
Inclusion criteria: inclusion criteria:

 At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography

 Hypertension defined according to WHO criteria

 Age 18-75 years

 Signed informed consent obtained

Exclusion criteria: :

 Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney

 Contraindications to percutaneous renal angioplasty with stenting

 Atrophy of the kidney supplied with stenosed artery

 Other well known secondary reason for hypertension

 Chronic heart failure NYHA II-IV

 Significant valvular heart disease qualified for surgery

 Persistent atrial fibrillation

 Renal failure with GFR below 30ml/min

['Renal Artery Stenosis', 'Hypertension']


Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection

Summary: Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).
Inclusion criteria: inclusion criteria:

 Males or nonpregnant, non-nursing females > 2 years old.

 Tuberculin (PPD) skin test reactors at high risk for developing TB but without evidence of active TB. High-risk reactors are defined as:

 Household and other close contacts of persons with culture-confirmed TB who are TST-positive as part of a contact investigation conducted within two years of the date of enrollment. Close contact is defined as > 4 hours in a shared airspace during a one-week period. Among close contacts, a positive TST is defined as > 5 mm induration after 5 TU of PPD placed intradermally using the Mantoux technique.

 TST converters--converting from a documented negative to positive TST within a two-year period. This is defined as persons with a tuberculin skin test of > 10 mm within two years of a nonreactive test or persons with an increase of > 10 mm within a two-year period.

 HIV-seropositive, TST positive (> 5 mm induration) persons.

 Persons with > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray, no prior history of TB treatment, > 5 mm induration on TST, and 3 sputum cultures negative for M. tuberculosis on final report.

 HIV-seropositive close contacts of persons with culture-confirmed TB, regardless of TST status. In addition, HIV-seropositive close contacts of persons with culture-confirmed TB who have a documented history of completing an adequate course of treatment for active TB or latent TB infection, are also eligible.

 Willing to provide signed informed consent, or parental consent and participant assent.

Exclusion criteria: :

 Current confirmed culture-positive or clinical TB

 Suspected TB (as defined by the site investigator)

 Tuberculosis resistant to isoniazid or rifampin in the source case

 A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years.

 A documented history of a completing an adequate course of treatment for active TB or latent TB infection in a person who is HIV-seronegative.

 History of sensitivity/intolerance to isoniazid or rifamycins

 Serum aminotransferase aspartate (AST, SGOT) > 5x upper limit of normal among persons in whom AST is determined

 Pregnant or nursing females

 Persons currently receiving or planning to receive HIV-1 protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 90 days after enrollment.

 Weight < 10.0 kg

['RPT + INH once weekly for 3 months given by DOT', 'Isoniazid (INH) daily for 9 months']


Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

Summary: Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand.~Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.
Inclusion criteria: inclusion criteria:

 adult patients (> 14 years) with suspected severe leptospirosis

 patients who presented with acute fever (oral temperature more than 38.00 C for <15 days) in the absence of an obvious focus of infection

 In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).

Exclusion criteria: :

 pregnant or breastfeeding

 those with history of bleeding disorder

 those who had underlying diseases such as chronic liver disease, diabetes mellitus

 those who received diuretic or glucocorticoid


Thyroid Hormones Treatment in Asthma Exacerbation

Summary: This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes.~The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation.~The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.
Inclusion criteria: inclusion criteria:

 18 years of age or older

 Known Asthma

 The exacerbation is defined as moderate or severe.

 Not currently enrolled as an active participant in another clinical trial of a medical therapy or device.

 The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy

Exclusion criteria: :

 60 years of age or older

 Known thyroid disorders

 Subject where thyrotoxicosis is suspected

 Known heart disease

 Heart rate > 140


Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy

Summary: The purpose of this study is to determine if VM202 is safe and effective in treating painful diabetic neuropathy.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years to ≤ 75 years

 Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of ≤ 10.0% at Screening) and currently on oral medication and/or insulin

 Diagnosis of painful diabetic peripheral neuropathy in both lower extremities

 Lower extremity pain for at least 6 months

 Visual analog scale (VAS) score of ≥ 40 mm at Initial Screening (0 mm = no pain - 100 mm very severe pain)

 Symptoms from the Brief Pain Neuropathy Screening (BPNS) is ≤ 5 point difference between legs at Initial Screening

 The average daily pain intensity score of the Daily Pain and Sleep Interference Diary completed after medication wash-out is ≥ 4 with a standard deviation ≤ 2

 The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is ≥ 3 at Screening

 Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes

 If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study

Exclusion criteria: :

 Peripheral neuropathy caused by condition other than diabetes

 Other pain more severe than neuropathic pain

 Progressive or degenerative neurological disorder

 Myopathy

 Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease)

 Active infection

 Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis)

 Positive HIV or HTLV at Screening

 Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at Screening

 Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy

 Stroke or myocardial infarction within last 3 months

 Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination

 Specific laboratory values at Screening including: Hemoglobin < 8.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, Creatinine > 2.0 mg/dL; AST and/or ALT > 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary

 Uncontrolled hypertension as defined as sustained systolic blood pressure (SBP) > 200 mmHg or diastolic BP (DBP) > 110 mmHg at Screening

 Patients with a recent history (< 5 years) of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings

 Subjects requiring > 81 mg daily of acetylsalicylic acid; If ≥ 81 mg are taken at screening, subjects may be enrolled if willing/able to switch to another medication

 Use of any opioids; subjects may be enrolled if willing and able to discontinue use of these drugs 14 days prior to starting the 7 Day Daily Pain and Sleep Interference Diary and refrain from taking these drugs for the duration of the study

 Subjects requiring regular COX-2 inhibitor drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (excepting inhaled steroids).Subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs for the duration of the study;

 Major psychiatric disorder in within last 6 months

 Body mass index (BMI) > 45 kg/m2 at Screening

 Any lower extremity amputation

 Use of an investigational drug or treatment in past 6 months

 Unable or unwilling to give informed consent

['Low Dose: 16 mg VM202', 'High Dose: 32 mg VM202', 'Control- Placebo (normal saline)']

Low Dose: 16 mg VM202
High Dose: 32 mg VM202
Control- Placebo (normal saline)


Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Summary: RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.~PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.
Inclusion criteria: inclusion criteria:

 DISEASE CHARACTERISTICS:

 Histologically confirmed non-small cell lung cancer

 Stage I or II disease (T1-3, N0, M0)

 T2 or T3 tumor ≤ 5 cm

 No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)

 Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed medically inoperable

 Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status

 PATIENT CHARACTERISTICS:

 Eastern Cooperative Oncology Group (ECOG) performance status 0-2

 Not pregnant or nursing

 Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment

Exclusion criteria: :

 No history of contrast allergy

 No psychological issues that would preclude the completion of study treatment

 PRIOR CONCURRENT THERAPY:

 No prior radiotherapy or chemotherapy

 No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)

 No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)

['computed tomography', 'fludeoxyglucose F 18', 'hypofractionated radiation therapy', 'stereotactic radiosurgery']

computed tomography
fludeoxyglucose F 18
hypofractionated radiation therapy
stereotactic radiosurgery


Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

Summary: The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.
Inclusion criteria: inclusion criteria:

 Hypertensive patients who have never taken Micombi Tablets.

Exclusion criteria: :

 None

['Telmisartan 80mg', 'Telmisartan 40mg', 'Hydrochlorothiazide 12.5mg']

Telmisartan 80mg
Telmisartan 40mg
Hydrochlorothiazide 12.5mg


Flu Vaccine Against Childhood Pneumonia, Bangladesh

Summary: Pneumonia is the leading cause of child death worldwide. Data from Bangladesh indicates that influenza has a substantial association with pneumonia among children less than two years old. This study will use commercially available trivalent inactivated vaccine (killed vaccine) to see if it can prevent early childhood pneumonia among children less than two years old. The study will vaccinate children across three seasons (3 years), and look at the effect on the attack rate of pneumonia, as well as its effects on laboratory-confirmed influenza. It will also look at the effect on laboratory-confirmed influenza illness among the non-vaccinated household contacts of all ages of these children.
Inclusion criteria: inclusion criteria:

 Children will be included if they are de jure residents 6 months to 23 months old at the time of first dose vaccination residing in households under surveillance.

Exclusion criteria: :

 Children will be excluded if they have known chronic respiratory, cardiac, or neurological (including seizure disorders) illnesses, are severely malnourished or require hospitalisation for any other reason, are suspected of having tuberculosis (WHO guidelines) [83], are known to have egg allergy, or parents withhold consent.

['Trivalent inactivated influenza vaccine']

['Pneumonia', 'Laboratory Confirmed Influenza']

Pneumonia
Laboratory Confirmed Influenza


Effectiveness of Spirometry as a Motivational Tool to Quit Smoking

Summary: The aim of the study is to asses the efficacy of the spirometry and a minimal smoking cessation counselling intervention to quit smoking after a year in patients older than 40 years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease (COPD) diagnosis.
Inclusion criteria: inclusion criteria:

 - Active smokers over 40 years and more than 10 pack-years

Exclusion criteria: :

 Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern.

 Patients with limitations in performing spirometry

 Age greater than 80 years

 Institutionalized patients

 Patients with a life expectancy less than 1 year

 Spirometry in the past 2 years

['Spirometry and a brief advice to quit smoking', 'Brief advice to quit smoking']


Iron Treatment for Young Children With Non-anemic Iron Deficiency

Summary: The pre-school years are critical years for children to acquire early learning skills such as language, fine motor and social skills; this is termed early child development. Primary care doctors (family doctors and pediatricians) are in a unique position to identify children with health or developmental problems. Screening is the process of testing healthy people for the earliest signs of health problems, followed by treatment, with the expectation that screening will improve the health of those screened. The focus of this research is screening young children for the earliest signs of iron deficiency (low blood iron levels) followed by treatment with oral iron.~Previous research has shown that children with later stages of iron deficiency have serious delays in their development. Some research has shown that these delays may persist into young adulthood often with a significant reduction in intelligence. Early stages of iron deficiency may be difficult for parents or doctors to detect, and a blood test is usually needed. However, Canadian guidelines do not recommend screening all children for iron deficiency, because there is not enough good quality research to prove that screening is effective.~In this study, the investigators will ask parents to allow their child between the ages of 1 to 3 years to have a blood test for iron levels. If the blood level is low, the child will be randomly assigned to receive either oral iron liquid for 4 months plus diet counseling, or a placebo liquid plus diet counseling. A psychologist will measure each child's early learning ability before and after the treatment. If this approach to screening children's blood iron levels followed by treatment improves children's development, parents and doctors may consider that routine blood screening tests are justified. Overall, this research is an important step to improving the ways in which primary care doctors can ensure that children have the best start to life-long health and achievement.
Inclusion criteria: inclusion criteria:

 Age between 18 and 36 months attending any well child visit

 Informed parental consent

Exclusion criteria: :

 Previously diagnosed: developmental disorder, genetic, chromosomal or syndromic condition, chronic medical condition, (with the exception of asthma and allergies), including chronic anemia, iron deficiency or recent oral iron supplementation or treatment

 Prematurity with a gestational age less than 35 weeks; low birth weight less than 2500 grams

 Attending the office for an acute illness, such as a viral illness, or other health concern other than well-child assessment

 Any contraindications to receiving elemental iron (i.e. NHP [natural health product], comparator or placebo)

 The use of any Natural Health Product containing the same medicinal ingredient(s) as the investigational product

 English not spoken to the child in the home or in a child care setting

['Ferrous Sulfate', 'Placebo', 'Dietary counseling']

Ferrous Sulfate
Placebo
Dietary counseling


Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

Summary: Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas are mostly based on observational studies. Here we present data from a prospective randomized pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or placebo for 30 days.~Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed CSDH were recruited from a single center and randomized in order to receive dexamethasone or placebo as a conservative treatment. Patients affected to the treatment group received oral dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed for 6 months and the rate of success of conservative treatment versus placebo was measured. Parameters such as hematoma thickness and global impression of change were also compared before and after treatment with chi-square tests. Adverse events and complications were documented.
Inclusion criteria: inclusion criteria:

 18 years and older

 evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tomography) scan or MRI (magnetic resonance imaging)

 classified between 0 and 2 using the Markwalder grading scale

Exclusion criteria: :

 contraindications or intolerance to corticosteroid therapy

 patients already undergoing steroid treatment for any other indication

 previous neurological surgery up to one year prior to being considered for the study

 concomitant cerebral pathology of neoplastic or presumed infectious origin

 anticoagulant therapy that could not be stopped for 6 months

 refusal to participate in the study


A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

Summary: The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.
Inclusion criteria: inclusion criteria:

 Japanese healthy elderly male and female ≥65 years old.

 Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg.

 Be able to understand and comply with the requirements of the study as judged by the investigator(s).

Exclusion criteria: :

 History of any clinically significant medical or neurologic disease or disorder.

 History of gastrointestinal surgery or unintentional rapid weight loss.

 Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.


Zinc and Copper Absorption in Neonates With Bilious Losses

Summary: We propose to examine the absorption and excretion of zinc and copper in infants with ostomies. This will be accomplished by measuring baseline excretion and serum levels of zinc, copper, and ceruloplasmin, and by utilizing stable isotopes of zinc and copper to measure absorption and excretion.~To determine how the presence of an ileostomy impacts zinc and copper metabolism in infants at three time points: 1) when the infant has an ostomy and is receiving the majority of calories from total parenteral nutrition (TPN); 2) when the infant has an ostomy and is receiving primarily enteral nutrition without TPN; and 3) when/if the infant has a surgery to reconnect the bowel and is receiving primarily enteral nutrition.~For the first part of the study, excretion data for zinc will be obtained for ostomy patients. We hypothesize that infants with an ostomy will excrete more zinc in their stools than healthy term or preterm infants without ostomies.~For the second part of the study, we will obtain data on zinc absorption, secretion, and excretion through use of stable isotopes. Jalla et al determined that healthy infants retain zinc of 0.4 mg/day. We hypothesize that due to increased zinc losses, the infants in the study will be less positive than the healthy infants in the study by Jalla et al. Our study is designed to be able to detect if the ostomy patients net retention is one-half that described by Jalla (i.e. 0.2 mg/d). We will also obtain data on copper absorption, secretion, and excretion through the use of stable isotopes in the second part of the study. As a pilot study, we do not fully know what to expect regarding copper levels in infants with ostomies, but we hypothesize that they may be less positive than healthy infants without ostomies. Also, we hypothesize that zinc and copper are competitively absorbed in the gut; therefore, infants who receive more zinc may absorb less copper.~For the third part of the study, we will obtain data on zinc absorption through the use of stable isotopes after the infant has had surgery to reanastomose the bowel. We hypothesize that there may be continued zinc losses above those documented for healthy infants who have never had an ostomy, but decreased losses compared to when the infant had an ostomy.
Inclusion criteria: inclusion criteria:

 Presence of ileostomy due to any disease or condition (i.e., necrotizing enterocolitis, intestinal atresias, gastroschisis, or intestinal perforations)

 Minimum birth weight of 500g

 Likely to survive

Exclusion criteria: :

 Dysmotility of the gastrointestinal system

 Major congenital anomalies, including heart disease

 Meconium ileus

 Not expected to survive for at least 2 weeks


The Effects of Blood Pressure Reduction on Cerebral Perfusion and Cognition in the Elderly Population

Summary: The purpose of this study is to determine if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed before and after treatment.
Inclusion criteria: inclusion criteria:

 Age >= 70 years

 Systolic office blood pressure >= 160 mmHg

 Systolic home blood pressure >= 155 mmHg

Exclusion criteria: :

 Diabetes Mellitus

 Atrial fibrillation

 Dementia

 Renal failure requiring dialysis

 Life expectancy of less than 1 year

 Disabling stroke

 Contraindication for MRI or anti-hypertensive medication

 Systolic blood pressure > 220 mmHg


Ultrasonography Assessment of Septic Arthritis on Native Joint

Summary: The aim of this trial is to study the interest of ultrasonography among patients with septic arthritis.~Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.~Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.~Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.~However, MRI is expensive and not rapidly accessible.~Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.~The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis.~The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.
Inclusion criteria: inclusion criteria:

 Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes, of La Roche sur Yon and of Saint-Nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative.

Exclusion criteria: :

 Presence of material on the targeted joint

 Age < 18 years old

 Patients under guardianship

 Pregnancy


Ginger.io Behavioral Health Study

Summary: This Study will evaluate the impact of a smartphone-based platform on a range of outcomes for medically-underserved patients with mood disorders (e.g. depression, anxiety, bipolar) cared for in a large statewide community health center. The primary goal of the Study is to reduce emergency room (ER) visits, hospitalizations, and to look at changes in service utilization by using the Ginger.io platform to enhance communication between behavioral health providers and their patients, increasing the early detection of exacerbations in mood disorders (e.g. depression, anxiety, bipolar) and proactive outreach. The secondary goal is to improve clinical & behavioral health outcomes.
Inclusion criteria: inclusion criteria:

 Age 18 or older

 Experiencing mood disorders (e.g. depression, anxiety, bipolar) defined as a visit with a specified DSM-V code (295.7 Schizoaffective Disorder (Depressive type), 295.7 Schizoaffective Disorder (Bipolar type), 296.41 Bipolar I Current or most recent episode manic Mild, 296.42 Bipolar I Current or most recent episode manic mod, 296.43 Bipolar I Current or most recent episode manic sev, 296.44 Bipolar I Current or most recent episode manic w psychotic, 296.45 Bipolar I Current or most recent episode manic in partial remission, 296.46 Bipolar I Current or most recent episode manic in full remission, 296.40 Bipolar I Current or most recent episode unspecified, 296.40 Bipolar I Current or most recent episode hypomanic, 296.45 Bipolar I Current or most recent episode hypomanic in partial remission, 296.46 Bipolar I Current or most recent episode hypomanic in full remission, 296.40 Bipolar I Current or most recent episode hypomanic unspecified, 296.51Bipolar 1 Current or most recent episode depressed mild, 296.52 Bipolar 1 Current or most recent episode depressed mod, 296.53 Bipolar 1 Current or most recent episode depressed sev, 296.54 Bipolar 1 Current or most recent episode depressed w psychotic, 296.55 Bipolar 1 Current or most recent episode depressed in partial remission, 296.56 Bipolar 1 Current or most recent episode depressed in full remission, 296.50 Bipolar 1 Current or most recent episode depressed unspecified, 296.7 Bipolar 1 current or most recent episode unspecified, 296.89 Bipolar II, 301.13 Cyclothymic, 296.83 Bipolar due to Medical Condition, 296.89 Other Specified Bipolar, 296.80 Unspecified Bipolar, 296.99 Disruptive Mood Dysregulation disorder, 296.21 Major Depressive Disorder Single Episode Mild, 296.22 Major Depressive Disorder Single Episode mod, 296.23 Major Depressive Disorder Single Episode sev, 296.24 Major Depressive Disorder Single Episode w psychotic, 296.25 Major Depressive Disorder Single Episode in partial remission, 296.26 Major Depressive Disorder Single Episode in full remission, 296.20 Major Depressive Disorder Single Episode unspecified, 296.31 Major Depressive Disorder Recurrent Episode mild, 296.32 Major Depressive Disorder Recurrent Episode moderate, 296.33 Major Depressive Disorder Recurrent Episode severe, 296.34 Major Depressive Disorder Recurrent Episode w psychotic, 296.35 Major Depressive Disorder Recurrent Episode in partial remission, 296.36 Major Depressive Disorder Recurrent Episode in full remission, 296.30 unspecified, 300.4 Persistent Depressive Disorder (Dysthymia), 625.4 Premenstrual Dysphoric Disorder, 293.83 Depressive Disorder due to another medical condition, 311 Other specified depressive disorder, 311 Unspecified Depressive disorder, 309.21 Separation anxiety disorder, 300.29 Specific Phobia, 300.23 Social anxiety do, 300.01 Panic Disorder, 300.22 Agoraphobia, 300.02 GAD, 293.84 Anxiety do due to another med condition, 300.09 other specified anxiety do, 300.00 Uspecified Anxiety do, 309.0 Adjustment do with depressed mood, 309.24 Adjustment do with anxiety, 309.28 Adjustment do with mixed, 309.4 Adjustment do with w disturbance of emotions and conduct, 309.9 Adjustment do unspecified, 300.7 Illness anxiety disorder, 293.83 Mood do NOS, 296.9 Mood do unspecified, 291.89 alcohol inducted mood do, 292.84 amphetamine inducted mood do 292.84 cocaine inducted mood do, unspecified inducted mood do, 296.66 episodic mood dis unspecified, 296.64 Severe mixed bipolar do)

 Possessing a smartphone with either an Android or iOS platform

 Able to read and write in English

 Have a designated primary behavioral health care provider who is either using the app with their patients (intervention) or is issuing the surveys on paper in their clinic (control)

Exclusion criteria: :

 None

['Anxiety', 'Depression', 'Bipolar I Disorder', 'Bipolar II Disorder']

Anxiety
Depression
Bipolar I Disorder
Bipolar II Disorder


The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease

Summary: The purpose of this study is to investigate the effects of performing a breathing muscle warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD). The main aim is to see whether performing a breathing muscle warm up can improve distance walked in a 6 minute walk test and also decrease perceptions of effort and breathlessness.
Inclusion criteria: inclusion criteria:

 A clinical diagnosis of COPD

 Aged between 35 and 90 years

 Able to fluently read and speak English

 Willing and able to sign informed consent

 Be able to comply with the procedures outlined for the study

Exclusion criteria: :

 Cardiac disease (including arrhythmias)

 A medicinal requirement for rate limiting calcium antagonists or beta blockers

 Cerebrovascular disease

 Peripheral vascular disease

 Requirement for supplemental oxygen therapy

 CO2 (carbon dioxide) retention

 Malignancy

 Orthopaedic or neurological conditions effecting the ability to exercise

 Clinically apparent heart failure

 Renal, hepatic or inflammatory disease

 Instability of COPD

 Any other reason leading to the inability to complete the requirements of the study.

 Additionally: If participants have a resting HR above 120beats.min-1, systolic blood pressure above 180mm Hg or diastolic blood pressure above 100mm Hg prior to the 6 minute walk test they will not be able to commence the test.

['Inspiratory Warm Up', 'Expiratory Warm Up', 'Combination Warm Up', 'Control Trial']

Inspiratory Warm Up
Expiratory Warm Up
Combination Warm Up
Control Trial

['Chronic Obstructive Pulmonary Disease']


Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy

Summary: Epilepsy is a frequent neurological disorder with about a third of patients having seizures despite treatment. At least some of these seizures can be linked to a low compliance and therapy adherence of patients. Compliance is defined as the extent to which a person's behavior (in terms of taking medication, following diets, or executing life style changes) coincides with medical or health advice. Therapy adherence of patients suffering from epilepsy is low with reported rates between 30 and 50%, although adherence to anticonvulsive drug therapy is critical for effective disease management and low therapy adherence is associated to higher mortality in epilepsy. The reasons for low therapy adherence are still a matter of research. Some known factors influencing compliance in epilepsy are related to its chronic nature, but others seem to lie in a complex interaction between psychiatric comorbidity and an impairment of neural systems underlying behavior. Furthermore, therapy adherence rests a variable difficult to measure, especially in epileptic patients where classical tools such as questionnaires and electronic monitoring devices have been shown to be imprecise. It has been argued that the term 'compliance' should be replaced by 'co-operative behavior' and non-compliance can therefore be interpreted as troubled co-operative behavior. This behavioral approach offers the potential of using tools and methods of the latest developments in behavioral neuroscience. Neuroeconomics, a scientific field on the border of psychology, economics and neuroscience, has used economic game paradigms in order to operationalize cooperative behavior and to identify several brain areas by functional brain imaging that have been linked to social co-operative behavior. The majority of these brain areas are located in the frontal cortex [ventromedial frontal/orbitofrontal cortex, and rostral anterior cingulate cortex. Epilepsies originating in the frontal lobe are subsumed under the term frontal lobe epilepsy (FLE) and represent 20-30% of all partial seizures and 25% of all refractory focal epilepsies referred to epilepsy surgery.~The investigator's project plans to study compliance and cooperative behavior of patients suffering from frontal lobe epilepsies through a neuroeconomic approach by (1) comparing the behavior of these patients in the prisoners' dilemma game to the behavior of age-, gender-, and education-matched healthy controls, (2) correlation of game behavior to brain activation measured by functional magnetic resonance imaging in both patients and healthy controls and (3) studying the link between cooperative behavior to compliance captured by pill counts and questionnaires.
Inclusion criteria: inclusion criteria (Patients):

 Age between 18 and 50

 Diagnosis of frontal lobe epilepsy

 Written consent to participate

 Right-handed

 Hospital Anxiety and Depression Scale Score under 10

 Obsessive Compulsive Inventory Score under 40

 Sufficient language skills

 Social insurance

 inclusion criteria (controls):

 Age between 18 and 50

 Written consent to participate

 Right-handed

 Hospital Anxiety and Depression Scale Score under 10

 Obsessive Compulsive Inventory Score under 40

 Sufficient language skills

 Social insurance

Exclusion criteria:  (Patients):

 Seizures types other than epileptic (psychogenic etc.)

 Mental retardation

 Epilepsies other than FLE

 Other known neurological diseases

 Hospital Anxiety and Depression Scale Score over 10

 Obsessive Compulsive Inventory Score over 40

 Pregnancy

 non-MRI suitable transplants (cardiac pacemaker etc.), claustrophobia, orthopedic diseases that prevent lying in the scanner

 During exclusion period of other studies

 No social insurance

['functional magnetic resonance imaging exam']


A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer

Summary: The primary objective of this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound.~Secondary objectives are~determination of the pharmacokinetic (PK) profile;~exploratory pharmacodynamic analysis; and~collection of preliminary data on anti-tumour efficacy.
Inclusion criteria: inclusion criteria:

 inclusion criteria

 Patients with a confirmed diagnosis of advanced, measurable or evaluable, nonresectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months as demonstrated by serial imaging

 Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options

 Tumour tissue must be available for the determination of E-cadherin expression (archived tissue or fresh biopsy).

 Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (CTCAE grade < 2)

 Age = 18 years

 Life expectancy = 3 months

 Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation, including consent for PK samples, for using an archived tumour sample for determination of Ecadherin status, for reviewing previous tumour scans (and for providing skin biopsies, in patients in dose finding phase enrolled before protocol amendment 03)

 Eastern Cooperative Oncology Group (ECOG), R01-0787) performance score 0-1

 Additional inclusion criteria in the expansion phase:

 Patients must have measurable progressive disease within the last 6 months, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1, R09-0262)

 deleted

 Patients must be willing to provide paired tumour biopsies for PD determination. Refer to section 5.6.3

 Patients should fit into one of the categories described below:

 I. Metastatic adenocarcinoma of the pancreas Patients should have preferably received at least one line of systemic treatment for metastatic disease and preferably not more than 2 prior regimens for metastatic disease.

 II. Platinum-resistant ovarian carcinoma, defined as recurrence within 6 months after completion of prior platinum-based chemotherapy Patients should have received preferably no more than 5 previous lines of systemic treatment for metastatic disease.

 III. Oesophageal carcinoma Patients with oesophageal carcinoma of adenocarcinoma- or squamous cell histology who have received preferably not more than 2 previous lines of systemic treatment for metastatic disease.

 IV. Soft tissue sarcoma Patients should preferably have received no more than 2 previous lines of systemic treatment for metastatic disease.

Exclusion criteria: :

 Serious concomitant non-oncological disease/illness

 Active/symptomatic brain metastases

 Second malignancy

 Pregnancy or breastfeeding

 Women or men who are sexually active and unwilling to use a medically acceptable method of contraception.

 Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication


Interferon-lambda: Novel Biologics for Controlling Neutrophil-mediated Pathology in Rheumatic Diseases?

Summary: Neutrophils emerge as key immune cells in the initiation and perpetuation of immune responses in autoimmune diseases. They display marked abnormalities in phenotype and function in various autoimmune diseases, including systemic vasculitis, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).~These neutrophils are characterised by an extended life span, increased capacity to produce reactive oxygen species, active gene expression and release of extracellular traps. Consequently, there is a need for better understanding of neutrophil phenotype and functions in these conditions, as well as for identifying molecules capable of specifically manipulating neutrophil function. The investigators have recently discovered that interferon lambdas (IFN-λs), also known as interleukin 28 (IL28) and interleukin 29 (IL29), class II cytokines with previously studied anti-viral biological functions, specifically suppress neutrophil infiltration and interleukin-1β production and thereby, halt and reverse the development of collagen induced arthritis (CIA). The investigators propose to further investigate the cellular and molecular mechanisms behind this suppression and examine the translational potential of the investigators' finding by examining the IFN-λ receptor expression and function in neutrophils isolated from the blood of healthy donors and rheumatic patients (early rheumatoid arthritis and vasculitis).
Inclusion criteria: inclusion criteria:

 Healthy volunteer or

 Recent diagnosis of rheumatoid arthritis within 1 month or

 New diagnosis of giant cell arteritis within 1 month or

 New diagnosis of anti-neutrophil cytoplasm antibody associated vasculitis within 1 month or

 Flare of anti-neutrophil cytoplasm antibody associated vasculitis within one month

Exclusion criteria: :

 Unable to provide written informed consent


Proportion of Hysterectomy After Female Sterilization

Summary: The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had undergone sterilization through tubal ligation.
Inclusion criteria: inclusion criteria:

 Age: 18 to 49 years at index date

 Gender: Female

 Diagnosis: Women who underwent hysteroscopic device sterilization procedure

 Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy

Exclusion criteria: :

 Patients undergoing in-vitro fertilization (IVF) procedures

 Embryo transfer, intrauterine

 Follicle puncture for oocyte retrieval, any method

['Hysteroscopic device placement including Essure (ESS305, BAY1454032)', 'Tubal ligation']


Study and Treatment of Post Lyme Disease (STOP-LD)

Summary: The purpose of this study is to see how well antibiotics work in reducing chronic fatigue symptoms, such as tiredness, in patients that were treated for Lyme Disease. Fatigue is a common symptom of Lyme Disease. When fatigue does not improve after treatment, patients are considered to have Post Lyme Syndrome (PLS). The chronic fatigue seen in these patients appears to be related to the initial infection which causes Lyme Disease. It is believed, but not proven, that treatment with antibiotics may be effective in relieving chronic fatigue in PLS patients.
Inclusion criteria: inclusion criteria:

 You may be eligible for this study if you:

 Are between 18 and 65 years of age.

 Are a resident of Long Island or greater NY metropolitan area.

 Are fluent in English.

 Have a history of Lyme Disease.

 Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study.

 Have severe fatigue.

 Are not pregnant or planning to be pregnant.

Exclusion criteria: :

 You will not be eligible for this study if you:

 Have or have had major medical, neurologic, or psychiatric disorder.

 Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease.

 Have had Fibromyalgia Syndrome.

 Have a history of sleep apnea, narcolepsy, or other serious sleep disorder.

 Have a learning disability.

 Have had head trauma requiring hospitalization.

 Have symptomatic gallbladder disease.

 Are anemic.

 Abuse alcohol or illicit drugs.

 Have been treated with another antimicrobial agent for Lyme Disease within 6 months of study.

 Need to be receiving systemic steroid therapy during drug administration and follow-up.

 Have used benzodiazepines within 1 month of study entry.

 Are allergic to Beta lactams (a class of antibiotics).


240 mL Water Drink Study

Summary: The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. The investigators now want to characterise; in collaboration with the College of Pharmacy at the University of Michigan, the fasting volumes of gastric and small bowel liquid and their time courses over 2 hours after drinking the FDA recommended 240 mL of water drink for oral solid dosage forms testing.
Inclusion criteria: inclusion criteria:

 Apparently healthy; no medical conditions that might affect the study measurements

 Male or female

 Age between 18 and 55 years of age

 Body mass index (BMI) between 18.5 and 24.9 kg m-2

 Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire

Exclusion criteria: :

 Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)

 Known gastrointestinal disease

 Smoking

 History of alcohol or drug abuse

 Taking medication that is likely to affect gastrointestinal function

 Participation in night shift work the week prior to the study day. (Night work is defined as working between midnight and 6 am)

 Strenuous exercise greater than 10 hours per week

 Consumption of more than 21 units of alcohol in a typical week


A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea

Summary: To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients.~Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
Inclusion criteria: inclusion criteria

 Patients must have:

 AIDS diagnosis according to CDC criteria.

 CD4 count less than or equal to 200 cells/mm3 or CD4 count greater than or equal to 200 cells/mm3 and documented cryptosporidiosis for a minimum of 4 weeks.

 Cryptosporidial diarrhea as defined by:

 (1) presence of Cryptosporidium oocytes in a stool specimen within 14 days of enrollment; and (2) chronic diarrhea (i.e., an average of at least 4 bowel movements per day for a minimum of 2 weeks).

 Life expectancy of at least 1 month.

 Ability to tolerate food by mouth.

 Prior Medication:

 Required:

 Any anti-diarrheal or anti-emetic medication for which the dosage regimen has been stable for at least 1 week prior to enrollment.

 Any antiretroviral medications (e.g., zidovudine, ddI, ddC) for which the dosage regimen has been stable for at least 3 weeks prior to enrollment.

 Allowed:

 Medication for prophylaxis or maintenance therapy of opportunistic infection, stable for at least 2 weeks prior to enrollment.

Exclusion criteria:

 Co-existing Condition:

 Patients with the following symptoms or conditions are excluded:

 Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.)

 Patients with the following prior conditions are excluded:

 Presence of Salmonella, Shigella, Campylobacter, Yersinia, Giardia lamblia, Entamoeba histolytica, Microsporidia, Isospora, Cyclospora, or Clostridium difficile toxin in stool (based on assessment within 14 days prior to enrollment by stool ova and parasite examination, culture, and C. difficile assay).

 History of intestinal Mycobacterium avium intracellular infection or intestinal Kaposi's sarcoma.

 History of Cytomegalovirus colitis, unless 28 days of therapy with ganciclovir or foscarnet completed subsequent to diagnosis.

 Prior Medication:

 Excluded:

 Investigational drug therapy within 14 days of enrollment, unless available under an FDA-authorized expanded access program.

 Any drug or therapy with possible anticryptosporidial activity (e.g., paromomycin, spiramycin, azithromycin, clarithromycin, hyperimmune bovine colostrum) within 14 days of enrollment.


Yellow Fever Virus Vaccine and Immune Globulin Study

Summary: The purpose of this study is to determine whether immune globulin can limit the amount of yellow fever vaccine virus present in the blood after vaccination without compromising the immunity associated with the yellow fever vaccine. The study will enroll 80 participants in two groups of 40 each. The first group will receive the yellow fever vaccine with salt-water placebo. The second group will receive yellow fever vaccine with immune globulin. The amount of vaccine virus and immune response in both groups will be compared. Yellow fever vaccine has been used to protect humans against Yellow Fever Vaccine disease since the 1930s.
Inclusion criteria: inclusion criteria:

 Able to understand and give informed consent

 Age 18-40 years old

 No medical contraindications to participation discovered at the screening visit

 Negative serologic test for HIV, HCV and Hepatitis B surface antigen at the screening visit

 Female volunteers of childbearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to any injection.

 Must weigh at least 110 lbs

Exclusion criteria: :

 Any history of allergy or history of anaphylaxis to any of the vaccine components

 Any history of allergic reaction to human immune globulin or a history of IgA deficiency

 History of hypersensitivity to ingestion of eggs or allergic reaction to vaccines prepared in eggs or chick embryo cell cultures (e.g. influenza, measles)

 Known or suspected immunodeficiency (e.g. HIV infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids> 10 mg prednisolone/prednisone, or equivalent, for mare than 14 days in the last three months). Persons with previous skin cancer or cured non-lymphatic tumors are not excluded from the study.

 Any clinically significant chronic medical condition that is considered progressive including: hypertension, diabetes, gastrointestinal abnormalities (e.g. active peptic ulcer disease), cardiac, pulmonary, hepatic, renal, or neurologic disease.

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

 Receipt of any live or inactivated vaccine between the screening visit and the day 0 visit, or any vaccine within 30 days of a vaccination visit

 Any subject found to be HIV positive, hepatitis B surface antigen positive, or hepatitis C antibody positive at the time of screening

 Any contraindication to intramuscular injection

 Women who are pregnant, nursing or expect to become pregnant during the study period

 Administration of a blood product or immune globulin product within 6 months of injection

 History of previous yellow fever, West Nile, dengue, St. Louis encephalitis, Japanese encephalitis or tick-borne encephalitis vaccination or infection

 Serologic evidence of previous yellow fever, West Nile, dengue, St. Louis encephalitis, Japanese encephalitis or tick-borne encephalitis vaccination or infection

 History of travel to a yellow fever endemic zone as defined by the Centers for Disease Control and Prevention. Health Information for International Travel, 2005-2006

 History of thymus disorder or dysfunction, including myasthenia gravis, thymoma, thymectomy, or DiGeorge syndrome

 History of an autoimmune disorder

['YF-VAX® plus saline', '17D YF Vaccine plus Ig,']

YF-VAX® plus saline
17D YF Vaccine plus Ig,


Pregnancy-Related Low Back Pain and Complementary and Alternative Medicine (CAM) Treatment

Summary: This study compares three treatments for low back pain that started during pregnancy. The study hypothesizes that exercise, spinal manipulation, and a mind-body technique called neuroemotional technique (NET) equally affect pain intensity and disability associated with pregnancy-related low back pain. The study also hypothesizes that pain intensity and disability levels do not influence maternal heart rate variability (a measure of stress) and intrauterine attachment (a measure of relationship quality). Ten women will additionally provide blood and salivary oxytocin samples during pregnancy and periodically for three months after birth. These women and their babies will also be videotaped playing for 5 minutes at 2 weeks, 6 weeks, and 3 months postpartum.
Inclusion criteria: inclusion criteria:

 Healthy

 20-49 years old

 Pregnant with a singleton

 Low back pain began during pregnancy and has lasted more than one week

 Low back pain is reproducible with palpation

Exclusion criteria: :

 Health conditions such as hypertension, diabetes, cancer, thyroid condition etc.

 Pain radiates below knee

 Cannot read English

 Plans to move away from Portland area during pregnancy

 Not willing to be randomized to one of the three arms of the study

['Exercise', 'Spinal Manipulation', 'Neuroemotional Technique (NET)']

Exercise
Spinal Manipulation
Neuroemotional Technique (NET)


Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol

Summary: The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis, using a randomized, open-label, parallel-group, comparative design.
Inclusion criteria: inclusion criteria:

 (1) Patients who are currently taking or plan to take oral glucocorticoid medication for 3 months or longer and thus require treatment as per the 'Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and mineral Research (2004),' and who meet at least one of the conditions below. No restriction is imposed on the underlying disease treated with the oral glucocorticoid medication.

 (i) Have any existing insufficiency fracture (ii) %YAM <80 (iii) Oral glucocorticoid daily dose >= 5 mg prednisolone equivalent

 (2) Aged between 20 and 85 years (both inclusive) at consent

 (3) Patients who are able to walk without assistance

 (4) Provided consent to participate in the study

Exclusion criteria: :

 (1) BMD (L1-4 or T-Hip) T score < -3.5

 (2) Have 3 or more vertebral fractures between L1 and L4.

 (3) Have 1 or more SQ grade 3 vertebral fractures, or 3 or more SQ grade 2 vertebral fractures.

 (4) Have received a bisphosphonate preparation for 2 weeks or longer within 6 months before the start of study treatment.

 (5) Have received a bisphosphonate preparation for 2 years or longer within 3 years before the start of study treatment.

 (6) Have received a parathyroid hormone preparation before the start of study treatment.

 (7) Have received one or more doses of an anti-RANKL (receptor activator of nuclear factor-kappa B ligand) antibody.

 (8) Have received one or more doses of an anti-sclerostin antibody or cathepsin K inhibitor.

 (9) Have received any other investigational product (including placebo) within 16 weeks before the start of study treatment in the present study.

 (10) Have received any of the following drugs that can affect bone metabolism within 8 weeks before the start of study treatment, with the exception of calcium preparations: (i) Bisphosphonates (ii) Active vitamin D preparations (including those for topical use) (iii) Selective estrogen receptor modulators (SERMs) (iv) Calcitonin preparations (v) Vitamin K2 preparations (vi) Ipriflavone preparations (vii) Reproductive hormone products (except those for vaginal use such as vaginal tablets and creams) (viii) Other drugs that can affect bone metabolism

 (11) Pregnant woman or woman who desires to become pregnant

 (12) Have corrected serum calcium >= 10.4 mg/dL or < 8.0 mg/dL at enrollment.

 (13) Have corrected urinary calcium > 0.4 mg/dL GF at enrollment.

 (14) Have a past or current history of urinary calculus.

 (15) Have eGFR < 30 mL/min/1.73 m2 at enrollment.

 (16) Have severe liver disease such as cirrhosis or severe heart disease such as severe cardiac failure.

 (17) Have active malignancy or received treatment for malignancy, including adjuvant therapy, within the past 3 years.

 (18) Have a history of hypersensitivity to eldecalcitol, alfacalcidol, or other vitamin D preparations.

 (19) Other persons judged by the investigator (or subinvestigator) to be inappropriate to participate in this study.