Immunogenicity and Safety of Comvigen (Bivalent) Vaccine

This phase II study assesses the safety, reactogenicity, and immunogenicity of a single dose of COMVIGEN or BIVALENT Pfizer/BNT vaccine as a booster in healthy adults who previously received an mRNA COVID-19 booster ≥3 months ago. 450 subjects will be randomized in a 2:1 ratio and monitored across multiple sites in Thailand.

['COMVIGEN Vaccine', 'BIVALENT Pfizer/BNT Vaccine']

COMVIGEN Vaccine
BIVALENT Pfizer/BNT Vaccine

Participants aged 18–64, completed at least 2 doses of an approved mRNA COVID-19 vaccine (≥3 months prior), negative SARS-CoV-2 rapid antigen test on Day 1, general good health, not pregnant or breastfeeding, willing to follow contraception protocol, and abstain from donating blood or organs during the study.

Systemic hypersensitivity to vaccines, COVID-19 infection within 3 months, unstable acute or chronic illness, serious vaccine-related side effects, bleeding disorders, immunosuppression, or recent investigational drug use.


Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM) (MagnetisMM15)

This is a post-trial access study for patients with multiple myeloma who completed Pfizer-sponsored elranatamab trials and continue to benefit clinically. Patients will continue elranatamab until progression, toxicity, or commercial availability.

Participants must have completed a qualifying parent study, were receiving elranatamab at its conclusion, and were deriving clinical benefit. Must agree to reproductive protocol compliance.

Participants with recent psychiatric illness, active suicidal ideation, or lab abnormalities posing risk, and those not previously enrolled or who discontinued treatment in a parent study.


The Impact of COVID-19 on Maternal and Neonatal Outcomes

This observational study aims to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection and vaccination. It investigates how pregnancy and lactation influence immune responses, including antibody and T-cell activity, following mRNA COVID-19 vaccination in pregnant individuals.

['mRNA COVID-19 vaccine (Pfizer or Moderna)']

Pregnant women aged 14-55 receiving prenatal care or admitted for delivery at Johns Hopkins Hospital or Bayview Medical Center. Vaccine arm: planning to receive mRNA COVID-19 vaccine during pregnancy. Sample collection arm: admitted for delivery with or without history of COVID-19 during pregnancy.

Vaccine arm only: prior COVID-19 infection.


Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively

This phase 3, long-term, multi-country observational study aims to assess the safety and durability of gene therapy in participants with Hemophilia A or B who previously received investigational treatment in Pfizer-sponsored trials. Outcome measures include bleed frequency, liver function, and vector integration over extended follow-up.

['Giroctocogene fitelparvovec', 'Fidanacogene elaparvovec']

Giroctocogene fitelparvovec
Fidanacogene elaparvovec

Adult male participants (≥18 years) with Hemophilia A or B who were treated with either giroctocogene fitelparvovec or fidanacogene elaparvovec in a prior Pfizer-sponsored clinical study (C0371002, C0371003, C0371005, C3731001, or C3731003).


A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1)

This Phase 3 study evaluates the safety and efficacy of PF-06821497 (Mevrometostat) in combination with enzalutamide versus physician's choice of enzalutamide or docetaxel in men with metastatic castration-resistant prostate cancer who have progressed following abiraterone treatment.

['Metastatic Castrate Resistant Prostate Cancer (mCRPC)']

Men 18+ years with histologically confirmed prostate adenocarcinoma without small cell features, documented metastatic disease (bone or soft tissue), progression after abiraterone treatment, ECOG 0–2, and life expectancy ≥6 months.

History of cardiovascular disease, GI disease, seizures, prior cytotoxic or systemic ARSi therapy, prior investigational drug in past 30 days, or inadequate organ function.


Vaccine Responses in Patients With B Cell Malignancies

This Phase 4 study evaluates vaccine responses in patients with B cell malignancies (e.g., CLL, FL, WM) who are either untreated, off treatment, or receiving targeted therapies such as BTK or BCL-2 inhibitors. Participants receive one or more vaccines and provide blood samples to assess immune response. Vaccine schedules and follow-up extend up to 5 years.

['Fluzone', 'Shingrix', 'Flucelvax', 'Afluria', 'PREVNAR 13', 'Heplisav-B', 'Pfizer COVID-19 Vaccine']

Fluzone
Shingrix
Flucelvax
Afluria
PREVNAR 13
Heplisav-B
Pfizer COVID-19 Vaccine

['Chronic Lymphocytic Leukemia (CLL)', 'Follicular Lymphoma (FL)', 'Mantle Cell Lymphoma (MCL)', 'Marginal Zone Lymphoma (MZL)', 'Waldenstrom Macroglobulinemia (WM)', 'Indolent NHL NOS']

Chronic Lymphocytic Leukemia (CLL)
Follicular Lymphoma (FL)
Mantle Cell Lymphoma (MCL)
Marginal Zone Lymphoma (MZL)
Waldenstrom Macroglobulinemia (WM)
Indolent NHL NOS

Diagnosis of CLL, FL, MCL, MZL, WM, or NHL NOS; age ≥18; eligible for one of five CLL or NHL arms based on treatment history; negative hepatitis B titer if receiving HEPLISAV-B; able to provide informed consent.

Current pregnancy; severe allergy to vaccines; life-threatening comorbidity; recent chemotherapy or IVIG; monoclonal antibody within 6 months; cellular therapy within 12 months; stem cell transplant history.


The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery

This prospective, randomized, double-blinded trial investigates the effect of systemic and local tranexamic acid on postoperative ecchymosis and edema in patients undergoing orbital surgery. Patients are assigned to intravenous TXA, subcutaneous TXA, or placebo. Edema and ecchymosis are assessed from standardized postoperative photographs by blinded graders.

['Tranexamic Acid injection', 'Tranexamic Acid in NaCl', 'Normal saline - injection', 'Normal saline - intravenous']

Tranexamic Acid injection
Tranexamic Acid in NaCl
Normal saline - injection
Normal saline - intravenous

Patients aged 18+, undergoing orbital surgery (e.g. decompression, fracture repair), and able to provide consent.

History of prior orbital surgery, multiple simultaneous periocular procedures, active infection, bleeding or clotting disorder, TXA allergy, anticoagulant use within 7 days, or existing orbital edema.


Antibiotics as Adjuncts to Periodontal Therapy: Pharmacokinetic Considerations and Dosing Strategies (AMA)

Periodontitis is a bacteria-induced inflammatory disease that leads to tooth loss. Mechanical debridement is often insufficient for complete bacterial elimination, necessitating adjunctive antibiotic use. This study optimizes the dosage and duration of amoxicillin/metronidazole and azithromycin to limit resistance and improve outcomes. The pharmacokinetics (PK) and pharmacodynamics (PD) of these regimens will be measured in gingival crevicular fluid (GCF), saliva, and serum. Patients receive either 3-day or 7-day antibiotic courses, and biological samples are collected over time to assess concentration and microbial impact.

Informed Consent as documented by signature
Aged 18-80 years old with need of periodontal treatment associated with adjunctive antibiotic therapy
Presence of at least 30% of the teeth in the mouth with PD>6mm and BOP

Persons with systemic illnesses (e.g., uncontrolled diabetes, cancer, HIV, etc.)
Pregnancy or lactation
Use of antibiotics in the past 2 months
Use of NSAIDs
Intolerance to 5-nitroimidazoles, amoxicillin, or macrolides
Periodontal therapy in the last year
Non-compliance, language barrier, or psychological limitations
Recent participation in other investigational drug studies


A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study

The goal of this clinical trial is to evaluate whether antibiotic treatment (macrolides like azithromycin) is necessary in children with Mycoplasma pneumoniae-induced community-acquired pneumonia (CAP), by comparing outcomes with a placebo group. The study will assess duration of symptoms and overall health recovery between groups.

['Community-acquired pneumonia in children', 'Mycoplasma pneumoniae']

Children aged 3–17 years with clinical diagnosis of community-acquired pneumonia (CAP), including fever ≥38°C, tachypnea above age-specific thresholds, and physician-confirmed CAP. Positive IgM test required for intervention. Written consent required.

History of recurrent or severe pneumonia, underlying chronic lung disorders (excluding asthma), immunodeficiency, contraindication to azithromycin, prior macrolide use in last 7 days, ICU referral, or inability to follow oral medication or study follow-up.


Medroxyprogesterone Acetate vs LNG-IUS in Early-stage Endometrioid Carcinoma and Atypical Hyperplasia Patients

This study evaluates the efficacy and safety of medroxyprogesterone acetate (MPA) versus a levonorgestrel-releasing intrauterine system (LNG-IUS) in preserving fertility in young women with early-stage endometrioid carcinoma or atypical hyperplasia. It aims to support fertility-sparing treatment strategies in patients with favorable tumor biology.

['Medroxyprogesterone Acetate', 'Levonorgestrel-Releasing Intrauterine System']

['Early-stage endometrioid carcinoma', 'Atypical hyperplasia']

Early-stage endometrioid carcinoma
Atypical hyperplasia

Women aged ≤45 years with highly differentiated endometrioid adenocarcinoma confined to the endometrium, normal CA125, strong ER/PR positivity, no suspicious metastatic lesions, and a strong desire to preserve fertility. Conditional follow-up agreement required.

Type II endometrial cancer, abnormal liver or kidney function, other active malignancies, inability to provide consent, or unwillingness to comply with follow-up.


British Axial Spondyloarthritis Cohort (BAxSIC)

The BAxSIC study is a prospective observational cohort aimed at evaluating the impact of diagnostic delay on outcomes in patients newly diagnosed with axial spondyloarthritis (axSpA). The study will assess functional, pain, fatigue, work-related, and therapeutic outcomes over time in biologic-naïve patients.

Patients aged ≥16 years with a physician diagnosis of axial spondyloarthritis (axSpA), including ankylosing spondylitis, within 6 months prior to baseline. Must be willing and able to provide informed consent.

Age <16 years. Inability to provide informed consent or communicate in English.


Evaluating the Safety and Efficacy Civamide in Osteoarthritis (OA) of the Knee(s)

Summary: To evaluate the safety and efficacy of Civamide Cream 0.075% as a treatment of the signs and symptoms associated with osteoarthritis of the knee.
Inclusion criteria: inclusion criteria:

 Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to entry into the Screening Period (Day -3).

 Subject has OA pain of the Target Knee with a WOMAC Pain Subscale baseline value of > 9 at the Baseline/Randomization Period (Maximum score is 20 for 5 questions with 0 = none; 4 = extreme.

 Subject must have a Functional Capacity Classification of I-III.

 Subject has taken a stable dose of NSAIDs or COX-2 inhibitor agents for OA pain for at least 22 of the previous 28 days and for each of the 2 days prior to the Screening Period (Day -3) and for at least each of the 2 days prior to the Baseline/Randomization Period (Day 1). Subject must also, agree and be expected to remain on this stable daily dose throughout the study.

 Subject is between 40-75 years of age.

 Diagnosis of OA is present for at least 6 months according to the ACR criteria for OA of the knee.

 Radiographic evidence of OA of the Target Knee (within the last 3 years) with a Kellgren-Lawrence scale of 2 or 3.

 Subject is generally in good health.

 Subject is expected to be compliant with study procedures.

 Females of child-bearing potential must have a negative urine pregnancy test at Screening.

 Female subjects of child-bearing potential agree to use an approved form of contraception and must be on the same contraceptive method and dosage schedule during the entire study.

Exclusion criteria: :

 Presence of tendonitis, bursitis, partial or complete joint replacement of Target Knee.

 Presence of active skin disease, erythema, infection, wound or irritation near the treatment area of the Target Knee.

 Subject has history of frequent headache or other painful conditions (other than OA) that is expected to require any use of systemic opiates or derivatives, or more than twice a week additional administration of different oral NSAIDs or COX-2 inhibitors (see Section 6.1, Table 2).

 Subject experiences regular significant pain due to osteoarthritis or other conditions in the non-target knee or other joints while on stable doses of their current analgesic therapy.

 Subject has an anticipated need for any surgical or other invasive procedure that will be performed on the Target Knee or other part of the body during the course of the study.

 OA secondary to local joint disorders (e.g., mechanical disorder, internal derangement of the knee), systemic metabolic disease, endocrine disorders, bony dysplasia, calcium crystal deposition disease, neuropathic arthropathy, frostbite, congenital abnormalities.

 Subject has history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease.

 Subject has active (redness, swelling, fever, etc.) gout/pseudogout within 6 months prior to screening.

 Subject has Type I or Type II diabetes with peripheral neuropathies.

 Subject is extremely obese with BMI ≥ 39.

 Subject has had trauma to or surgery on the Target Knee within 1 year of Screening/Baseline.

 Subject has an underlying clinical condition, including previous malignancies that in the Investigator's judgment, is unstable.

 Subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation.

 Subject has a history of substance abuse within the past 12 months.

 Subject has participated in previous clinical study with Civamide Cream.

 Use of restricted medications (See Medication/Treatment Table, Section 5.1.2).


Lithium Therapy: Understanding Mothers, Metabolism and Mood

Summary: Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation to medication therapy for Major Depression, is commonly continued in pregnancy due to its therapeutic benefit and more recent data that suggests the teratogenic effects of lithium are less than historically believed. Due to the increased elimination of lithium during pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the risk for postpartum exacerbation of BD and psychosis. Our study will investigate the pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum. Twenty women taking lithium in pregnancy or planning to become pregnant and continue lithium will be invited to participate in a study to measure repeated blood levels of lithium at six time points between preconception and 3 months postpartum. The data collected will inform the dose, timing of dose, and frequency of dosing of lithium that will lead to fewer untoward effects for the mother and baby. Change in elimination clearance of lithium will be correlated with symptom worsening to develop a dosing algorithm that will help maintain wellness for pregnant women with mood disorders.
Inclusion criteria: inclusion criteria:

 Age 18 or older

 If Pregnant, equal to or less than 26 weeks

 English-speaking

 DSM-IV Bipolar Disorder, any subtype, Major Depressive Disorder, or Mood Disorder Not Otherwise Specified

 Able to provide informed consent

 Daily dosing of lithium

Exclusion criteria: :

 Active substance abuse within last 6 months and/or positive urine drug screen

 Active suicidality

 No obstetrical care

 Use of other drugs that affect metabolism of lithium

 Medications in FDA categories F or X that are not antimanic drugs

 Chronic Kidney Disease


Comparative Study of a Smartphone-Linked Self-Monitoring System Versus a Traditional One for Improving Metabolic Control and Compliance to Self-Monitoring of Blood Glucose

Summary: The purpose of this study is to demonstrate the superiority of iBGstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. The study is intended also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs. usual blood glucose self-monitoring system for improving the compliance to self monitoring of blood glucose after 6 months.
Inclusion criteria: inclusion criteria:

 Type 1 diabetes

 Males and females

 Age between 14-24 years

 Any diabetes duration

 Cared for by the diabetes center for at least 1 year

 HbA1c ≥ 8%

 Basal bolus treatment (any insulin)

 Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recommended Blood Glucose measurements recorded in the glucose meter in the two previous weeks, i.e. <16 Blood Glucose measurements in the last two weeks)

 Written informed consent obtained from patient or legal representative (for minor)

Exclusion criteria: :

 Treatment with other insulin regimen or Continuous Subcutaneous Insulin Infusion

 Refusal or inability to give informed consent to participate in the study

 Patients with short life expectancy

 Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment

 Requirement for concomitant treatment that could bias primary evaluation

 Patients with high likelihood of being unavailable for 6 and/or 12 months visits

 Subject is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study

 Current addition/abuse of alcohol or drugs

 Severe visual or dexterity impairment

 Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study

 Pregnant or breast-feeding women

 Subjects unlikely or unable to comply with the Protocol requirements


Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma

Summary: This study is designed to help decide whether a CAT scan performed at a very low dose of radiation (Minimum dose CT scan) is better than a Chest X-Ray in detecting recurrence of lung cancer in the chest (after surgery).
Inclusion criteria: inclusion criteria:

 lung cancer patients undergoing resection with intent to cure

Exclusion criteria: :

 age < 18 years

['Minimum Dose Computed Tomography (MnDCT) scan']


Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease

Summary: Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate. So far, treatment strategies focused on the preservation of life and limb by an open surgical or endovascular revascularization, together with cardiovascular risk management and pain relief. Important modifiable factors related to mortality and morbidity are not covered in the current national and international guidelines. This study investigates the effects on mobility, mortality and quality of life with supplementation of the standard treatment of critical limb ischemia with supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor management and lifestyle coaching will be taken in to account. The supervised exercise therapy will take place under the supervision of a trained physiotherapist.
Inclusion criteria: inclusion criteria:

 Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention.

 Patients with both legs are affected, but the most severe leg does not exceed stage 5.

Exclusion criteria: :

 Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh.

 Patients with limited amputation of the toes can participate.

 Insufficient understanding of the Dutch language.

 No physiotherapy insurance.

['Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization']


Vocal Warm-up and Respiratory Muscle Training

Summary: The purpose of this study is to verify the effects of two speech-pathology interventions: vocal warm-up and respiratory training in teachers who work in a public school of the city of Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and the hypothesis is that both approaches can produce positive voice changes, but the Vocal Warm-up will produce the most significant changes.
Inclusion criteria: inclusion criteria:

 Age between 20-60.

 No occurence of speech therapy simultaneously to the intervention

Exclusion criteria: :

 Professional voice use in another activity;

 Frequent use of alcohol and tobacco;

 Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research.

['Vocal Warm-up', 'Respiratory Muscle Training']

Vocal Warm-up
Respiratory Muscle Training


Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder

Summary: To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation
Inclusion criteria: inclusion criteria:

 Provision of written informed consent before initiation of any study related procedures. Patients who are deemed incapable of providing informed consent maybe enrolled if written informed consent has been obtained from the patient's Legally Authorized Representative.

 Documented clinical diagnosis meeting the DSM-IV criteria for any of the following:

 296.4X Bipolar I Disorder, Most Recent Episode Manic

 296.0X Bipolar I Disorder, Single Manic Episode

 Have a YMRS score of at least 20 and a score of at least 4 on 2 of the following 4 YMRS items both at enrolment and at randomisation: Irritability, Speech, Content, and Disruptive/Aggressive Behaviour.

 Female patients of childbearing potential must have a negative urine pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e., barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation, during the study.

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

Exclusion criteria: :

 Manic episode judged to be either:

 the direct physiological consequence of a treatment or medical condition other than Bipolar disorder.

 the direct physiological effect of a substance of abuse; intoxication with hallucinogens, inhalants, opioids, or phencyclidine and related substances.

 the direct physiological effect of psychostimulant or antidepressant medication.

 Evidence of clinically severe or active disease, or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.

 History of seizure disorder, except febrile convulsions.

 Hospitalization period of 3 weeks or longer immediately prior to randomization for the index manic episode.

 Known history of intolerance or hypersensitivity to quetiapine or lithium, or to any other component in the tablets/capsules.

 Known lack of response to quetiapine or lithium, as judged by the investigator.

 Use of antipsychotic medication or mood stabilizer other than quetiapine and lithium at the day of randomisation (to be tapered to discontinuation between the enrolment visit and randomisation).

 Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before randomisation.

 Use of clozapine within 28 days prior to randomisation.

 Use of antidepressants during the enrolment period or within a period of 5 half-lives of the drug(s) prior to randomisation.

 Continuous daily use of benzodiazepines in excess of 4 mg per day of lorazepam, or the equivalent, during 28 days prior to randomisation.

 Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes within 14 days before randomisation.

 Receipt of electroconvulsive therapy (ECT) within 28 days prior to randomisation.

 Clinically significant deviation from the reference range in clinical laboratory test results at enrolment, as judged by the investigator.

 An absolute neutrophil count (ANC) of <1.5X109/L.

 Treatment with quetiapine with a dosage of at least 50 mg/day at enrolment (Visit 1)

 Liver function test AST or ALT 2 times as the upper normal limit.

 A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism.

 Known diagnosis of Diabetes Mellitus (DM) or fasting blood glucose level > the upper normal limit.

 Risk of transmitting human immuno-deficiency virus (HIV) or hepatitis B via blood or other body fluids, as judged by the investigator.

 ECG results considered to be clinically significant as determined by the investigator.

 Conditions that could affect absorption and metabolism of study medication.

 Patients who in the investigators opinion will require systematic psychotherapy (other than supportive psychotherapy) during the study period.

 Participation in another clinical study or compassionate use programme within 28 days prior to randomisation, or longer if locally required.

 Involvement in the planning and conduct of the study (applies to all AstraZeneca or staff at the investigational site).

 Previous enrolment or randomisation of treatment in the present study.


Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

Summary: The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
Inclusion criteria: Key inclusion criteria:

 Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features

 Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole

 Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline

 Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.

 Key
Exclusion criteria: :

 Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product

 A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder

 Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)

 Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania

 Thyroid pathology

 Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.

 History of neuroleptic malignant syndrome from antipsychotic agents

 Manic symptoms that investigator considers refractory to treatment

 Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms

 Significant risk of suicide based on history, mental status exam, or investigator judgment.

['Aripiprazole', 'Placebo', 'Lithium', 'Valproate']


Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

Summary: Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown.This randomised double-blind placebo-controlled trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD recruited from general practice. Participants will have a clinical and spirometric diagnosis of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler) or an identical placebo inhaler. Patients will be monitored using diary cards for a year with 3 monthly follow-up visits at their general practice. The primary outcome measures will be exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs, health status, lung function and unscheduled care. We tested the hypothesis that withdrawal of ICS in this population would lead to an increased number of exacerbations, earlier onset of exacerbation, and a worsening of symptoms.
Inclusion criteria: inclusion criteria:

 Smoker or ex smoker of at least 10 pack years

 Age 40 or above

 Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning)

 FEV1 <80% of predicted, FEV1/FVC ratio <70%.

 Less than 15% change and <200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol.

 256 patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year

Exclusion criteria: :

 Clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease

 Inability to give informed consent (severe mental illness, mental handicap or brain damage).

 Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation)

 Classification as a never smoker

 Strongly positive skin allergy result (>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)

['Fluticasone 500mcg BD via accuhaler or identical placebo']

['Chronic Obstructive Pulmonary Disease']


Parents With Bipolar Disorder: Relationship of Adaptation to Own Illness With Risk Perception and Coping With Perceived Risk to a Child

Summary: Background:~Bipolar disorder is a common mood disorder that affects 1% to 2% of the population. Individuals with bipolar disorder tend to have periods of mania that are characterized by extra energy, very poor judgment or unrealistic beliefs about their thoughts and abilities, and an inability to complete thoughts and tasks; as well as major depressive episodes. The range and frequency of symptoms in affected individuals can vary greatly. Most individuals have cyclical symptoms and spend more time in a normal mood state than in an overtly symptomatic state.~Relatives of individuals with bipolar disorder have an increased risk for bipolar disorder and other mood disorders. Currently, risk assessment for recurrence of a mood disorder is based on family and medical histories; genetic testing has not proved particularly useful to date for assessing risks of a mood disorder.~Despite its prevalence, there is limited research on coping with bipolar illness. No published studies have examined adaptation to living with bipolar disorder or risk for bipolar disorder. More specifically, though a positive family history is the most important known risk factor for bipolar disorder, there are no published studies about response to the threat of future illness onset in children, risk modification efforts undertaken by affected parents, or coping with the risk for illness in children.~Objectives:~To examine parents appraisals of the impact and cause of bipolar disorder, and the association with their perceived risk for bipolar illness in their child and how they cope with their perception of risk to their child.~To assess whether parents adaptation to their own illness is associated with coping with perceived risk to their child.~To describe parents coping strategies related to perceived risk in their children.~Eligibility:~- Men and women at least 18 years of age who have been diagnosed with bipolar disorder and who have at least one biological child (30 years of age or younger). Participants must be a primary caregiver for their children.~Design:~Participants in this study will take an online survey and answer questions about disease perceptions, coping strategies, and adapting to a diagnosis of bipolar disorder, addressing issues such as the following:~Assessing the threat of bipolar disorder and coping with one s own illness.~Optimism/pessimism of the individual coping with the illness.~Perception of risk to a child, and coping with the perceived risk.~Data from this study will not be shared with the participants/respondents.
Inclusion criteria: inclusion criteria:

 Have a diagnosis of bipolar disorder

 Be 18 years or older

 Be a biological parent of a child who is younger than 30 years old

 Be willing to participate in the survey

 The participant must be (or must have been) the primary caretaker for his or her child.

Exclusion criteria: :

 A participant must meet inclusion criteria.

 A participant s child cannot have been diagnosed with a mood disorder or other serious psychiatric disorder.

 A participant s child cannot have been adopted.

 The participant s child cannot be 30 years of age or older.


Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study

Summary: The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.
Inclusion criteria: inclusion criteria:

 hemodialysis patients with hyperphosphatemia who require phosphate binders

 hemodialysis for more than 3 months

 patients who have at least one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus)

 intact-PTH < or = 240pg/mL

 life expectancy > 1 year

 with written informed consent

Exclusion criteria: :

 contraindications to lanthanum carbonate and calcium carbonate

 swallowing disorders

 severe GI disorders

 history of obstructed bowels

 history of IHD/stroke within 6 months before randomization

 NYHA classification Ⅲ-Ⅳ

 severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution

 require treatment of arrhythmia

 severe malnutrition

 malignancy of any type within the last five years

 peritoneal dialysis patients

 pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term

 ineligible patients according to the investigator's judgment

['Lanthanum Carbonate', 'Calcium Carbonate']


Natural History of Cytomegalovirus (CMV) Infection and Disease Among Renal Transplant Recipients

Summary: Although the accumulated knowledge regarding Cytomegalovirus (CMV) infection increased substantially over the past years, several issues still deserve further investigation. The epidemiology of this disease has been changing, perhaps influenced by new immunosuppressive strategies currently used and growing and widespread use of prophylaxis. The knowledge of the CMV viral load kinetics, using a polymerase chain reaction (PCR-based assay), among renal transplant recipients not receiving any prophylactic therapy will allow the determination of risk factors for and the impact of earlier intervention on CMV infection and disease. The goal is to ultimately improve the clinical outcomes for renal transplant recipients.
Inclusion criteria: inclusion criteria:

 Informed consent.

 Male/female patients at least 18 years old who will be followed at our outpatient clinic for at least one year.

 Recipients of first or repeat kidney transplants from living or deceased donors.

Exclusion criteria: :

 Recipients of any combined transplant (kidney/pancreas, kidney liver).

 Unlikely to comply with the requirements of the study.

['Infection in Solid Organ Transplant Recipients']


Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

Summary: The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.
Inclusion criteria: inclusion criteria:

 age >15 years

 erythema migrans in 4 months period before neurologic symptoms

 normal CSF cell count

 absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).

Exclusion criteria: :

 pregnancy

 lactation

 allergy on doxycycline and ceftriaxone

 immune deficiency.

['Suspected Early Lyme Neuroborreliosis']


Anti-CD20 in Systemic Lupus Erythematosus

Summary: The purpose of this study is to determine the safety and effectiveness of rituximab (anti-CD20) in treating systemic lupus erythematosus (SLE).~White blood cells in the body called B cells give off substances that are active in promoting SLE disease. Researchers have found that anti-CD20 can block production of these substances in another disease. This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE.
Inclusion criteria: inclusion criteria

 People may be eligible for this study if they:

 Are 18 to 70 years of age

 Agree to use a reliable method of birth control during treatment and for 6 months after treatment ends

 Have SLE (by the American College of Rheumatology criteria)

 Have had SLE for at least 6 months prior to screening

 Have active SLE disease at the screening visit

 Have organ disease (lung, stomach, intestinal, blood, kidney, and/or heart)

 Have failed standard therapy, including at least 1 immunosuppressive agent, or have experienced side effects from an immunosuppressive agent that required discontinuation of treatment

 Meet blood, liver, and kidney laboratory values set by the protocol

 Have not taken an immunosuppressive agent for 2 weeks prior to the first treatment

 Have been on a stable dose of oral corticosteroids, if taking them, for 4 weeks before the first week's visit. Oral corticosteroids may be altered as medically necessary after enrollment.

 Have at least 1 elevated autoantibody level at screening visit.

Exclusion criteria:

 People will not be eligible for this study if they:

 Are pregnant or breast-feeding

 Have heart, lung, nervous system, kidney, liver, stomach, intestinal, or other diseases that may place the patient at risk if participating in the trial

 Have cranial neuropathy (a condition affecting the head region)

 Are on blood-thinning agents to prevent blood clotting

 Have a serious skin disease

 Have a certain class of heart disease

 Have had cancer, unless surgically cured basal cell carcinoma or cervical dysplasia

 Have a long term serious infectious disease such as tuberculosis or a fungal infection that is now active, or active within 2 years of the baseline visit

 Have had HIV infection or another immunosuppressive state (chemotherapy or radiation therapy)

 Have received any experimental drug within 30 days of baseline visit

 Have received any monoclonal antibody or similar medication within 3 months of the baseline visit

 Received any intravenous, joint, or muscle injection of corticosteroids within 4 weeks of the baseline visit

 Abuse alcohol or drugs

 Are unwilling or unable to follow the protocol

 Have poor veins for receiving injections.


Water Immersion in Right-Sided Heart Failure: A Pilot Study

Summary: This is an unblinded pilot study comparing (against a randomized control day without water immersion) the diuretic and natriuretic effects of water immersion in patients with right heart failure.
Inclusion criteria: inclusion criteria:

 Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation

 Age greater than 18 years of age

 Right heart catheterization within the last year to rule out left-sided failure.

 Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites

Exclusion criteria: :

 Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures.

 Serum creatinine > 2.0

 Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study.


PROTECT Continued Access Post Marketing Surveillance Trial

Summary: In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is PROTECT CONTINUED ACCESS (PROTECT CA).
Inclusion criteria: inclusion criteria:

 Patient is > 18 years of age (or minimum age as required by local regulations).

 The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the Patient Informed Consent Form.

 All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System.

 Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System. Please check the 'Instructions for Use' that comes with the product. Please be aware that the 'Instructions for Use' may be subject to change during the course of the study.

 5 The patient is willing and able to cooperate with study procedures and required follow up visits.

Exclusion criteria: :

 Women with known pregnancy or who are lactating.

 Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.

 Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.

 Previous brachytherapy.

 Previous implantation of a drug eluting stent.

 Previous implantation of a bare metal stent in the preceding year.

 Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.

 Current medical condition with a life expectancy of less than 3 years.

 Manifest acute severe heart failure (Killip class III-IV).

 The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once.

 Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.

 Patients on warfarin or similar anti-coagulant therapy.

 Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use.

 Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.

 Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.

 16 Transplant patients.

['Endeavor® Zotarolimus Eluting Coronary Stent System']

['Coronary Artery Disease, Autosomal Dominant, 1']

Coronary Artery Disease
Autosomal Dominant
1


Evaluate the Nephrotoxicity by 6% Hydroxyethyl Starch 130/0.4 in Old Patients During Orthopaedic Surgery

Summary: Hydroxyethyl starch (HES) is commonly used as plasma expander during surgery but may be nephrotoxic as seen in studies in patients with sepsis. The investigators hypothesized that the possible nephrotoxicity of 6% HES 130/0.4 could be revealed by measurements of urinary and plasma neutrophil gelatinase-associated lipocalin and interleukin-18 (IL-18) in old patients with normal renal function during orthopaedic surgery.
Inclusion criteria: inclusion criteria:

 Old patients scheduled to undergo orthopaedic surgery under a intravertebral anesthesia. (American Society of Anesthesiologists physical status I-Ⅲ)

Exclusion criteria: :

 Allergy and contraindication to HES

 Infections and malignancies

 Sepsis

 History of heart failure or New York Heart Association(NYHA)>Ⅲ

 Renal failure or Cr>108μmol/L，BUN>8.3mmol/L

 Undergoing dialytic treatments

 Intracranial hemorrhages

 Taking non-steroidal antiinflammatory agent for a long time

 Inability to understand the Study Information Sheet and provide a written consent to take part in the study

['Hydroxyethyl Starch', 'Lactate Ringers']


The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition

Summary: Specific Aim 1: To compare effects of Vitamin D supplementation to usual care on symptoms in women transitioning to early postmenopause and determine the associated effect size in order to conduct a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in early postmenopause who are randomized to supplementation, titrated to achieve sufficiency for 2 months, will have fewer symptoms including hot flashes, mood, and musculoskeletal complaints than women randomized to usual care.~Specific Aim 2: To compare effects of Vitamin D supplementation to usual care on body composition (by dual-energy x-ray absorptiometry [DXA] and by weight, BMI, waist to hip ratio) in overweight/obese women transitioning to early postmenopause and determine the associated effect size for a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in the menopausal transition randomized to supplementation, titrated to achieve sufficiency for 9 months, will improve DXA body composition (less total body and abdominal fat), compared to women in usual care, who will have increased body weight, including total and abdominal fat.~Specific Aim 3: To estimate the proportion of overweight/obese middle-aged women who achieve sufficiency by 1 month versus 2 or more months and to determine if achieving sufficiency by 1 month varies by baseline characteristics. Hypothesis: About 80% of participants will achieve sufficient Vitamin D level by 1 month. Those who need more than 1 month for sufficiency will have lower baseline levels and higher initial BMI.
Inclusion criteria: inclusion criteria:

 Women in late menopausal transition or early menopause

 Age 40-55

 BMI >25 kg/m2

 Suffer from menopausal symptoms

 Change in previously regular cycles consisting of at least ≥2 skipped cycles and an interval of amenorrhea (≥60 days) in the last year

 Negative pregnancy test

 Vitamin D insufficiency (<30 ng/ml)

 Weight stability (+/- 5%) for 3 months

Exclusion criteria: :

 No period for >12 months

 Hormone use (i.e. menopausal hormone therapy, oral contraceptive, other hormonal medications) in last 3 months

 History of hysterectomy more than 11 months ago

 Abnormal screening blood tests (i.e. elevated serum calcium level, elevated creatinine)

 History of medical conditions where Vitamin D supplementation is not indicated (i.e. chronic renal insufficiency, elevated calcium, sarcoidosis or other granulomatous disease, lymphoma, or tuberculosis

 History of osteoporosis or osteoporosis on baseline DXA (expect less than 4% of screened population)84

 Vitamin D deficiency (<10 ng/ml) as we felt it was unethical to withhold supplementation for 12 months in severe deficiency (according to our KPNW survey, this will exclude <2% of population)

 Consuming more than 400 IU of Vitamin D supplementation daily (we felt such doses taken outside of the study design could confound results)

 Current smoker (within the last year)

 Taking medications that affect body weight

 Prior bariatric surgery

 Taking medications or herbal supplements that affect mood (i.e. antidepressants) or menopausal symptoms (i.e. herbal meds) or sleep

 Weighing more than 400 pounds (cannot fit on DEXA scan)

 Not fluent in English or cognitively impaired

['Menopause, Premature', 'Hot Flushes', 'Obesity', 'Vitamin D Deficiency']

Menopause
Premature
Hot Flushes
Obesity
Vitamin D Deficiency


Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea

Summary: Retrospectively review the charts of all children who had heart rate variability, deep breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing, quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's Hospital of Wisconsin.
Inclusion criteria: inclusion criteria:

 Outpatient services

Exclusion criteria: :

 Inpatient services

['Vomiting Syndrome', 'Irritable Bowel Syndrome', 'Postural Orthostatic Tachycardia Syndrome', 'Abdominal Pain', 'Chronic Nausea']

inclusion criteria:

 Outpatient services


Antiplatelet Therapy to Prevent Stroke in African Americans

Summary: The African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent strokes by administration of aspirin or ticlopidine. The study also provides community information on reducing risk of stroke and recognizing the symptoms of stroke. The study involves more than 50 participating hospitals located throughout the United States. Study medication is provided free of charge, and a transportation stipend is available for those in need.
Inclusion criteria: inclusion criteria:

 African Americans are eligible if they had a non-cardioembolic ischemic stroke at lease 7 days, but no more than 90 days before entering the trial.

 African American

 29-85 years of age

 Non-cardioembolic cerebral infarct

 Onset of entry stroke at least 7 days but no more than 90 days

 CT or MRI following entry stroke and consistent with occurrence of entry stroke (i.e., shows entry infarct, shows old infarct, or shows no infarct) Measurable neurologic deficit that correlates with onset of entry stroke.

 Informed consent

 Able to follow outpatient treatment program

Exclusion criteria: :

 Volunteers with transient ischemic attack (TIA) as the potentially qualifying event, intracranial hemorrhage, nonatherosclerotic stroke, sensitivity or major allergy to the study drugs, Modified Barthel Index < 10 or childbearing potential are not eligible.

 Non-qualifying entry events: TIA, subarachnoid hemorrhage, cardiac embolism, iatrogenic stroke, postoperative stroke within 30 days of operation, and carotid endarterectomy as preventive treatment of entry stroke.

 Mean arterial blood pressure > 130mmHg on 3 consecutive days

 Modified Barthel Index < 10

 History of dementia or neurodegenerative disease

 Severe comorbid condition such as cancer that would limit survival during 2 year follow-up period

 Concurrent enrollment in another clinical trial

 Sensitivity or allergy to aspirin or ticlopidine

 Women of childbearing potential

 Peptic ulcer disease, active bleeding diathesis, lower gastrointestinal bleeding, platelet or other hematologic abnormality currently active or clinically active in the past year, hematuria, positive stool guaiac, prolonged PT or PTT, BUN > 40mg%, serum creatinine > 2.0mg%, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of > 1800/mm3 required for participation), or > 2 times the upper range of normal on liver function tests (SGOT, SGPT, total bilirubin)


Girls in Transition Study: Helping Girls Enter the Teenage Years

Summary: This is a pilot study of the Girls in Transition (GT) program, an intervention designed to promote resilience and reduce gender-related risk factors for depression. The goal of the study is to gather preliminary data on the effects of the GT program.
Inclusion criteria: inclusion criteria:

 Female

 Student in grades 6 through 8

 Student in participating school

Exclusion criteria: :

 Male

['Girls in Transition (GT) program', 'Waitlist Control']

Girls in Transition (GT) program
Waitlist Control


Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

Summary: The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy and metastases. Although serious complications are uncommon after treatment, there are well-documented adverse reactions secondary to the involvement of the salivary glands, such as dry mouth, pain in the parotid glands and dysphagia, even after administration of low doses of radioiodine. However, ocular complications of such treatment are scarcely reported in literature.~Among them the investigators can mention recurrent and chronic conjunctivitis, keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction have been reported as complications associated with the use of radioiodine, although studies are not available to assess its true incidence through the systematic evaluation of patients.~It can be seen in routine practice that these patients would normally be referred for ophthalmological examination only if a complaint, what happens in the process of OVL already installed after the use of high doses of radioiodine. With the early evaluation of these patients, the investigators focused on detecting the process of ongoing obstruction in order to study interventions that prevent its final installation.
Inclusion criteria: inclusion criteria:

 Thyroid carcinoma

 Previous thyroidectomy

Exclusion criteria: :

 Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic)

 Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL

 Lacrimal gland / ocular trauma

 Radiation therapy for other diseases or radiotherapy of head and neck

 Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation.


Keller Prehospital Ultrasound Study

Summary: The study is based on the premise that ultrasound is not commonly used in an ambulance. There are some departments that do deploy it into the field, but of those departments there is almost no data collected about its use. Currently Paramedics are not recognized by insurance companies as health care providers capable of performing ultrasound. If there were more data on the subject that may eventually change. We are hoping to prove that not only is ultrasound useful in an ambulance, but that paramedics are good at interpreting the results. We will save images, the paramedic's diagnosis and some basic information about the call. We will not save any protected health information (PHI) or any information linking the subject to the study. The data collected will be sent to a non-biased ultrasound reviewer to grade the images for the accuracy of diagnosis and the quality of the view obtained. This data will be used to formulate a report and statistics on paramedic's ability to perform ultrasound in the field.
Inclusion criteria: inclusion criteria:

 Activation of the Keller Fire Rescue Emergency Medical Service

 Meets disease process criteria described earlier

Exclusion criteria: :

 Does not meet the disease process criteria

['EFAST exam', 'Pelvic Ultrasound', 'Ultrasound Guided Vascular Access', 'Focused Ultrasound Scan', 'Cardiac Ultrasound']

EFAST exam
Pelvic Ultrasound
Ultrasound Guided Vascular Access
Focused Ultrasound Scan
Cardiac Ultrasound

['Ultrasonography', 'Multiple Trauma', 'Kidney Calculi', 'Aortic Aneurysm, Abdominal', 'Pregnancy', 'Catheterization, Venous']

Ultrasonography
Multiple Trauma
Kidney Calculi
Aortic Aneurysm
Abdominal
Pregnancy
Catheterization
Venous


CT Calcium Scoring in Suspected Stable Angina

Summary: Patients with stable chest pain presenting to general practitioners in UK are routinely referred to the chest pain clinics in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who have low likelihood of coronary artery disease (CAD). They recommend that patients with low likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value.~At our institution, we have been performing CTCS in this patient cohort since 2003. We plan to retrospectively review the usefulness in CTCS in patients with different likelihood for significant CAD, particularly in patients with absent calcium and compare with the traditional assessment. We also plan to follow-up these patients for any myocardial infarction and death from any cause.
Inclusion criteria: inclusion criteria:

 non-acute chest pain

 those who underwent CT calcium scoring

 availability of all relevant risk factor information

Exclusion criteria: :

 previous coronary disease i.e., myocardial infarction or revascularization


Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

Summary: The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.
Inclusion criteria: inclusion criteria:

 clinical diagnosis of polymyalgia rheumatica

Exclusion criteria: :

 decompensated diabetes mellitus

 decompensated arterial hypertension

['Betamethasone', 'isotonic sodium chloride solution (placebo)']


Curcumin in Treating Patients With Familial Adenomatous Polyposis

Summary: This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.
Inclusion criteria: inclusion criteria:

 Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir

 Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy

Exclusion criteria: :

 Female patients of childbearing age not on effective birth control

 Pregnant women

 White blood cell count (WBC) < 3500/ml

 Platelet count < 100,000/ml

 Blood urea nitrogen (BUN) > 25mg%

 Creatinine > 1.5mg%

 Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial

 Malignancy other than nonmelanoma skin cancer

 Active bacterial infection

 Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)

 Patients with a history of peptic ulcer disease

 Patients on warfarin or plavix

['Curcumin', 'Laboratory Biomarker Analysis', 'Placebo']

Curcumin
Laboratory Biomarker Analysis
Placebo


Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers

Summary: The purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers.~It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the VERSAJET™ device than with conventional surgical procedures.
Inclusion criteria: inclusion criteria:

 Patients who are at least 18 years of age.

 Males and females (provided they are not pregnant or, if of reproductive age, are using contraception).

 Patients with a venous stasis, diabetic foot or decubitus reference ulcer located between the tibia and foot.

 Patients undergoing surgical debridement of their reference ulcer in the operating room (OR).

 Patients undergoing their first surgical debridement of the reference ulcer.

 Patients suitable for debridement of their reference ulcer with both VERSAJET™ and conventional debridement techniques.

 Patients who are able to understand the evaluation and are willing and able to provide written consent to participate in the evaluation.

Exclusion criteria: :

 Patients with clinical signs of infection in the reference ulcer (e.g. purulence and / or odour).

 Patients with haemophilia

 Patients who have been treated with topical steroids, systemic immunosuppressants (including corticosteroids), anticoagulants or cytotoxic chemotherapy in the last 30 days, or who are anticipated to require such medications during the course of the study.

 Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be infected with Human Immunodeficiency Virus (HIV).

 Patients who suffer from acute or chronic bacterial, viral or fungal skin diseases that would interfere with wound healing.

 Patients with a known history of poor compliance with medical treatment.

 Patients who have participated in this evaluation previously or are currently participating in another clinical study.

['Versajet Hydrosurgery System', 'Conventional surgical debridement techniques']

['Diabetic Foot', 'Varicose Ulcer', 'Pressure Ulcer']

Diabetic Foot
Varicose Ulcer
Pressure Ulcer


Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women, Also Known as Women Weigh-in for Wellness

Summary: This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.
Inclusion criteria: inclusion criteria:

 women aged 40-69

 overweight or Class I & II obese (BMI 28 to 39.9)or BMI 40 to 45 with physician clearance

 state a commitment to losing weight

 speak and read English

 able to communicate over the telephone

 able to use a computer with minimal assistance and complete electronic forms and surveys

 have access to and are able to access the Internet

 commitment to access the website as required by the research intervention including weekly self-reporting of calories and fat grams, weekly self-reporting of physical activity, pedometer steps, and body weight, and weekly (or more often) participation in other website components as determined by group to which randomized and phase of intervention

 have or are willing to obtain an email account

 have access to a DVD player

 able to walk without an assistive device

 answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician to become more active

Exclusion criteria: :

 diagnosed with Type 1 diabetes

 diagnosed with Type 2 diabetes and require insulin

 ≥ 10% weight loss in last six months

 enrolled in a weight loss management program

 enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation

 taking medications that affect weight loss or weight gain

 other physical or medical restrictions that would preclude following the minimum recommendations for moderate physical activity and healthy eating.

['Experimental: Web-based only (WO) weight intervention', 'Experimental: WO plus peer-led discussion board (WD)', 'Experimental: WO & professional email counseling (WE)']


TT-CMV Observational Birth Cohort Study

Summary: The spread of viruses through transfusions is the cause of serious illness and death in recipients whose immune systems are unable to fight infection. Another group of patients whose immune systems are underdeveloped and can be affected by a particular virus known as cytomegalovirus (CMV) is low birthweight infants (LBWIs). CMV can be spread through the placenta, during the birth process, through breast milk, while in the hospital or while caring for someone carrying the virus as well as through a transfusion, known as transfusion-transmitted (TT-CMV).~The spread of TT-CMV in LBWIs can be curtailed by transfusing blood products that are CMV negative as well as to filter the white cells in blood that carry the virus (leukoreduction). The purpose of this study is to see if the use of these two strategies can lower the spread of CMV through a transfusion. How safe the blood actually is through leukoreduction is not known and CMV still occurs in LBWIs. It is not clear whether this approach is optimal or whether additional safety steps are needed to completely prevent TT-CMV. Specific actions that could tell us when virus has reached the blood product or breast milk is to test each of these to determine if virus slipped unnoticed and/or when the product was not thoroughly filtered.~In this study, the investigators believe that the use of both prevention strategies will result in a lower rate of TT-CMV, and that the cause of TT-CMV may be found in the presence of CMV at the DNA level or by unfiltered white cells that remain in the blood product. Thus, the most significant clinical question that remains to be addressed is whether this double strategy for transfusion safety actually provides a zero CMV-risk blood supply or whether further safety measures (DNA testing + 100% leukoreduction) must be used to protect this extremely vulnerable patient group from CMV infection. This birth cohort study will be done with 6 participating NICUs, and will study both CMV positive and negative mothers in order to estimate the rate and pathway of CMV transmission to the LBWI who receives a transfusion. Another study goal is to compare or link any CMV infection by either transfused units where the virus was undetected, or filter failure. If CMV disease occurs, the investigators will be able to describe the course and outcome in LBWIs who develop TT-CMV.
Inclusion criteria: inclusion criteria:

 All LBWIs whose weight is ≤ 1500 grams at birth

 LBWI is within first five days of life

Exclusion criteria: :

 LBWI not expected to live past first seven days of life

 LBWI has a severe congenital abnormality

 LBWI has received a RBC or platelet transfusion at another institution prior to transfer

 LBWI has received an in-utero transfusion

 LBWI is clinically suspected of having toxoplasmosis, rubella, herpes infection(s) at birth

 Refusal by the mother to grant consent for herself and/or refusal to grant consent for her LBWI

 If the mother of the child has previously participated in this study


Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Summary: This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
Inclusion criteria: inclusion criteria:

 Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis

 Current or historical human fecal elastase < 50µg/gstool

 Weight greater than 3.75 kg

 Age 1 month to 6 years

 Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months

 Clinically stable condition without evidence of acute respiratory disease or any other acute condition

Exclusion criteria: :

 Ileus or acute abdomen

 History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome

 History of distal ileal obstruction syndrome within 6 months of enrollment

 Use of an immunosuppressive drug

 Any type of malignancy involving the digestive tract in the last 5 years

 Known infection with HIV

['Cystic Fibrosis', 'Pancreatic Exocrine Insufficiency']

Cystic Fibrosis
Pancreatic Exocrine Insufficiency


Physical Therapy for Women With Obstetric Trauma and Anal Incontinence

Summary: Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigators need to know how well the muscles of a woman's pelvic floor function after a vaginal delivery and this requires measuring their strength during a pelvic exam. At present, there are no studies that have looked at whether the intervention of PT/BT improves a woman's anal incontinence quality of life after sustaining genital trauma during vaginal deliveries
Inclusion criteria: inclusion criteria:

 Primiparous women aged 18 years of older

 Vaginal delivery, vacuum-assisted-vaginal-delivery (VAVD), or forceps-assisted-vaginal-delivery (FAVD) of a neonate of gestational age:

 27 completed weeks

 Singleton or vaginal delivery of multiple gestation

 Able to read and speak the English language

Exclusion criteria: :

 Unable to comply with physical therapy or office visits

 Unreliable transportation

 Preexisting neurologic, musculoskeletal or neuromuscular disorder rendering them unable to perform physical therapy requirements

 Cesarean delivery

 History of prior surgery for anorectal incontinence (i.e. sphincteroplasty

['Physical Therapy (PT) and Behavioral Therapy (BT)']

['Sphincter Ani Incontinence', 'Obstetric Trauma']

Sphincter Ani Incontinence
Obstetric Trauma


An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension

Summary: Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
Inclusion criteria: inclusion criteria:

 1. 18 years of age.

 2. Patients with stage II systolic hypertension

 3. If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.

Exclusion criteria: :

 1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.

 2. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.

 3. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg).

 4. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.

 5. Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.

 7. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.

 8. Laboratory test values considered clinically significant by the investigator.

 9. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal.

 10. Pregnant or lactating females.

 11. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.

['Olmesartan medoxomil', 'Olmesartan medoxomil/hydrochlorothiazide', 'Hydrochlorothiazide']


CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)

Summary: The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.
Inclusion criteria: inclusion criteria:

 Patients with systemic Lupus erythematosus

Exclusion criteria: :

 Patients without systemic Lupus erythematosus


Bone Density and Serum Testosterone in Male Methadone Maintained Patients

Summary: This is a pilot study designed to answer the question  Do men who are receiving methadone maintenance therapy have lower spinal bone densities compared with age-matched controls who are not receiving methadone therapy?~The primary aim is to assess whether the mean or median spinal dual-ray energy x-ray absorptiometry (DEXA) scan results are different between these two groups of male patients. Primary measurements include: spinal bone densitometry by DEXA scan.~The secondary aim is to examine the role of sex steroids in men receiving methadone maintenance therapy and their association with spinal bone density and sexual dysfunction. Secondary measurements include: serum testosterone, estradiol, lutenizing hormone, albumin, sex hormone binding globulin and Vitamin D levels; age; Brief Sexual Function Inventory; Dietary, smoking/alcohol use and physical activity; Medical history, surgical and medication use; length of time using illicit opiates and time on methadone maintenance therapy.
Inclusion criteria: inclusion criteria:

 age 18 to 50

 methadone maintenance for at least 12 months (for cases)

 stable dose of methadone for 6 months (for cases)

 willing to participate in the study

 competency in English

 male

Exclusion criteria: :

 previous diagnosis of sexual dysfunction

 previous diagnosis of osteoporosis

 serum creatinine > 2 mg/dL

 chronic opiate use (for controls)

 congestive heart failure

 illicit drug use

['Opiate Dependence', 'Osteoporosis', 'Erectile Dysfunction', 'Hypogonadism']

Opiate Dependence
Osteoporosis
Erectile Dysfunction
Hypogonadism


Bladder Scan of Residual Urine With New Catheter

Summary: Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.
Inclusion criteria: inclusion criteria:

 Subject is a male IC user able to self-catheterise

 Subject has used hydrophilic-coated ICs for at least 1 month

 Subject is at least 18 years old.

 Subject has provided informed consent.

Exclusion criteria: :

 Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease).

 Subject has known abnormalities in the lower urinary tract.

['Test Catheter - SpeediCath Compact Male', 'SpeediCath']

Test Catheter - SpeediCath Compact Male
SpeediCath


Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

Summary: To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).
Inclusion criteria: inclusion criteria:

 Age ≥ 18 and <90 years old, male or female;

 CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);

 Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3;

 Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;

 Patients have never undergo surgery on the hematoma

 Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion criteria: :

 Allergic to the statin or its ingredients

 Cerebral herniation might occur at any time;

 Hematoma leads to herniation and warrants surgical operation.

 Hematoma caused by tumors, blood and other known comorbidities;

 Abnormal liver function

 Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study

 Patients have been on oral Statin treatment for a long time.

 Patients have been on oral Steroids treatment for a long time.

 Participate in clinical trials in the past four weeks;

 Pregnant or breastfeeding

 Failure of completing the trial by poor compliance;

 For any reason, the researchers believe that the case is not suitable for inclusion.


Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia

Summary: The purpose of this study is to verify the efficacy of speed-feedback therapy in improving the cognitive function of elderly people with dementia by a randomized controlled trial, and to demonstrate how that affects ADL and QOL.
Inclusion criteria: inclusion criteria:

 65 years of age or older

 Diagnosed with dementia by a physician

 Mini-Mental State Examination score of 23 points or less

 Capable of participating at least once a week for 6 weeks in succession

Exclusion criteria: :

 Management of a medical risk required

 Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis

 Never having been on a bicycle, and incapable of pedaling well

['Speed-feedback therapy system with a bicycle ergometer', 'Ergometer at conventional settings']


Ultrasound-Guided Needle Biopsy in the Diagnosis of Malignant Cervical Lymphadenopathies

Summary: The objective of the present study was to compare ultrasound (US) characteristics and ultrasound-guided core-needle biopsy (US-CNB) with US-guided fine-needle aspiration (US-FNA) in the assessment of different malignant cervical lymphadenopathies. Patients with malignant cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July to 2010 Dec were retrospectively reviewed. There are two major study groups according to the treatment status of the patient's population, including patients who had pathology proofed previous cancer and with clinically cervical lymphadenopathies after treatment. The second group included patients with cervical lymphaenopathies but without previous diagnosis of malignancy and treatment. The results of cytology, or pathology and time of needle biopsy to final diagnosis were traced and recorded. Morphologic US parameters and vascular features were thoroughly evaluated and compared in different disease.
Inclusion criteria: inclusion criteria:

 Patients with malignant cervical lymphadenopathie With US-FNA or US-CNB evaluation before

Exclusion criteria: :

 No ultrasound exam


Intervention and Outcomes in Duarte Galactosemia

Summary: The purpose of this study is to learn about Duarte galactosemia (DG). This study will examine the possible effects of Duarte galactosemia (DG) in children, and determine whether dietary exposure to milk in infancy or early childhood is associated with developmental outcomes of school-age children with Duarte galactosemia (DG).
Inclusion criteria: inclusion criteria:

 Healthy Children/Children with Duarte Galactosemia:

 Age between 6-12 years

Exclusion criteria: :

 Chronic illness

 Any condition unrelated to Duarte Galactosemia but known to cause developmental problems

 Children who did not have the current parent/guardian as the primary caregiver when the child was an infant


Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder

Summary: Children and adolescents with early-onset bipolar disorder (BD) are at high risk for intentionally hurting themselves. Although there are therapies in existence for these youths with BD, they do not address suicide prevention specifically. Mentalization-based therapy for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and adult population with borderline personality disorder. The investigators will modify the MBT-A treatment procedures for persons with BD who have had a recent period of suicidal ideation or behavior.
Inclusion criteria: inclusion criteria:

 Diagnosis of Bipolar Disorder I, Bipolar Disorder II, or Bipolar Disorder Not Otherwise Specified

 Living with or in close contact with at least one parent who is willing to participate

 Have had at least 1 week in the prior 3 months of significant suicidal ideation and/or at least one suicidal event in the 3 months prior to study intake.

 Willing to be treated pharmacologically by a psychiatrist in the UCLA Child and Adolescent Mood Disorders (CHAMP) clinic

Exclusion criteria: :

 Participants requiring immediate hospitalization

 Diagnosis of borderline personality disorder, schizophrenia, or schizoaffective disorder.

 Current substance dependence disorder

['Bipolar Disorder', 'Suicidal Ideation']


Upper Airway Microbial Development During the First Year of Life

Summary: This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first one to two years of life.
Inclusion criteria: inclusion criteria:

 Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent)

 Mother of child enrolled must have a physician diagnosis of asthma or being treated for asthma (for 140 subjects; 40 subjects will be recruited from mothers and fathers without atopy - asthma, eczema, seasonal allergies)

 Child must be enrolled during first week of life

 Signed informed consent from parent(s) or legal guardian(s)

Exclusion criteria: :

 Child has a history of wheezing or underlying lung disease

 Respiratory complications at birth (airway support higher then nasal cannula)

 Born earlier then 37 weeks gestation

 Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD)

 Underlying neuromuscular disease

 Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia

 Hydrocephalus

 History of seizures

 History of arrhythmia and baseline oxygenation level <90% on room air

 Infant is non-viable

 Severe gastroesophageal reflux

 Prior chest surgery or structural abnormalities of the lungs or chest wall

 Has a history of adverse reaction to chloral hydrate

 Ward of the state

 Any physical finding(s) that would compromise the safety of the subject or the quality of the study data as determined by the site investigator


Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases

Summary: OBJECTIVES: I. Determine whether there is prompt engraftment after autologous peripheral blood stem cell transplantation using filgrastim (G-CSF) mobilization in patients with life threatening autoimmune diseases.~II. Determine the kinetics of T- and B-cell immune reconstitution after a combination of timed plasmapheresis, high dose cyclophosphamide and total lymphoid irradiation, and posttransplant immunosuppression with cyclosporine in these patients.~III. Determine whether this treatment regimen beneficially influences the clinical course of these patients.
Inclusion criteria: Autoimmune thrombocytopenia purpura: platelet count less than 20,000/mm3 Adequate or increased marrow megakaryocytes Presence of detectable platelet associated immunoglobulins not due to alloreactive antibodies or posttransfusion purpura Prior response to immunosuppressive therapy Platelet count chronically less than 20,000/mm3 with petechial bleeding or less than 50,000/mm3 with other bleeding OR Any history of life threatening hemorrhage Refractory to conventional therapy for at least 21 days Splenectomy At least 1 additional immunosuppressive therapy applied after splenectomy OR Controlled on conventional therapy but at price of unacceptable toxicity: Serious steroid related toxicity Absolute neutrophil count less than 500/mm3 25% of time, pure red blood cell transfusion dependent or other toxicities (e.g., hemorrhagic cystitis) that are a consequence of chronic or cytotoxic therapy Unable to wean from chronic daily or intermittent cytotoxic therapy

 Autoimmune hemolytic anemia or pure red cell aplasia, AIHA: Hemolytic anemia Hemoglobin less than 10.0 g/dL without transfusion Hemolysis as evidenced by both: Sustained reticulocytosis (greater than 125,000/mm3) without evidence of active bleeding or increasing hemoglobin Laboratory evidence of hemolysis Positive direct antiglobulin test or equivalent immune adherence test No evidence for paroxysmal nocturnal hemoglobinuria Negative Ham's test and sucrose hemolysis. For PRCA: Anemia due to selective decrease in marrow erythroid precursors Hemoglobin less than 10.0 g/dL without transfusion Severe reticulocytopenia (less than 20,000/mm3 despite anemia) Severely decreased marrow erythroid precursors Positive marrow coculture with serum or cells or response to immunosuppression No evidence for PNH Negative Ham's test and sucrose hemolysis Severe disease: Chronic (i.e., greater than 1 year) Transfusion dependent or untransfused hemoglobin less than 8.0 g/dL Ferritin greater than 2,000 or evidence of organ dysfunction due to iron overload Refractory to conventional therapy after all 3 of the following: High dose steroids (at least 1 mg/kg) for at least 21 days Splenectomy (except cold reactive antibodies) 1 additional immunosuppressive therapy OR Controlled on conventional therapy but at price of unacceptable toxicity

 Rheumatoid arthritis: Morning stiffness for at least 6 weeks Arthritis of 3 or more joint areas Arthritis of hand joints Symmetric arthritis Rheumatoid nodules Serum rheumatoid factor Radiographic changes Active rheumatoid disease as evidenced by all of the following: Elevated Westergren erythrocyte sedimentation rate Minimum of 16 swollen or tender joints using the 28 joint count method Must be at high risk for developing deforming joint disease as defined by at least 2 of the following: High titer IgM-IgG rheumatoid factor Radiographic evidence of erosive arthritis developing within the first 24 months of clinical disease Functional class II or III Refractory to conventional therapy after 12 months of: Methotrexate used in combination with cyclosporine, hydroxychloroquine, or sulfasalazine OR Intramuscular gold therapy (total dose greater than 1.0 g and duration at least 6 months) OR Controlled on conventional therapy but at price of unacceptable toxicity

 Juvenile rheumatoid arthritis: Under 16 years of age at onset Arthritis in 1 or more joints as defined by swelling or effusion, or presence of 2 or more of the following: Limitation of range of motion Tenderness or pain on motion Increased heat Duration of disease 6 weeks or longer Onset type defined by type of disease in first 6 months: Polyarthritis (i.e., 5 or more inflamed joints) Oligoarthritis (i.e., less than 5 inflamed joints) Systemic (i.e., arthritis with characteristic fever) Exclusion of other forms of juvenile arthritis Active disease evidenced by 1 of the following: Minimum of 2 swollen or tender joints using the 71 joint count method Endocardial or myocardial disease, or serositis Anemia or thrombocytosis of chronic disease High risk for developing deforming joint disease or evidence of potential life threatening involvement for at least 1 internal organ system Radiographic evidence of erosive arthritis developing within first 24 months of clinical disease Functional class II or III Endocardial, myocardial, pericardial, and/or pleural disease Hemoglobin less than 10.0 g/dL or platelet count greater than 600,000/mm3 Refractory to conventional therapy after 12 months of methotrexate used in combination with hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine, or cyclophosphamide OR Controlled on conventional therapy but at price of unacceptable toxicity

 Systemic lupus erythematosus: Malar rash Discoid rash Photosensitivity Oral ulcers Arthritis Serositis Renal disorder Neurologic disorder Hematologic disorder Immunologic disorder Antinuclear antibody Must have at least 4 of 7 variables on the lupus activity scale measured Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Azathioprine Cyclophosphamide (greater than 500 mg/m2 monthly for 6 months) Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity

 Vasculitis Definitive diagnosis of 1 of the following forms: Churg-Strauss syndrome Giant cell arteritis Henoch-Schonlein purpura Hypersensitivity vasculitis Polyarteritis nodosa Takayasu arteritis Wegener's granulomatosis Evidence of active disease defined as reversible manifestations of the underlying inflammatory process Must have 1 or more of the following: Elevated Westergren erythrocyte sedimentation rate Elevated C reactive protein Decrease serum complement levels Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy (i.e., failed or relapsed within 6 months) after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Methotrexate Azathioprine Cyclophosphamide Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity

 Performance status: ECOG 0-1 ECOG 2 allowed provided symptoms directly related to autoimmune disease Hepatic: No history of severe, prior or ongoing chronic liver disease Bilirubin less than 2.0 mg/dL AST less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 2.5 mg/dL OR Creatinine no greater than 2 times normal baseline for age in pediatric patients Cardiovascular: No symptoms of cardiac disease No active ischemic heart disease Ejection fraction greater than 45% by MUGA No uncontrolled hypertension Pulmonary: FEV1/FVC at least 60% OR Resting PO2 at least 80 mm Hg DLCO greater than 50% predicted O2 saturations greater than 94% in children unable to perform PFTs Neurologic: No active or ongoing ischemic or degenerative CNS disease not attributable to underlying disease Other: Not pregnant No poorly controlled diabetes HIV negative
Exclusion criteria:

['anti-thymocyte globulin', 'cyclophosphamide', 'cyclosporine', 'filgrastim', 'methylprednisolone', 'prednisone', 'Autologous Peripheral Blood Stem Cell Transplantation']

['Purpura, Schoenlein-Henoch', 'Graft Versus Host Disease', 'Anemia, Hemolytic, Autoimmune', 'Rheumatoid Arthritis', 'Churg-Strauss Syndrome', 'Hypersensitivity Vasculitis', "Wegener's Granulomatosis", 'Systemic Lupus Erythematosus', 'Giant Cell Arteritis', 'Pure Red Cell Aplasia', 'Juvenile Rheumatoid Arthritis', 'Polyarteritis Nodosa', 'Autoimmune Thrombocytopenic Purpura', 'Takayasu Arteritis']

Purpura
Schoenlein-Henoch
Graft Versus Host Disease
Anemia
Hemolytic
Autoimmune
Rheumatoid Arthritis
Churg-Strauss Syndrome
Hypersensitivity Vasculitis
Wegener's Granulomatosis
Systemic Lupus Erythematosus
Giant Cell Arteritis
Pure Red Cell Aplasia
Juvenile Rheumatoid Arthritis
Polyarteritis Nodosa
Autoimmune Thrombocytopenic Purpura
Takayasu Arteritis


Delirium at the Intensive Care Unit - a Retrospective Cohort Study

Summary: This project seeks to describe the incidence of delirium in the Intensive Care Unit (ICU) and to identify risk and preventive factors associated with development of delirium.~Especially, the investigators want to investigate if an imitated natural light/dark cycle influences frequency of delirium.
Inclusion criteria: inclusion criteria:

 Patients >18 years of age admitted to the ICU at Køge Hospital in the study period

Exclusion criteria: :

 Richmond Agitation Sedation Score (RASS): -4 or -5 during the whole study period

 No CAM-ICU scores during the ICU stay

 Unable to communicate in Danish (aphasic, deaf, non-Danish speaking, severe brain damage)

 Severe dementia documented in electronic patient charts (OPUS)

 Patients not receiving active treatment (moribund patients)

['Delirium', 'Intensive Care Unit Syndrome']


Neurophysiology of Cough Reflex Hypersensitivity

Summary: Central sensitisation is an increase in the excitability of nerves within the central nervous system, which can lead to heightened sensitivity to certain stimuli. This process is involved in some chronic pain conditions e.g. migraines and non-cardiac chest pain. Recent work by our group suggests central sensitisation may be an important mechanism leading to chronic cough.~The main questions in this study include:~Can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications?~Can the investigators demonstrate exaggerated sensitisation in patients with chronic cough (indicating these patients are already centrally sensitised)?~In animal studies, acid infusion into the gullet (oesophagus) is able to induce central sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain on the front of the chest but this study did not test the the cough reflex. Using human participants, the investigators plan to test whether acid infusion into the oesophagus increases the sensitivity of the cough reflex in healthy volunteers and also patients complaining of chronic cough.
Inclusion criteria: inclusion criteria:

 Healthy volunteers inclusion:

 Over 18 years

 Measurable cough reflex sensitivity - required as is the primary end-point

 No current or past history of chronic cough or chronic respiratory disease

 Chronic Cough Patients inclusion:

 Over 18 years

 Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux

 Normal chest radiograph - primary respiratory cause for cough excluded

 Normal lung function - primary respiratory cause for cough excluded Measurable cough reflex sensitivity - required as primary end-point

Exclusion criteria: :

 Recent upper respiratory tract infection (<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles

 Pregnancy/breast-feeding - unknown effects of oesophageal acid infusion

 Current smokers or ex-smokers with < 6 month abstinence or history > 20 pack years - smoking can alter the sensitivity of the cough reflex

 Opiate or ACE inhibitor use or centrally acting medication - can alter the cough reflex sensitivity

 Symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity

 Significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy

['Hydrochloric acid (0.15 molar)', 'Saline']