TRIAD Burden of Illness Mucositis Study

Summary: Observational (non-drug) study to look at the risks and burden of mucositis (sores) involving the mouth, throat and intestines in patients receiving chemotherapy and radiation therapy treatment for various cancer types.
Inclusion criteria: inclusion criteria:

 18 years or older

 Ability to understand the protocol and willing to provide written informed consent

 Membership in one of the following sub-cohorts:

 Histologically proven oral cavity or oropharyngeal cancers planned to receive a full cycle of daily single fraction radiation therapy (with or without boost) or IMRT +/- chemotherapy.

 Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) +/- chemotherapy.

 Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFOX +/- Avastin or Erbitux.1 cycle defined as 2 doses of FOLFOX.

 Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFIRI +/- Avastin or Erbitux. 1 cycle defined as 2 doses of FOLFIRI.

 Adenocarcinoma of the breast planned to receive a minimum of 2 cycles of TAC.

 Histologically proven adenocarcinoma (any primary) planned to receive a minimum of 2 cycles of capecitabine.

 Adenocarcinoma of the breast planned to receive standard or dose-dense doxorubicin and cyclophosphamide (AC) followed by paclitaxel (T) (4 cycles AC followed by 2 cycles T).

 Stage 3A or 3B non-small cell lung cancers planned to receive daily single fraction radiation with or without boost (1 fraction daily for 5-6 weeks) +/- Carbo/Taxol.

 B-cell Non-Hodgkin's lymphoma (NHL) planned to receive at least 2 cycles of CHOP-14, CHOEP-14, CHOP-DI-14, EPOCH-14 or CHOP-21 +/- rituxan
Exclusion criteria:

['Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)']


Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)

Summary: The objective of this study was to evaluate the use of high frequency chest wall oscillation (HFCWO) early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).
Inclusion criteria: inclusion criteria:

 Age 18 years and older

 Admission to the inpatient medical service

 Physician-diagnosed asthma or asthma/COPD or COPD exacerbation.

 Evidence of airflow obstruction on spirometry

Exclusion criteria: :

 More than 24 hours since admission to the inpatient medical service

 Admission to an intensive care unit

 Hospital discharge planned within the next 24 hours

 Other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis)

 Chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest

 Chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest

 Physician declines to provide consent

 Patient unable (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent

 Previous participant in this study

 Corticosteroid therapy (prednisone >0 mg/d equivalent) for >1 week prior to admission

['High Frequency Chest Wall Oscillator']

['Asthma', 'Chronic Obstructive Pulmonary Disease (COPD)', 'Undifferentiated Asthma/COPD']


The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)

Summary: This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may also be enrolled).
Inclusion criteria: inclusion criteria:

 Adult male and female subjects (>= 18 to 75 years of age) with a diagnosis of moderate to severe plaque-type psoriasis for at least 6 months prior to study screening (subjects with concurrent psoriatic arthritis may also be enrolled).

 Subjects must be eligible for phototherapy or systemic therapy for their psoriasis and must have a Baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved at Baseline.

 Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.

 Subjects must also meet the tuberculosis (TB) eligibility assessment and screening criteria as follows: Have no history of latent or active TB prior to screening; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication.

 Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB.

 Specific parameters must also be met with regard to screening laboratory test results and liver enzymes in order to be eligible to participate in the study.

Exclusion criteria: :

 Subjects who have non-plaque forms of psoriasis, current drug-induced psoriasis, are pregnant, nursing, or planning pregnancy;

 Subjects previously treated with MTX or infliximab; subjects who are taking specific drugs within the specified time frame prior to Baseline as follows: any therapeutic agent targeted at reducing tumor necrosis factor (TNF) or any biologic, live virus or bacterial vaccinations within 3 months; any systemic medications or treatments that could affect psoriasis or PASI evaluations, or any systemic immunosuppressants or lithium within 4 weeks; any topical medications or treatments that could affect psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for psoriasis are shampoos (containing tar or salicylic acid only) and topical moisturizers. Subjects should not use these topical agents during the morning prior to a study visit. Non-medicated shampoos may be used on the morning of a visit.

 Subjects with poor health, including concomitant congestive heart failure (CHF); history of chronic or recurrent infectious disease, as specified; human immunodeficiency virus, hepatitis B, or hepatitis C; demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis; systemic lupus erythematosus; or who have had serious infections (eg, hepatitis, pneumonia, or pyelonephritis], or who have been hospitalized or received IV antibiotics, or who had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB), or a transplanted organ within specified time frames; or other conditions as specified in the protocol.

 Subjects who have used any investigational drugs within 4 weeks of Screening, who are participating in other clinical studies, staff or family members of study staff are excluded from participation in the study.


Tumor Markers in Lung Cancer: DCAMLK-1LK-1

Summary: DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung cancers.~The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking status.
Inclusion criteria: inclusion criteria:

 >45 years of age

Exclusion criteria: :

 Unable to provide informed consent

['Measure DCAM levels in blood', 'DCAM levels in blood']

Measure DCAM levels in blood
DCAM levels in blood


Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors

Summary: Most resectable tumors arising in the body or tail of the pancreas are malignancies or premalignancies which are surgically treated with distal pancreatectomy in combination with splenectomy. Retrieval of the lymph node tissue which lies along the splenic vessels is necessary to complete an oncologically sound operation. Two techniques for spleen preserving distal pancreatectomy have been described, but only a small number of lesions are amenable to spleen preserving pancreas surgery because these operation compromise oncologic principles. Removal of a normal spleen usually does not cause immediate consequences but can make patients vulnerable to life threatening infections. Asplenic patients must be vigilant for these infections and antibiotic prophylaxis is recommended anytime a fever occurs. Splenectomy results in measurable changes in the cellular components of the blood. If thrombocytosis occurs as a result of splenectomy, it requires life-long antiplatelet treatment.~Some childhood hematologic disorders such as hereditary spherocytosis are successfully treated with partial splenectomy. The post-surgical remnant spleen has been shown to be viable and functional. Both hematologic and immunologic function of the spleen seems to be preserved in most patients. Partial splenectomy has also been successful ly employed to treat benign and malignant lesions of the spleen. Unfortunately these indications for surgery are rare and so the experience with partial splenectomy is small.~To date, distal pancreatectomy with partial splenectomy has not been described in the medical literature. The investigators have devised a surgical procedure combining distal pancreatectomy with partial splenectomy, in principal allowing preservation of splenic function without compromise of oncologic principles. This procedure is possible now because of new technology which allows for near bloodless transection of solid organs. These instruments are routinely used in liver, kidney and pancreas surgery. There are scattered reports of successful use of these instruments in splenic transection, but there is no large experience to date.~The study intends to answer the question, is the proposed procedure, distal pancreatectomy and partial splenectomy, a viable alternative to the current standard of care, distal pancreatectomy with total splenectomy, for patients who will undergo surgical treatment of pancreas lesions arising in the body or tail of the pancreas?
Inclusion criteria: inclusion criteria:

 Patients with solid or cystic neoplasms of the pancreas who are being considered for distal pancreatectomy/splenectomy to be performed in either an open, laparoscopic, of da Vinci assisted fashion.

 No evidence of metastatic disease

 No evidence of local invasion into surrounding organs

 ECOG performance status <3

 Age 18 years or greater

 Participants will provide written informed consent to be part of the study

Exclusion criteria: :

 Age less than 18 years old

 Women who are pregnant

 Known hereditary bleeding disorder with history of post-operative hemorrhage

 Patients maintained on chronic anticoagulation (eg Coumadin therapy)

 Known hematogenous disorder

 Previous gastric fundoplication procedure or any procedure which interrupts the short gastric blood supply to the spleen

 Known primary or secondary malignancy of the spleen

 Pancreatic tumors which invade surrounding structures

 Prisoners

 Patients with impaired decision-making skills

['Distal pancreatectomy with partial splenectomy']


Maternal Microcirculation & SDF Imaging

Summary: This is a study of pregnant women undergoing a cesarean delivery. It will compare their microcirculation before and after the anesthetic. Microcirculation means blood flow to the extremely small blood vessels in the body. It will also look at the differences in microcirculation of participants who receive an infusion of phenylephrine compared to participants who don't. The investigators hypothesize that spinal anesthesia will reduce the vascular density and proportion of perfused vessels.
Inclusion criteria: inclusion criteria:

 American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)

 Singleton pregnancies

 36-42 weeks gestation

 Non-labouring

 Scheduled cesarean delivery

 English speaking

 Age 18-45 years

Exclusion criteria: :

 Cardiovascular disease

 Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia)

 Allergy to phenylephrine, or any other standardized medication

 Obesity (BMI > 35 kg/m2)

 Diabetes Mellitus type 1

 Smoker

 Coffee/Caffeine intake within 6 hours of SDF measurement

['Initial MicroScan® (Microvision Medical) SDF Measurement', 'Spinal Anesthesia- Bupivacaine', 'Comparative MicroScan® (Microvision Medical) SDF Measurement', 'Bolus Phenylephrine/Ephedrine Treatment', 'Phenylephrine Infusion']


Dental Safety Profile of High-Dose Radioiodine Therapy

Summary: We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer.
Inclusion criteria: inclusion criteria:

 histologically confirmed differentiated thyroid cancer

 status after total thyroidectomy

 status after subsequent high-dose radioiodine treatment

 regular follow-up by a board-certified dentist

 a minimum follow-up of 1 year after radioiodine therapy.

Exclusion criteria: :

 anaplastic thyroid cancer


Rituximab in the Treatment of Graves' Disease

Summary: Aim:~In a phase II pilot study encompassing 20 patients with Graves' disease to evaluate the effect of rituximab:~1. Biochemically as assessed by markers of disease activity ( free T4, free T3, TSH, TSH-receptor antibodies, anti-TPO)
Inclusion criteria: inclusion criteria:

 Graves´ disease

 Adequate anticonception in women.

Exclusion criteria: :

 Performance status >2

 Previous rituximab treatment

 Immunosuppressive treatment

 Serious concomitant disease

 Active infections

 Pregnancy / breast feeding.

['Methimazole', 'Rituximab', 'Immunization with various vaccines']

Methimazole
Rituximab
Immunization with various vaccines

['Graves´ Disease', 'Thyroid Associated Ophthalmopathy']

Graves´ Disease
Thyroid Associated Ophthalmopathy


Computer Tomography (CT) Trial of Acute Abdomen

Summary: The purpose of this study is to determine the impact of routinely performed early CT scanning in terms of diagnostic accuracy, patient management and cost-effectiveness compared to current imaging practice in patients suffering from acute abdomen.
Inclusion criteria: inclusion criteria:

 age > 18

 abdominal pain > 2h and < 7 days

Exclusion criteria: :

 pregnancy

 acute abdominal trauma

 allergy to iodinated contrast media

 severe renal insufficiency

 metformin medication combined with elevated plasma creatinin level

 lack of cooperation (if informed consent is not possible)

 abdominal pain combined with bleeding shock

['Abdominal contrast-enhanced CT scanning']


Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia

Summary: The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.
Inclusion criteria: inclusion criteria:

 Low to highly exuding chronic wound(wound history > 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer

 Male of female, 18 years and above

 Signed Informed Consent Form

Exclusion criteria: :

 Pregnancy or lactation

 Wound size not suitable for the wound dressing size

 Known allergy/hypersensitivity to any of the components in the dressing

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

Leg Ulcer
Diabetic Foot Ulcer
Pressure Ulcer


A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD

Summary: The purpose of this study is to evaluate the safety and effectiveness of infliximab (Remicade) in patients with Chronic Obstructive Pulmonary Disease (COPD). Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.
Inclusion criteria: inclusion criteria:

 Patients must have moderate or severe COPD

 Patients must have at least one episode of COPD-related symptoms (eg, cough, sputum production, shortness of breath) within 2 months prior to screening
Exclusion criteria: :

 Patients must not have asthma as main component of obstructive airway disease

 Patients must not have had a moderate or severe exacerbation of COPD within previous 1 month

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

Chronic Obstructive Pulmonary Disease
COPD


Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

Summary: The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.
Inclusion criteria: inclusion criteria:

 ASA physical status grade I and II infants (1-12month).

 undergoing elective cataract surgery in one eye under general anesthesia.

Exclusion criteria: :

 infection of the orbit,

 increased intraocular pressure(IOP),

 history of allergy to local anesthetics,

 history of previous eye surgery,

 cardiovascular or clotting disorders,

 full stomach,inner ear disorders or other conditions predisposing to vomiting

 airway abnormalities

 compromised sclera.

['SB dexmedetomidine bupivacaine block', 'intravenous dexmedetomidine']

SB dexmedetomidine bupivacaine block
intravenous dexmedetomidine

['Postoperative Pain', 'Postoperative Vomiting']

Postoperative Pain
Postoperative Vomiting


Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

Summary: OBJECTIVES:~I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome.~II. Compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.
Inclusion criteria: PROTOCOL ENTRY CRITERIA:

 --Disease Characteristics--

 Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure sensory neuropathy; No prior history of GBS

 Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable to walk 5 meters without assistance); Must not have improvement of one or more disability grades prior to randomization in this study

 No paresthesias, numbness, or weakness that began more than 14 days before randomization in this study

 No CNS involvement

 --Prior/Concurrent Therapy--

 Biologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg)

 Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma)

 Radiotherapy: Not specified

 Surgery: Not specified

 Other: No concurrent mechanical ventilation

 --Patient Characteristics--

 Age: Under 18 but with at least 3 months of independent walking

 Hematopoietic: Cerebrospinal fluid leukocyte count less than 50/mm3

 Hepatic: No liver failure

 Renal: No kidney failure

 Neurological: No other major neurologic diseases, other neuromuscular disorders, or cerebral palsy

 Other: HIV negative; No contraindications to plasmapheresis or IVIg; No severe uncontrolled infection; No known IgA hypersensitivity; No other preexisting disease that would interfere with assessment of disability grades; No other causes of acquired weakness (e.g., poliomyelitis, botulism, or other etiologies); No diabetes; Not pregnant
Exclusion criteria:


Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection

Summary: The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection.~Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.
Inclusion criteria: inclusion criteria:

 -

 Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either:

 Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of ≥1cm dilatation or ≥50% effacement), or

 Membrane rupture (standardized to duration of at least 4 hours prior to randomization).

Exclusion criteria: :

 Patient unwilling or unable to provide consent

 Multiple pregnancy

 Known azithromycin (or other macrolide) allergy

 Vaginal delivery

 Elective or scheduled cesarean prior to labor or membrane rupture.

 Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment.

 Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.

 Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient)

 Fetal demise or major congenital anomaly

 Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal

 Significant renal disease defined as serum creatinine known to be >2.0 mg/dl or on dialysis.

 Active congestive heart failure (EF<45%) or pulmonary edema

 Active diarrhea at time of delivery

 Any patient with significant electrolyte abnormalities such as hypokalemia or hypocalcemia

 Any patient with structural heart disease or arrhythmias, or taking any medications known to prolong the QT interval

 Patient currently being treated with efavirenz, nelfinavir or fluconazole

['Azithromycin and standard of care', 'Placebo and standard of care']

Azithromycin and standard of care
Placebo and standard of care

['Endometritis', 'Wound Infection', 'Abscess', 'Surgical Site Infection']

Endometritis
Wound Infection
Abscess
Surgical Site Infection


Continuous Adductor Canal Blocks Vs. Low Dose Femoral Nerve Blocks For Early Rehabilitation After Total Knee Arthroplasty

Summary: Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer adequate or equal analgesia and may promote better performance in early rehabilitation following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve Block (FNB). A common feature of these studies has been the use of moderate to high concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when injected by a large motor nerve will inevitably cause weakness. However, the practice at our institution has long been a continuous femoral nerve block (CFNB) with a lower concentration local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have performed several thousand CFNBs using this technique which has offered the advantage of minimal motor weakness and adequate analgesia.~The primary goal of this study is to determine if our established practice of using a low concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) - infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the 48-hour postoperative period.~Definitions of the location of the adductor canal are debated heavily in literature, but they seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3 of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will require placement of the continuous ACB no more distal than 20cm cephalad to the superior pole of the patella due to placement prior to surgery and the need to keep the dressing out of the operative field. The CACB catheter will also not be placed any more proximal than 20cm distal to the ASIS. In addition to other exclusion criteria, these measurements will create an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella distance (IPD) will be measured at the pre-operative interview on the day of surgery with a measuring tape. External palpable landmarks of the Anterior superior iliac spine and the superior pole of the patella will be used.~The primary outcome is based upon the ability to perform rehabilitation exercises postoperatively to the extent that criteria for discharge can be met. The primary outcome measured is the time at which a patient gains the ability to successfully perform a 75-feet unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary outcomes will be the number of days admitted prior to discharge, and average pain scores on DOS, Postoperative Day (POD) #1, and POD#2. The Day of discharge will also be used as a secondary outcome. Earlier discharge is becoming a goal of almost all healthcare systems to minimize costs.
Inclusion criteria: inclusion criteria:

 Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement

Exclusion criteria: :

 Body-Mass Index >40

 Iliac to Patella Distance (IPD) <40cm

 Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded)

['Continuous Femoral Nerve Block', 'Nerve Block, Continuous Adductor Canal', 'Continuous Sciatic Nerve Block', 'Bupivacaine']

Continuous Femoral Nerve Block
Nerve Block
Continuous Adductor Canal
Continuous Sciatic Nerve Block
Bupivacaine

['Pain, Postoperative', 'Total Knee Arthroplasty (TKA)']

Pain
Postoperative
Total Knee Arthroplasty (TKA)


Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation

Summary: Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy sham wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.
Inclusion criteria: inclusion criteria:

 aged 21 years or older

 CEAP Classification: Stage C4 (skin damage) and 5 (healed VLU) - leg ulcer healed within past month with intact epithelium

 history of healed VLU within past 2 years

 ankle brachial index (ABI) 0.80 - 1.3 mmHG, absence of peripheral arterial disease

 intact skin sensation

 intact thermal sensation

 agreement to ear compression during waking hours

 phone, email or mail accessible

 willingness to make 5 study visits including baseline

 able to understand protocol by passing test after watching DVD standardized instructions for low literacy

 able to perform required protocol activities

 ability to speak English

Exclusion criteria: :

 diagnosed arterial disease or ABI <0.80 or >1.3 mm Hg (blood flow to the skin is reduced in arterial disease and cooling could cause tissue ischemia)

 surgical procedures on leg in past 1 year (can affect venous circulation/cause edema)

 open leg/foot ulcers

 recent leg infection within past month (increased inflammation)

 impaired cognitive status (cannot perform procedures)

 chronic inflammatory and vascular conditions where blood flow of the skin may be impacted such as Lupus erythematosus, lymphedema, Raynaud's, rheumatoid arthritis, scleroderma, end stage renal disease, chronic obstructive pulmonary disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, or patients on chemotherapy

['Cryotherapy: Cooling gel wrap', 'Usual care']

Cryotherapy: Cooling gel wrap
Usual care

['Venous Disease', 'Venous Vascular Diseases and Syndromes', 'Venous Insufficiency', 'Venous Ulcers']

Venous Disease
Venous Vascular Diseases and Syndromes
Venous Insufficiency
Venous Ulcers


Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

Summary: The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
Inclusion criteria: inclusion criteria:

 the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30)

 an aliquot is available and suitable for testing, and

 the sample was randomly selected for inclusion.

Exclusion criteria: :

 sample integrity was compromised (eg, stored under unacceptable conditions)


CJD (Creutzfeldt-Jakob Disease) Quinacrine Study

Summary: The purpose of this clinical trial is to determine the effectiveness of the medication quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).
Inclusion criteria: inclusion criteria:

 Diagnosis of probable or definite sCJD: Definite--biopsy confirmed sCJD; Probable--a progressive dementia with either a typical EEG or a typical MRI consistent with sCJD, and at least two of the following clinical features: myoclonus, pyramidal or extrapyramidal signs, visual symptoms, cerebellar signs, akinetic mutism, other focal higher cortical neurologic signs (e.g. neglect, apraxia, aphasia)

 18 years of age or older

 Able to swallow

 Able to follow simple one-step commands

 Have had a brain MRI within 6 months and an EEG within 3 months ruling out other etiologies such as masses, strokes, or non-convulsive status epilepticus

 Consent to autopsy in the event of their death during or after the study

Exclusion criteria: :

 History of other significant or life-threatening disease, including: cancer; end-stage liver or renal disease; severe heart disease

 History of other disease requiring regular supportive care

 Liver disease

 Active alcoholism

 Bone marrow suppression

 Severe hypotension

 Severe psoriasis

 Poorly controlled diabetes

 Women who are pregnant or breast-feeding

 Men, or women of childbearing age, not practicing reliable contraception

 Serious allergies to quinacrine or other acridines

 Current or recent use of quinacrine (within 6 months)

 < 18 years of age

 Any other contraindication to taking quinacrine

 Genetic form of prion disease is identified prior to study enrollment

 Current use of anti-arrhythmics (at discretion of investigator)

 G6PD (Glucose 6-Phosphate Dehydrogenase) deficiency (at discretion of investigator)


An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)

Summary: This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.
Inclusion criteria: inclusion criteria:

 Men and women (not pregnant and not nursing)

 Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months

 Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)

 If taken, background medication must be stable

Exclusion criteria: :

 Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months

 Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2

['Inflammation', 'Systemic Lupus Erythematosus']

Inflammation
Systemic Lupus Erythematosus


A Retrospective Study on Hospitalized Patients With Community-acquired Pneumonia in China (CAP-China)

Summary: The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and healthcare-associated pneumonia (HCAP) in real life of China .
Inclusion criteria: inclusion criteria:

 Patients > or = 14 years of age

 Patient meets the criteria of community acquired pneumonia

 Patient meets the criteria of healthcare-associated pneumonia

Exclusion criteria: :

 Patients <14 years of age

 Patient meets the criteria of hospital acquired pneumonia

 Known active tuberculosis or current treatment for tuberculosis

 Non-infectious pulmonary diseases

 HIV positive


Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia

Summary: This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the length of stay of patients admitted to hospital with a diagnosis of pneumonia. The antimicrobial stewardship program will be implemented in several hospitals in Ontario, Canada. The program will identify patients with pneumonia, review their charts and make recommendations to their attending physicians about antibiotic management.
Inclusion criteria: inclusion criteria:

 Community-acquired pneumonia

 Immunocompetent

 Age > 18 years

Exclusion criteria: :

 Admitted to an intensive care unit or high intensity unit

 Requiring invasive or non-invasive ventilation

 Life expectancy less than 3 months

 Hospitalization within the previous 3 months for at least 48 consecutive hours

 Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count <=200, splenectomy or on cytotoxic chemotherapy

 Neutropenic [defined as a PMN count<=0.5x109 cells/L] from any cause

 Receiving immunosuppressants [defined as >=40 mg prednisone daily (or steroid equivalent) for >=2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection


Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment

Summary: The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.
Inclusion criteria: inclusion criteria:

 Stable congestive heart failure

 Impaired renal function

 Taking oral loop diuretic

Exclusion criteria: :

 Acutely decompensated (unstable) and end stage heart failure

 Diuretics other than loop diuretics

 Pregnant or nursing

 Inability to follow instructions

 Participation in another clinical trial within past 30 days

['Heart Failure, Congestive', 'Renal Insufficiency']

Heart Failure
Congestive
Renal Insufficiency


Monitoring the Efficacy of Anthelmintics for the Treatment of Soil Transmitted Helminths P2

Summary: Objectives:~The overall objective is to monitor efficacy of mebendazole (MBZ) against Soil-Transmitted Helminths (STH).~The primary objective is:~(1) to monitor the efficacy a single dose 500 mg of mebendazole (MBZ) against Soil-Transmitted Helminths (STH) infections by means of Faecal Egg Count Reduction (FECR) and Cure Rate (CR).~The secondary objectives are:~to assess the occurrence of Necator americanus and Ancylostoma duodenal.~to assess the occurrence of β-tubulin mutations related to resistance before and after drug administration.~to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.
Inclusion criteria:
Exclusion criteria: :

 Subjects who are unable to provide a stool sample at follow-up

 Subjects who are experiencing a severe concurrent medical condition

 Subjects with diarrhea at first sampling

['Ascaris Lumbricoides', 'Ascaris Suum', 'Trichuris Trichiura', 'Trichuris Vulpis', 'Ancylostoma Duodenal', 'Ancylostoma Caninum', 'Ancylostoma Ceylanicum', 'Necator Americanus']

Ascaris Lumbricoides
Ascaris Suum
Trichuris Trichiura
Trichuris Vulpis
Ancylostoma Duodenal
Ancylostoma Caninum
Ancylostoma Ceylanicum
Necator Americanus


Remission Induction and Sustenance in Graves' Disease 2

Summary: ATD therapy for Graves' disease is one of the commonly used options for therapy of the hyperthyroidism. The investigators study how to optimally keep patients in remission.
Inclusion criteria: inclusion criteria:

 Graves hyperthyroidism in remission after ATD

Exclusion criteria: :

 Age < 18, severe concomitant disease

:

 Age < 18, severe concomitant disease


Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)

Summary: This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).
Inclusion criteria: inclusion criteria:

 Presents to emergency department with documented history of CHF and symptomatic ADHF, will be treated for ADHF, and primary reason for admission to the hospital is ADHF

 Dyspnea at rest or with minimal exertion and must have moderate shortness of breath (SOB) in any of the first three Provocative Dyspnea Assessment positions

 Severe pulmonary congestion as evidenced by jugular venous distention or lower extremity/sacral edema or rales upon chest auscultation or chest x-ray.

 BNP > 400 or NT-pro BNP > 1500 drawn during Screening

 Systolic blood pressure >= 100 mmHg to < 180 mmHg at time of start of study drug

 Serum sodium value >= 115 mEq/L (115 mmol/L) and < 135 mEq/L (135 mmol/L) during Screening

Exclusion criteria: :

 Clinical evidence of volume depletion

 Active ongoing acute coronary syndrome or acute ST segment elevation myocardial infarction (or has experienced a myocardial infarction within 30 days of Screening)

 In cardiogenic shock

 Calculated creatinine clearance < 30 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) equation, has received intravenous (IV) contrast agent within 72 hours prior to randomization or is expected to receive IV contrast agent within the first 72 hours of study participation

 Ultrafiltration within the past 72 hours.

 Currently using or expected to use inotropic therapy

 Cardiac bypass grafts in the past 60 days

 Cerebrovascular accident in the past 30 days

 Uncontrolled brady- or ventricular tachyarrhythmias requiring emergent pacemaker placement or treatment

 Hemodynamically significant uncorrected primary cardiac valvular disease or hypertrophic cardiomyopathy

 Untreated severe hypothyroidism, hyperthyroidism or adrenal insufficiency based on medical history

 ALT or AST elevations > 5 times upper limit of normal

 Biliary liver cirrhosis, history or presence of severe hepatic encephalopathy, ascites, esophageal variceal bleeding within the past three months, severe portal hypertension or surgical portosystemic shunt.

 Received any organ transplant, clinical diagnosis of pneumonia, symptomatic hyponatremia requiring urgent intervention or any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety

 Pregnant or lactating

 Currently using vasopressin, oxytocin or desmopressin

['Hyponatremia', 'Acute Decompensated Heart Failure']

Hyponatremia
Acute Decompensated Heart Failure


Hospital Based Incidence of Group A Streptococcal Disease in Fiji

Summary: The purpose of this ongoing study (Part II) is to estimate the incidence of acute rheumatic fever, rheumatic heart disease, acute post-streptococcal glomerulonephritis (kidney disease), and invasive group A streptococcal (GAS) disease (strep infection) in Fiji to help develop better treatments and vaccines. Group A streptococcal disease is caused by the bacterium group A streptococcus. It is commonly found in the nose and throat of normal healthy adults and children, and can cause illness. The bacterium is spread by close contact with patients or carriers, through things like coughing, sneezing, kissing, or sharing a drink and can cause a wide variety of illnesses. These illnesses may be a sore throat, skin sores, and less commonly acute rheumatic fever or kidney disease. Participants of all ages will be recruited through the Colonial War Memorial and Lautoka Hospital. A blood sample will be collected from each study participant. Subject participation should be less than one day.
Inclusion criteria: inclusion criteria:

 Informed consent will be obtained from all study participants. Children between 0 -17 years of age will be enrolled in the APSGN study. Children between 3-17 years of age and adults between 18-40 years will be enrolled in the ARF study. Children and adults of all ages will be enrolled in the RHD and invasive GAS studies.

Exclusion criteria: :

 None


Bindex Ultrasonometer for Osteoporosis Diagnostics

Summary: Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and do not receive treatment for their condition.~This research plan describes a study for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.~For validation of the technique in US population, our study plan is presented for determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex, lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140 men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury, MN.~To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD;~To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis is 20%) post-menopausal females (50-90 years);~To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;~To investigate correlation between lumbar spine or proximal femur BMD and Density Index in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or low bone mass. Determine diagnostic thresholds for DI in men.
Inclusion criteria: inclusion criteria:

 Postmenopausal women and men referred for bone density examination.

Exclusion criteria: :

 Patients unable to sign consent for participation.


The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women

Summary: To examine the change in sleep patterns and mood symptoms in response to eszopiclone (Lunesta) using a double-blind placebo-controlled cross-over study design in perimenopausal and postmenopausal women who experience insomnia, mild depression and/or anxiety.
Inclusion criteria: inclusion criteria:

 Women 40+ years old.

 Subject must have any of the following perimenopausal or postmenopausal signs and symptoms as defined by the Stages of Reproductive Aging Workshop (STRAW):

 Early Menopausal Transition (Stage -2): Variable cycle length >7 days different from normal.

 Late Menopausal Transition (Stage -1) : > 2 skipped cycles and an interval of amenorrhea > 60 days.

 Post Menopause (Stage +1): Amenorrhea for at least 12 months.

 Surgical Post Menopause

 Hysterectomized women with one or both ovaries preserved will be eligible if FSH levels > 20 IU/L.

 If on hormonal therapy, history of menstrual-cycle abnormalities consistent with any of 2a-2e above indicating peri-/postmenopausal status prior to initiation of hormonal therapy.

 One or both the following insomnia symptoms for ³ 3 nights per week for at least one month prior to study enrollment:

 Difficulty initiating sleep (³ 30 minutes)

 Difficulty maintaining sleep (wake time after sleep onset ³ 30 minutes)

 Daytime function or well-being is impaired as a result of insomnia.

 Mild depression and/or anxiety at screening visit defined as:

 Mild Depressive symptoms defined by Montgomery-Åsberg Depression Rating Scale-MADRS (MADRS) ³ 10 administered at screening visit, or

 Mild Anxiety symptoms defined by Beck Anxiety Inventory (BAI) ³ 10 administered at screening visit.

 May have (but not required) hot flushes

 May have (but not required) developed insomnia after discontinuation of hormonal therapy.

 If subject is on an antidepressant, they must have stable doses for at least 2 months.

 If subject is on hormonal therapy, dose must be stable for at least 2 months.

 General Good Health

Exclusion criteria: :

 According to M.I.N.I (Mini International Neuropsychiatric Interview), subject meets current or past criteria for past 3 months:

 Major Depression

 Dysthymia

 Panic disorder

 PTSD (Post-Traumatic Stress Disorder)

 According to M.I.N.I, subject has no evidence of current suicidal ideation, homicidal ideation, or psychotic symptoms at screening visit.

 Suicide attempt in the past 5 years.

 According to M.I.N.I, subject meets criteria for substance use disorder diagnosis within the past 5 years.

 Subject has current or recent use (in the past month and used > 25% of time) of hypnotic agents.

 Subject is on an antidepressant or hormone therapy in past 2 months. (Unless they are taking currently and have had a stable dose for ≥ 2 months).

 Subject has:

 Unstable medical abnormality

 Unstable chronic disease.

 History of significant cardiac, renal, or hepatic disease, or seizure disorder.

 Regular use of any disallowed medication (Including; Clarithromycin, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Olanzapine, Rifampin, Ritonavir, Troleandomycin) currently or in the past month.

 Subject has a disorder or history of a condition (e.g., mal-absorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.

 Subject has a been previously diagnosed sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS), or has any condition that may affect sleep (e.g., chronic pain, urinary incontinence, etc.).

 Subject reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day during the past month.

 Currently pregnant or breastfeeding

 Subject is a rotating or third/night shift worker.

 Subject often travels across multiple time zones.

 Subject is currently enrolled in another clinical trial, subject has participated in any investigational drug study within 30 days prior to screening, or plans to participate in another investigational drug study during participation in this study.


Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket

Summary: Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.
Inclusion criteria: inclusion criteria:

 - Trauma patients ≥ 18 years of all severity stages including poly traumatized patients admissioned through the emergency room

Exclusion criteria: :

 Patients < 18 years

 Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission

['ReadyHeat® blanket', 'Cotton wool blanket']


Donepezil in Preventing Delirium in Hospitalized Elderly

Summary: The purpose of this study is to explore the efficacy of a perioperative daily dose of Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.
Inclusion criteria: inclusion criteria:

 Community-dwelling individuals aged 65 or older

 Admitted to Methodist Hospital for surgical repair of hip fracture

 No evidence of delirium at admission to hospital

 MMSE total score below 24 points after adjustment for education and age

 Consent to participate in the study

Exclusion criteria: :

 Severely demented as defined by MMSE score below 10

 Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months

 Multiple trauma or pathological fractures

 Aphasic, legally blind, or deaf

 Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery

 Allergy to Donepezil


PTH - Preemptive Treatment for Herpesviridae

Summary: The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of ventilator-free days at Day 60.
Inclusion criteria: inclusion criteria:

 mechanical ventilation > 96 hrs and expected duration of mechanical ventilation of at least 2 days

 positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR

 age > 18 years

 informed consent

 negative pregnancy test

Exclusion criteria: :

 < 18 years

 Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV

 Had received antiviral agent active against HSV/CMV during the previous month

 Hypersensitivity to aciclovir/ganciclovir

 Pregnancy

 Breast feeding

 Bone marrow failure

 Solid organ recipients

 Bone marrow recipients

 HIV positive patients

 Receiving immunosuppressive agents

 SAPS II > 75

 Withdrawing/withholding

 Neutropenia (< 500 mm3)

 Thrombocytopenia (< 25 G/L)

 ICU readmission


The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands

Summary: The study project can be divided into two parts: (1) health screening for the community and (2) clinical diagnosis and treatment for patients at National Referral Hospital (NRH) in Solomon islands. The health screening includes a questionnaire, stool parasitic screening and blood laboratory tests. A total of 800 subjects will participate in this study. The collected samples are venous blood (20 ml/per subject) and stool in order to conduct the related tests mentioned above.~As for the collection of target patients, KMUH will cooperate with NRH to collect two kinds of blood samples: the blood samples of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial, and Leptospiral infections. The expected received cases are 600 each year. The venous blood samples (20 ml/per subject) will be used to conduct related tests mentioned above. At the same time, the subjects will also have to fill out a related questionnaire which includes height, weight, waist line, heath behavior and habit, and past history, etc.
Inclusion criteria: inclusion criteria:

 For community participants: Health volunteers who are willing to join this study (including the stool and blood testing) after explanation and sign the informed consents.

 For hospital cases: The patients ,who were suspicious of malaria, leptospirosis, Alpha-viral(Chikungunya virus, Ross river virus), and flavivirus infections (dengue fever, Japanese encephalitis..ect) by the attending physicians, will be informed about this study by drawing blood samples if they agree to participate.

Exclusion criteria: :

 The participants whose stool or blood samples were in-adequate or missing will be excluded from this study.

 The participants whose documented personal information is fake or cannot be identifiable will also be excluded from this study.

['Flavivirus Infection', 'Alphavirus Infections', 'Malaria', 'Parasitic Disease', 'Leptospirosis', 'Hypertension', 'Metabolic Syndromes']

Flavivirus Infection
Alphavirus Infections
Malaria
Parasitic Disease
Leptospirosis
Hypertension
Metabolic Syndromes


Blood Collection From Healthy Volunteers and Patients for the Production of Clinical Grade Induced Pluripotent Stem Cell (iPSC) Products

Summary: Background:~- Pluripotent stem cells are cells that can be converted to any type of cell (muscle, nerve, liver, etc.). Researchers are collecting blood samples to develop way to make a special cell product called induced pluripotent stem cells (iPSCs). iPSCs may be used to repair or replace organs and tissues, produce blood and immune cells for transfusion, or correct inherited immune and blood diseases. iPSCs can be made from many kinds samples, such as skin, blood, or hair. This is different from embryonic stem cells, which can only be derived from embryos.~Objectives:~- To develop new methods to make iPSCs; to identify better ways to collect, produce, and grow them; and to make an iPSC bank.~Eligibility:~- Healthy adults and adults already in a treatment protocol who have a medical condition that could be treated with iPSCs.~Design:~All participants will be screened with questionnaire, physical exam, and blood and HIV tests.~All participants:~Will donate 4 tablespoons of blood. It will be taken by needle from a vein in their arm.~Participants already in another protocol:~Will have their blood collected, separated in a lab, and iPSCs grown in large numbers. Some may have their sample given back to them as a treatment.~Samples will be kept in the study up to 5 years or until a participant withdraws from the study or becomes ineligible to participate, or the study is closed. If participants have not withdrawn their consent, they may be contacted in the future to donate again.
Inclusion criteria: inclusion criteria RELATED OR THIRD PARTY DONORS (ALLOGENEIC CELLS, INCLUDING RESEARCH DONORS) AND AUTOLOGOUS DONORS

 Subjects who meet ALL of the following criteria will be considered for enrollment into this study:

 Be greater than or equal to 18 years of age, as of the date of enrollment. There is no upper age limit for donor enrollment.

 Able to provide informed consent.

 Meets the donation requirements established by AABB and FDA for allogeneic or autologous use with the exception of hemoglobin/hematocrit.

 SUBJECT
Exclusion criteria:  ALLOGENEIC DONORS

 Subjects who meet ANY of the following criteria will be excluded from participation in this study as a third party donor or research volunteer:

 Medical history that includes any of the following, as per AABB or FDA requirements for allogeneic use:

 Thrombocytopenia or other blood dyscrasias

 Bleeding diathesis

 Antibiotic use within the prior 48 hours

 History of cancer

 History of exposure to transfusion transmitted diseases including HIV and hepatitis B and C as defined by the Standards for Blood Banking and Transfusion Services, AABB.

 Travel to an area where malaria is endemic as defined by the CDC (www.cdc.gov/travel).

 At risk for the possible transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) as described in the FDA Guidance for Industry, January 9, 2002, Revised Preventive Measures to Reduce the Possible Risk of Transfusion of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

 Febr le (temperature >38 (Infinite)C)

 Hemoglobin level

 African American women <11.5 grams/dL

 Other women <12.0 grams/dL

 Men <12.5 grams/dL

 HCT

 African American women <34%

 Other women <36%

 Men <38%

 Platelets <150 times 103/microL

 Absolute neutrophil count <1.0 times 103/microL

 Positive tests for blood borne pathogens (as required by the Standards for Blood Banks and Transfusion Services, AABB. The currently required tests include anti-HIV1/2, anti-HCV, anti-HBc, Anti-HTLV I/II, anti-T. Cruzi, HBsAg, syphilis, and molecular testing for West Nile virus, HCV, HBV, and HIV-1).

 SUBJECT


Preventive Measures for Childhood-Onset Obsessive-Compulsive Disorder and Tic Disorders (PANDAS Subgroup)

Summary: A subgroup of patients with childhood-onset obsessive-compulsive disorder (OCD) and/or tic disorders has been identified who share a common clinical course characterized by dramatic onset and symptom exacerbations following group A beta-hemolytic streptococcal (GABHS) infections. This subgroup is designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections). There are five clinical characteristics that define the PANDAS subgroup: presence of OCD and/or tic disorder; prepubertal symptom onset; sudden onset or abrupt exacerbations (relapsing-remitting course); association with neurological abnormalities (presence of adventitious movements or motoric hyperactivity during exacerbations); and temporal association between symptom exacerbations and GABHS infections. In this subgroup, periodic exacerbations appear to be triggered by GABHS infections in a manner similar to that of Sydenham's chorea, the neurological variant of rheumatic fever.~Rheumatic fever is a disorder with a presumed post-streptococcal autoimmune etiology. The streptococcal pathogenesis of rheumatic fever is supported by studies that have demonstrated the effectiveness of penicillin prophylaxis in preventing recurrences of this illness. A trial of penicillin prophylaxis in the PANDAS subgroup demonstrated that penicillin was not superior to placebo as prophylaxis against GABHS infections in these children, but this outcome was felt to be secondary to non-compliance with treatment, and there was no decrease in the number of neuropsychiatric symptom exacerbations in this group. In a study comparing azithromycin and penicillin, both drugs were completely effective in preventing streptococcal infections - there were no documented titer elevations during the year-long study period for children taking either penicillin or azithromycin. Comparable reductions in the severity of tics and obsessive-compulsive symptoms were also observed. Thus, penicillin was not performing as an active placebo as originally postulated, but rather provided effective prophylaxis against Group A beta-hemolytic streptococcal. Both azithromycin and penicillin appear to be effective in eliminating GABHS infections, and reducing neuropsychiatric symptom severity; thus, between-group differences are negligible. Since increasing the n to demonstrate superiority of one prophylactic agent over another would be impractical, we have amended the study design to address two issues:~To determine if antibiotics prophylaxis against GABHS infections is superior to placebo in prolonging periods of remission among children in the PANDAS subgroup.~To determine if antibiotics prophylaxis against GABHS infections is superior to placebo in improving overall symptom severity for obsessive-compulsive symptoms and tics among children in the PANDAS subgroup.~Because penicillin has a narrower therapeutic index and is less expensive than azithromycin, it is the preferable prophylactic agent. Further, penicillin (250 mg orally twice a day) has a long history of providing safe and effective prophylaxis for rheumatic fever and is the first line oral therapy recommended by the American Heart Association. Thus, penicillin has been chosen as the prophylactic antibiotic in the present study. Blister packs are used to increase compliance and to allow for easier documentation of missed doses.
Inclusion criteria: inclusion criteria:

 Ages 4 - 18 years

 Fulfill criteria for membership in the PANDAS subgroup:

 Presence of OCD and/or tic disorder

 Prepubertal symptom onset

 Abrupt onset and episodic (relapsing-remitting) symptom course

 Association between symptom exacerbations and GABHS infections

 Presence of choreiform movements or other neurological abnormalities during symptom exacerbations.

 Because time to relapse is one of the primary outcome variables, children will not be eligible for randomization until their symptoms are in (at least partial) remission. At the time of randomization, symptom severity scores should be less than 50% of the child's previous maximum score on both the CY-BOCS and YGTSS, and no higher than a total score of 20 on the CY-BOCS or 30 on the YGTSS.

Exclusion criteria: :

 Personal history of penicillin allergy

 History of rheumatic fever, including Sydenham's chorea

 Diagnosis of autism, schizophrenia or other psychotic disorder

 Chronic illnesses, particularly neurologic and immunologic disorders

['Mental Disorder Diagnosed in Childhood', 'Obsessive Compulsive Disorder', 'Streptococcal Infection', 'Tic Disorder']

Mental Disorder Diagnosed in Childhood
Obsessive Compulsive Disorder
Streptococcal Infection
Tic Disorder


Robot-Assisted Motivating Rehabilitation

Summary: The purpose of the study is to examine how a novel robot technology designed for eventual use as a home therapy can improve arm function after stroke.
Inclusion criteria: inclusion criteria:

 Subjects will be included in the study on the basis of the following criteria:

 They must be at least six months post-stroke.

 18 years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert).

 They have voluntary control with a low to medium range of motion function (UE-FT<5) and a muscle tone.

 They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes.

 They report no excessive pain the impaired arm.

 If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel.

 They must not be participating in any experimental rehabilitation or drug therapies.

 If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment.

 They must have driven prior to stroke.

 They are not clinically depressed (as measured by the Geriatric Depression Scale (GDS) short form (Sheikh and Yesavage, 1986).

Exclusion criteria: :

 Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.

 Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function.

 Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.

['TheraDrive Assistive Device', 'Rote Therapy versus Fun Therapy']

TheraDrive Assistive Device
Rote Therapy versus Fun Therapy


Treating Alcohol Withdrawal With Oral Baclofen

Summary: The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy will experience fewer complications of AWS (as measured by use of additional sedatives, restraints, and/or intensive care unit [ICU] admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy.
Inclusion criteria: inclusion criteria:

 Meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) criteria for alcohol withdrawal syndrome (AWS).

 Be an inpatient at St. Mary's Medical Center (SMMC) or Miller Dwan Medical Center (MDMC) at time of study enrollment.

 Have an alcohol withdrawal score as measured by standard SMMC or MDMC inpatient protocol sufficient to trigger the use of benzodiazepine withdrawal therapy.

 Agree to abstain for alcohol for duration of study.

 Be able to provide informed consent.

Exclusion criteria: :

 The patient must not have any other active drug dependence in addition to alcohol.

 Be unwilling or unable to forgo alcohol for the duration of the study.

 Be using baclofen at the time of study enrollment.

 Be using benzodiazepines for any reason other than acute alcohol withdrawal syndrome at time of study enrollment.

 have known baclofen or benzodiazepine sensitivity.

 Be unable to take oral (PO) meds.

 Be unable to complete one of two consenting procedures.

 Be pregnant or breastfeeding.

 Have a serum creatine level > 2.0.

 Have a history of non alcoholic withdrawal seizures.


Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder

Summary: Objective: Although atypical antipsychotic drugs (AAPDs) have been found effective in the augmentation of serotonin reuptake inhibitors (SRIs) for treatment-resistant obsessive-compulsive disorder (OCD) in short terms trials, there are few data on the effectiveness and safety of these agents in clinical settings over the long term.~Method: Subjects (n=46) who responded to selective SRIs (SSRIs) in an initial 12-week trial were continued on SRI-monotherapy plus cognitive-behavioral therapy (CBT) for one year. Subjects (n=44) who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such as risperidone and were consecutively treated using SSRI+AAPD combined with CBT for a year.
Inclusion criteria: inclusion criteria:

 Male or female, 18 years of age or over

 Patients were diagnosed as having obsessive-compulsive disorder by the Structured Clinical Interview for DSM-IV Patient version (SCID-P)

 They received standardized treatment for at least 1 year at the OCD clinic in our university hospital.

 Each subject gave written informed consent to take part after receiving a complete description of this study.

 All subjects were free of medical illness based on results of physical examination and screening tests of blood and urine, and no subjects received any lipid lowering or hypoglycemic agent during the 1-year study period.

Exclusion criteria: :

 Current clinically significant medical conditions such as diabetes

['atypical antipsychotic drug', 'exposure response prevention']

atypical antipsychotic drug
exposure response prevention


Collection of Blood Samples From HIV Infected People

Summary: The purpose of this study is to collect blood samples from HIV infected individuals for use in future genetic studies.
Inclusion criteria: inclusion criteria:

 Presently participating, previously participated in, or has given informed consent for participation in a qualifying CPCRA clinical trial

 Signed informed consent
Exclusion criteria:


Methylphenidate in ADHD With Trichotillomania

Summary: This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and trichotillomania.~Trichotillomania is an impulse control disorder. There is growing evidences of the involvement of dopaminergic neurotransmission in the pathophysiology of trichotillomania. Reported increase in the prevalence of ADHD among patients with impulse control disorders, such as pathological gambling as well as trichotillomania, may result from the overlapping pathophisiological background. It is hypothesized that in cases of ADHD comorbid with trichotillomania methtylphenidate treatment will exhibit beneficial effects in both the ADHD and the hair pulling.
Inclusion criteria: inclusion criteria:

 DSM-IV Diagnosis of trichotillomania

 DSM-IV diagnosis of ADHD

 Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to entering the study.

Exclusion criteria: :

 History of moderate or severe adverse event, related to MPH

 History of any psychotic disorder

 Current drug abuse, acute psychotic or affective disorder


Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

Summary: The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.
Inclusion criteria: inclusion criteria:

 Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion criteria: :

 Prior Human Papillomavirus (HPV) vaccination

 Prior abnormal paps

 History of genital warts

['V501', 'Comparator: Placebo', 'Human Papillomavirus (HPV) 16 Monovalent']


REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study

Summary: Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006.~ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at >10mg/day is limited.~For this reason, this study was designed as a multicenter open-label uncontrolled study.~This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent Off/On, Modified Hoehn & Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.
Inclusion criteria: inclusion criteria:

 Subjects eligible for enrollment in the study must meet all of the following criteria. Note that both inpatients and outpatients are eligible.

 Patients with a diagnosis of PD (including juvenile parkinsonism) with Modified Hoehn & Yahr Stages I to IV.

 Patients who have been receiving another dopamine agonist for at least 4 weeks prior to the start of the screening phase and are expected to benefit from conversion to ROP.

 Age: 20 years (at the time of written informed consent).

 Informed consent: Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own).

 Gender: Male or female

 Females of childbearing potential are eligible for enrollment in the study, only if the subject has a negative pregnancy test at the start of the screening phase and agrees to conduct pregnancy testing at the protocol-specified visits during the study and use one of the following acceptable methods of contraceptions properly and accurately:

 Abstinence

 Oral contraceptive, either combined or progestogen alone

 Injectable progestogen

 Implants of levonorgestrel

 Estrogenic vaginal ring (Caution: This should be used cautiously, because the blood concentration of the study drug may be increased.)

 Percutaneous contraceptive patches

 Intrauterine device (IUD) or intrauterine system (IUS)

 Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject)

 Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)

Exclusion criteria: :

 Subjects meeting any of the following criteria must not be enrolled in the study:

 Patients who present with any serious medical condition other than PD (e.g., cardiac, hepatic or renal disorder or hematopoietic disorder).

 Serious is defined as Grade 3 as a rule according to the Classification of the Severity of Adverse Experiences.

 Patients with postural hypotension with any subjective symptoms (e.g., dizziness and syncope).

 Patients who have had any serious psychiatric symptoms (e.g., confusion, hallucination, delusion, abnormal behavior) (including symptoms caused by anti-PD drugs) within 6 months (26 weeks) prior to written informed consent.

 Patients who have initiated any of the following drugs within 4 weeks of the start of the screening phase and have the dosing regimen of the drug changed within 4 weeks of the start of the screening phase.

 L-dopa (+DCI) (NOTE: This does not apply to the monotherapy group.)

 Anticholinergic agents: trihexyphenidyl hydrochloride, piroheptine hydrochloride, mazaticol hydrochloride, metixene hydrochloride, biperiden, profenamine

 amantadine hydrochloride

 droxidopa

 citicoline

 selegiline hydrochloride

 entacapone

 zonisamide

 Patients with severe dementia with a Japanese UPDRS Part I (mentation, behavior, and mood) score of 3 or 4.

 Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study period or within 30 days after the last dose of the study drug.

 Patients with a history of drug allergy to any ingredients of ROP tablets.

 Patients who have received surgical treatment for PD in the past (e.g., pallidectomy, deep brain stimulation).

 Patients who have been treated with any other investigational product within 12 weeks prior to the start of the screening phase.

 Patients who, in the judgement of the investigator (or sub-investigator), have evidence of alcohol or drug abuse.

 Others whom the investigator (or sub-investigator) considers ineligible for the study.

['Parkinson Disease', "Parkinson's Disease"]


Study on the Difference of Axilo-rectal Temperature in Appendicitis

Summary: The investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit.
Inclusion criteria: inclusion criteria:

 Patients with acute appendicitis

 Patients with acute gastroenteritis

 Patients older than 15 years of age

Exclusion criteria: :

 Other acute abdominal diseases

['Observation and measurement of axilo-rectal temperature']


To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early

Summary: Chemotherapy lowers the white blood cell count or weakens the immune system for a long time. This puts the patients at a high risk of getting a serious fungal infection of the internal organs or blood. One of these infections is caused by a mold called Aspergillus and can be life threatening. Usually doctors give preventive antifungal therapy to try to lower the risk of this infection. Despite this, patients are still at risk of getting fungal infection. This study is thus designed to test Galactomannan - a component of cell wall of Aspergillus and hence detect and treat fungal infection early.
Inclusion criteria: inclusion criteria:

 Patients with newly diagnosed acute leukemia or high risk myelodysplastic syndrome (MDS) receiving induction chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days

 Patients with relapsed acute leukemia or MDS receiving salvage chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days

 Patients with severe aplastic anemia (SAA) receiving chemotherapy or immunosuppressive therapy using antithymocyte globulin

 Patients receiving allogeneic/autologous hematopoeitic stem cell transplant (HSCT) using myeloablative conditioning regimens

 Patients are at least 12 years of age, with Karnofsky score of 70%.?

 Patients on consolidation chemo regimens like HIDAC and HyperCVAD type B with expected duration of neutropenia (ANC < 500/ml) of at least 10 days

Exclusion criteria: :

 Patients who are human immunodeficiency virus (HIV) infected

 Patients with uncontrolled bacteremia or active pulmonary infection at the time of randomisation

 Patients with pre-existing proven and probable invasive fungal infections, according to the definitions of the invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Disease [10].

 Patients receiving concomitant piperacillin/tazobactam or co-amoxyclavulinic acid

 Patients on palliative chemotherapy

 Patients with history of allergy to triazoles

 Patients with prior history of anaphylactic reaction to conventional amphotericin B

 Patients with serum levels of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin more than 5 times the upper limit of normal or renal impairment with calculated creatinine clearance < 30ml/min

 Patients with expected life-expectancy < 72 hours

['Galactomannan antigen monitoring, Aspergillus PCR', 'blood draws', 'blood draws for GM monitoring', 'Amphotericin-B deoxycholate', 'blood test', 'Blood test']

Galactomannan antigen monitoring
Aspergillus PCR
blood draws
blood draws for GM monitoring
Amphotericin-B deoxycholate
blood test
Blood test


Megadyne Ace Incision/Dissection Study

Summary: The Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
Inclusion criteria: inclusion criteria:

 Subject is >18 years of age or < 60 years old

 Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof

 Subject is able to discontinue anticoagulant therapy (including Aspirin)

 Subject is willing and able to comply with study follow-up procedures

 Subject is willing to provide written informed consent for their participation in the study

Exclusion criteria: :

 Subject has a history of smoking in the last 6 months prior to surgery.

 Subject has a history of type I or type II Diabetes.

 Subject has an active infection of any kind at the time of enrollment

 Subject has a known coagulopathy

['Abdominoplasty', 'Bilateral Breast Reduction', 'Bilateral Breast Lift', 'Bilateral Brachioplasty', 'Bilateral Lateral Thigh and Buttocks Lift']


Characterization of Childhood-Onset Obsessive-Compulsive Disorder

Summary: The purpose of this study is to learn more about Obsessive-compulsive Disorder (OCD) in children. OCD usually has a slow onset, and symptoms that may remain at a stable level over time. A subset of children with OCD has a sudden onset and symptoms that fluctuate in severity over time. This study will also compare healthy children to those with OCD. This is an observational study; children who participate will not receive any new or experimental therapies.~OCD affects nearly 1% of the pediatric population. The symptoms of this illness can interrupt development, causing significant psychological distress and producing life-long impairments in social, academic, and occupational functioning. A subgroup of pediatric OCD has been designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections). This type of OCD is characterized by sudden symptom onset and a relapsing-remitting course of illness; exacerbation of symptoms occurs with scarlet fever or strep. throat infections. This study will identify factors that distinguish children with PANDAS OCD from children with non-PANDAS OCD, and will compare both groups to healthy children.~Children with OCD and their parents are screened with interviews and a review of the child's medical records. Participants have an initial evaluation that includes a psychiatric, physical and neuromotor exam, neuropsychological testing, psychological interviews, and a blood test. Structural magnetic resonance imaging (MRS) scans of the brain are also obtained. The MRS scan does not use radiation.~After the initial evaluation, children with OCD have follow-up visits every 6 weeks for 12 to 24 months. They are seen yearly for 8 years after the study. If they have a significant improvement or worsening of their symptoms, they are asked to make a maximum of two extra visits. Parents of OCD patients are called four times a year to discuss any changes in the child's condition between yearly visits. All participants have a 1-year follow-up visit upon study completion.
Inclusion criteria: inclusion criteria:

 OCD Participants (N = 72)

 Aged 4-12 years and living within a four-hour commute from NIH

 Currently meet DSM-IV criteria for OCD.

 Recent onset of symptoms (less than 6 months.)

 Healthy Controls (N = 60-72)

 Age and sex matched to ODC participants.

 Must be free of current or past psychopathology.

Exclusion criteria: :

 OCD Participants:

 Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever.

 Significant or unstable medical illness.

 Full scale IQ less than 80.

 Healthy Controls:

 Full scale IQ less than 80.

 Significant or unstable medical illness.


Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

Summary: The purpose of this study is to evaluate the applicability and measurement properties of bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty
Inclusion criteria: inclusion criteria:

 knee replacement surgery

Exclusion criteria: :

 pacemaker

 cardiac defibrillator

 other metallic implant than knee arthroplasty

['bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia']


Genetic Polymorphisms Associated With Cigarette Smoking and Risk of Graves' Disease

Summary: Cigarette smoking is a well-recognized risk factor of Graves' disease and, particularly, Graves' ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes belonging to the major DNA repair/apoptosis pathways might have an important role in disease susceptibility. In addition, as some of these genes are regulated by thyroid hormones, they could affect the outcome of these patients. Our objective was to assess the influence of the GST, CYP and TP53 gene polymorphisms in the risk of Graves' disease and its outcome.
Inclusion criteria: inclusion criteria:

 Graves' disease patients
Exclusion criteria:


The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery

Summary: Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.
Inclusion criteria: inclusion criteria:

 Patient undergoing heart surgery on cardiopulmonary bypass.

Exclusion criteria: :

 Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.

 End-stage renal disease.

 Inability to give informed consent.

['Acute Kidney Insufficiency', 'Acute Renal Insufficiency', 'Acute Kidney Injury', 'Ischemic Preconditioning']

Acute Kidney Insufficiency
Acute Renal Insufficiency
Acute Kidney Injury
Ischemic Preconditioning


Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer

Summary: Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung cancer. Relatives with family history of lung cancer are at increased risk of lung cancer compared to those without a family history in pooled analysis. A prospective trial using LDCT of lung to screen the relatives with family history of lung cancer is needed.
Inclusion criteria: inclusion criteria:

 relatives of the lung cancer patients;

 age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old;

 compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation.

Exclusion criteria: :

 proved lung cancer either with or without treatment,

 presence of hemoptysis or history of remarkable lung fibrosis,

 any other cancer history or

 chest CT examination within one year


Evaluation of Rapid Emergency Echography for Acute Dyspnoea

Summary: Elderly people constitute the largest proportion of emergency room patients, representing 12% of all emergency room admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population. Cardiovascular diseases and symptoms represent 12% of the causes for emergency room admission, and patients suffering from cardiovascular disease are those whose emergency room visit lasts longest.~The diagnostic approach in the emergency room in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some authors have reported up to 50% of diagnostic errors in elderly patients.~Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis. However, peptides suffer from several limitations, particularly in situations that are often encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome, pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass index. Diagnostic performance deteriorates with increasing age, and there is a significant increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left heart failure.~Some authors have suggested using lung ultrasound in the initial work-up of acute respiratory failure, since some specific profiles are known to be related to the presence of interstitial oedema, reflecting impaired left heart function (e.g. presence of B lines). These studies were performed in the context of intensive or critical care, but data are sparse regarding the application of this approach in the emergency room.~The hypothesis is that the diagnostic accuracy of a targeted and quick echographic approach, namely the READ method (Rapid Echography for Acute Dyspnoea), comprising targeted lung ultrasound combined with isolated measure of transmitral flow, would be superior to that of NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to the emergency department.
Inclusion criteria: inclusion criteria:

 Admission to the Emergency Department Age ≥ 75 years

 AND criteria of acute dyspnoea:

 Breathe rate ≥ 25 cycles/minute

 or PaO2 ≤ 70 mmHg

 or SpO2 ≤ 92% in room air

 or PacO2 ≥ 45 mmHg and pH ≤ 7.35 AND Electrocardiogram in sinus rhythm at admission

Exclusion criteria: :

 None

['Echocardiography according to the READ method.']


Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Essential Tremor

Summary: Recently, there has been increasing interest in performing DBS under general anesthesia, where the stimulated targets are located anatomically (i.e. on MRI) rather than physiologically via microelectrode recordings and intra-operative test stimulation. This technology has been termed asleep DBS and is performed with the patient under general anesthesia. Intraoperative imaging is utilized to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery. Because stereotactic accuracy (and surgical safety) is the surgical endpoint, there is no need for the patient to be awake during the procedure.
Inclusion criteria: inclusion criteria:

 Essential Tremor diagnosed by criteria listed in the Consensus statement of the Movement Disorders Society on Tremor

 Age 18 - 85 years of age

 Motor skills allowing for capability to complete evaluations

 Medically cleared for undergoing anesthesia and DBS surgery

Exclusion criteria: :

 Dementia per DSM-V criteria

 Medical or other condition precluding MRI

 History of supraspinal CNS disease other than Essential Tremor

 Alcohol use of more than 4 drinks per day

 Pregnancy

 History of suicide attempt

 Currently uncontrolled clinically significant depression (BDI>20)

 History of schizophrenia, delusions, or currently uncontrolled visual hallucinations


Preventing Chronic Whiplash Pain

Summary: This study is aimed at developing ways to prevent acute pain from becoming chronic pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury suggests that a person's initial emotional reactions, particularly fear of reinjury and subsequent avoidance of activity, contribute significantly to chronic pain and persistent disability. This study will treat people with WADs during the first three months after a motor vehicle accident with a behavioral and physical exercise program designed to encourage activity and discourage continued fear of movement, pain, and disability. The study will compare the effectiveness of two anxiety-reduction treatments to standard care in reducing pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle accidents.
Inclusion criteria: inclusion criteria:

 Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks
Exclusion criteria:

['Behavioral treatments', 'Physical therapy']


Suitability of Antibiotic Treatment for CAP

Summary: The duration of antibiotic treatment in community-acquired pneumonia (CAP) lasts about 9-10 days, and is determined empirically. The last North American guideline for CAP recommends using clinical stability criteria as a reference to establish the duration of antibiotic treatment, which would result in about 5 days of antibiotic use for the majority of pneumonia cases. In order to validate this proposal we propose to carry out a randomized multicenter double-blind (until the 5th day) clinical trial with adult CAP patients admitted to 4 hospitals in Euskadi. A control group (with routine treatment) will be compared with an intervention group (antibiotic treatment for at least 5 days, which will be interrupted if temperature is =< 37,8ºC for at least 48 hours and no more than one sign of clinical instability is assessed), with regards to: mortality at 15 days, clinical recovery by days 10 and 30, clinical improvement after days 5 and 10 as evaluated by PRO scales, duration of antibiotic treatment. A non-inferiority dichotomous sequential analysis will be performed (for mortality after 15 days, clinical recovery by day 10 and in follow-up at 30 days, clinical improvement after days 5 and 10, with PRO scales) as well as a superiority analysis for the duration of the antibiotic treatment. A total of 1100 patients will be recruited, following their signed consent, during the inclusion period (18 months). Stability criteria will be measured daily. The rest of the variables will be measured at admission and by telephone on days 10 and 30.
Inclusion criteria: inclusion criteria:

 18 or older,

 admitted with CAP will be included sequentially. Pneumonia is defined as pulmonary infiltrate shown in a thoracic X-ray not known to be old,

Exclusion criteria: :

 patients with human immunodeficiency virus infection,

 immunosupressed patients (with a solid organ transplant, spelenectomy, treated with a prednisone dose of 10 mg/day or equivalent for longer than 30 days or with other immunodepressors, with neutropenia),

 those hospitalized in the 14 days prior and those living in assisted care facilities.

 pneumonia cases caused by infrequent agents (i.e. P. aerouginosa, S. Aureus) will also be excluded, as well as infectious processes requiring an extended treatment with antibiotocs (i.e. bacterial endocarditis, abscesses),

 pneumonia cases with pleural effusion requiring a drainage tube,

 patients who were deceased or admitted to ICU before randomization and those not giving their informed consent.


Middle School Matters Study

Summary: This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.
Inclusion criteria: inclusion criteria:

 7th and 8th grade students at 4 participating middle schools

 Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%)

 No imminent plans to move or change to non-participating school

 At minimum 6th grade language skills

 Agree to participate in random assignment and research interviews

 One Parent/caregiver willing to complete research interviews

Exclusion criteria: :

 Student with past or current Major Depressive Disorder (MDD) or Probable MDD

 Students with parents who do not speak English or Spanish

 Students in concurrent treatment

 Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member

 Parent not willing to complete research interviews

['Positive Thoughts and Actions Program', 'Individual Support Program']

Positive Thoughts and Actions Program
Individual Support Program


A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

Summary: To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.
Inclusion criteria: inclusion criteria

 Concurrent Treatment:

 Allowed:

 Minimal local irradiation for tumors.

 Patients must have:

 Diagnosis of AIDS or AIDS related complex (ARC).

 Neutropenia, due either to zidovudine (AZT) or HIV infection.

 Life expectancy = or > 6 months.

Exclusion criteria:

 Co-existing Condition:

 Patients with the following conditions or symptoms are excluded:

 Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following:

 Serum carotene less than 75 IU/ml.

 Vitamin A level less than 75 IU/ml.

 More than 4 foul-smelling or greasy stools per day.

 Other criteria of malabsorption.

 Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation.

 Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection.

 Concurrent Medication:

 Excluded within 4 weeks of study entry:

 Any investigational drug.

 Immunomodulating agents.

 Hormonal therapy.

 Cytolytic chemotherapeutic agents.

 Antiretroviral agent other than zidovudine (AZT).

 Excluded within 4 months of study entry:

 Suramin.

 Excluded within 3 months of study entry:

 Ribavirin.

 Patients with the following are excluded:

 Significant malabsorption.

 Tumor likely to require specific antitumor therapy during study.

 Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions.

 Uncorrected nutritional deficiencies that may contribute to neutropenia.

 Hypersensitivity to zidovudine (AZT) or other nucleoside analogs.

 Profound dementia or altered mental status that would prohibit the giving of informed consent.

 Prior Treatment:

 Excluded within 1 month of study entry:

 Transfusion.

 Excluded within 4 weeks of study entry:

 Radiation therapy to greater than 100 cm2 body area.

 Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might introduce a new inoculation of HIV during the study.

 Patients must be willing to refrain from unprotected sexual or other activities which might introduce a new inoculum of HIV during the study.