Banlangen Granules Anti-seasonal Influenza Study

Summary: This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.
Inclusion criteria: inclusion criteria:

 with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR (rRT-PCR), age between 18-65 years old, axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ，or fatigue) and one respiratory symptom (cough ，sore throat,or coryza) . Illness onset had to be within 36 hours, and informed consent was obtained.

Exclusion criteria: :

 age younger than 18 or older than 65 years old.

 patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) .

 Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%.

 Those have got suppurative tonsillitis or cough purulent sputum.

 Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease（FEV1/FVC<70％，FEV1/ predicated value<50％； or respiratory failure or right heart failure）， hepatic disease（ALT or AST≥triple ULN）, renal disease（Serum Creatinine>2mg/dL）,chronic congestive heart failure( NYHA Ⅲ-IV)

 7. Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more).

 9. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.

 10. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization.

 12. Two weeks before the test , those with acute respiratory Infection，otitis,or nasosinusitis .

 13. Those already vaccinated or who will receive influenza vaccine. 14.other reasons not suitable for enrollment based on the investigator's discretion.

['placebo of oseltamivir phosphate', 'oseltamivir phosphate', 'Banlangen (Radix Isatidis) granules', 'placebo of Banlangen(Radix Isatidis) granules']


Predicting Acute Kidney Injury After Coronary Artery Bypass Graft

Summary: Acute kidney injury after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. There have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully. The investigators attempt to evaluate the influence of perioperative clinical variables including preoperative medication, preoperative albumin level, uric acid concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic function) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft.
Inclusion criteria: inclusion criteria:

 patients who underwent coronary artery bypass surgery during between 2010 and 2012 in Samsung Medical Center

Exclusion criteria: :

 lack of postoperative creatinine or urine output data

 patients who expired within 24hours after surgery

['Coronary Artery Bypass Surgery', 'Acute Kidney Injury', 'Creatinine', 'Mortality']

Coronary Artery Bypass Surgery
Acute Kidney Injury
Creatinine
Mortality


BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients

Summary: The purpose of this study is to find out whether acute renal failure is associated with BK virus reactivation in postoperative/posttraumatic critically ill patients with severe SIRS/sepsis and shock.
Inclusion criteria: inclusion criteria:

 Critically ill, postoperative/posttraumatic patients with threatening acute renal failure

Exclusion criteria: :

 Life expectancy < 24 hours

 Participation in other trials

 Known or suspected pregnancy

['Acute Renal Failure', 'SIRS', 'Sepsis', 'Critically Ill', 'Multiple Organ Dysfunction Syndrome']

Acute Renal Failure
SIRS
Sepsis
Critically Ill
Multiple Organ Dysfunction Syndrome


Diagnosis of Patients With Low or Intermediate Suspicion of SAHS or With Comorbidity: Standard Laboratory Polysomnography Compared With Three Nights of Home Respiratory Polygraphy.

Summary: Study Objectives: Obstructive sleep apnea (OSA) diagnosis using simplified methods such as home respiratory polygraphy (HRP) is only recommended in patients with a high pre-test probability. The aim is to determine the diagnostic efficacy, therapeutic decision-making and costs of OSA diagnosis using PSG or three consecutive studies of HRP in patients with mild-moderate suspicion of sleep apnea or with co-morbidity that can mask OSA symptoms.~Design and Setting: Randomized, blinded, crossover study of three nights of HRP (3N-HRP) vs. PSG. The diagnostic efficacy was evaluated with ROC curves. Therapeutic decisions to assess concordance between the two different approaches were analyzed by sleep physicians and respiratory physicians (staff and residents) using agreement level and kappa coefficient. The costs of each diagnostic strategy were considered.
Inclusion criteria: inclusion criteria

 Patients with low or medium suspicion of Sleep Apnea

 Patients with notorious comorbidity

 Age between 18 and 75 years

 Capability to fill in written questionnaires

Exclusion criteria:

 Patients with high suspicion of sleep apnea

 Serious heart disease, resistant systemic hypertension, Suspicion of non-apneic sleep disorders, such as narcolepsy, REM behavior disorders and restless leg syndrome.

 Patients with diagnosis of SAHS

 Lack of informed consent.

['Home Respiratory Polygraphy', 'Standard Polysomnography']

Home Respiratory Polygraphy
Standard Polysomnography


Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication

Summary: This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of lower limb intermittent claudication.
Inclusion criteria: inclusion criteria:

 All ethnic groups, male or female above the age of 18 years.

 Diagnosis of mild intermittent claudication

 Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device.

 Blood pressure currently under moderate control (< 160/100mmHg)

 No current foot ulceration

Exclusion criteria: :

 Patients meeting any of the following criteria are to be excluded:

 Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol.

 Has diabetes

 Ankle Brachial Pressure Index > 0.9

 Has any metal implants

 Pregnant

 Has a cardiac pacemaker or defibrillator device

 Has recent lower limb injury or lower back pain

 Has current foot ulceration or other skin ulcers

 Has foot deformities

 Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.

['Intermittent Claudication', 'Peripheral Vascular Disease']

Intermittent Claudication
Peripheral Vascular Disease


Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement

Summary: The investigators hypothesize that patients who receive a femoral catheter with low dose epidural Depodur will experience comparable or superior pain relief than those who receive both femoral and sciatic catheters. In addition, the investigators hypothesize that the one catheter will be less time consuming to place and facilitate early ambulation of the patient.
Inclusion criteria: inclusion criteria:

 Scheduled for total knee replacement or revision of total knee replacement

 Agree to have a regional technique including neuraxial analgesia for post-operative analgesia

 Be 18 to 70 years old

 Classified as ASA score I-III

Exclusion criteria: :

 Allergic to morphine

 Allergic to local anesthetics

 Been on opioids for more than 4 weeks

 Not willing to be randomized

 On anticoagulation medications that prevent placement of epidural

 Sensitive to effects of neuraxial opioids

 BMI>35

 Severe COPD

 Obstructive sleep apnea (OSA, see below). Each patient will be asked the questions below to determine their risk for OSA (STOP questionnaire). Patients who answer yes to 3 or more of the major criteria of the STOP questionnaire and have one of the minor criteria will be excluded from the study

 STOP Questionnaire for OSA

 Major Criteria:

 S- Do you snore loudly (louder than talking or loud enough to be heard through closed doors)?

 T-Do you often feel tired, fatigued, or sleepy during daytime?

 O-Has anyone observed you stop breathing during your sleep?

 P-Do you have or are you being treated for high blood pressure?

 Minor Criteria:

 BMI>35

 Age>50 yrs

 Neck Circumference>40 cm

 Male gender


Vytorin Reexamination Study (0653A-174)

Summary: This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Inclusion criteria: inclusion criteria:

 Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time
Exclusion criteria:

['Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)']


The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS)

Summary: As both medications i.e. CC and letrozole have been shown to be effective in inducing ovulation in PCOS patients, this study was performed in order to evaluate which regime (whether CC or letrozole) is the best to be used as the first line treatment for PCOS patients with infertility for local population. The best regime will therefore could be included in the protocol of management of infertility patients with PCOS so that the quality of patients' care could be improved.
Inclusion criteria: inclusion criteria

 Age > 18 years but < 40 years old

 Was diagnosed PCOS

 Normal husband's seminal fluid analysis (SFA)

Exclusion criteria:  :

 Not having medical problems eg- renal disease, tyhroid disorder, hyperprolactinemia, liver disease.

 Other causes of anovulatory infertility


Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

Summary: This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.
Inclusion criteria: inclusion criteria:

 Age>18 years

 Premenopausal

 Symptomatic fibroids

 Fibroids accessible for focused ultrasound treatment

Exclusion criteria: :

 Desires future fertility

 Current pregnancy

 Hematocrit <30%

 Emergency room visit in last 3 months for fibroid symptoms

 History of venous thromboembolism

 Fibroids that are: >10cm, non-enhancing with contrast

 Adenomyosis

 Contraindications to undergoing MRI

 Unexplained menstrual irregularity

['MR Guided Focused Ultrasound', 'Placebo MR Guided Focused Ultrasound']

MR Guided Focused Ultrasound
Placebo MR Guided Focused Ultrasound


Genetic Analysis of Children With Cyclic Vomiting Syndrome (CVS) and Migraines

Summary: The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS).
Inclusion criteria: inclusion criteria:

 Subjects age 0-21 years old with CVS (different phenotypes). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent.

Exclusion criteria: :

 Subjects age > 22 years old Vomiting is not due to CVS or other related condition


Venous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin

Summary: The rate of venous thromboembolic events in trauma patients at high risk for deep vein thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours will be equivalent or less than a similar group of patients given a standard every 12 hour dose of low molecular weight heparin.
Inclusion criteria: inclusion criteria:

 Admitted to Scripps Mercy Trauma Service

 ≥18 Years old

 Stratified to either Significant or Highest risk of VTE by ACCP guidelines

Exclusion criteria: :

 Estimated Injury Severity Score (ISS) ≤9

 Likely to be discharged before hospital day 7

 Systemic coagulopathy defined with an International Normalized Ratio (INR) of ≥1.2

 Body Mass Index (BMI) >40

 Likely to Survive for <7 Days

 Pregnancy

 Evidence of renal insufficiency (Cr ≥1.3)

 Delayed transfer to this facility (>24 hrs)

 Prisoners

['5000 Units unfractionated Heparin Q 8 hr', '30mg enoxaparin Q12 hr']

['Venous Thromboembolic Disease', 'Deep Vein Thrombosis', 'Pulmonary Embolism']

Venous Thromboembolic Disease
Deep Vein Thrombosis
Pulmonary Embolism


Optimising the Propranolol Block Model

Summary: Optimising the propranolol block model
Inclusion criteria: inclusion criteria:

 Healthy adult male or female aged between 18 and 50 years.

 Body mass index within the range 19-29.9 kilograms/metre2

 Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7

 The subject has an increase in sGAW of >% over pre-dose baseline within 2 h of administration of 400 ug salbutamol by MDI inhaler at screening or in the 3 months before screening.

 Subject has an increase in sGaw of 25% over pre-dose baseline within 2 h following 40 ug ipratropium bromide at screening or in the 3 months before screening

 Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.

Exclusion criteria: :

 A past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject

 History of respiratory disease

 Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec

 Supine mean heart rate outside the range 45-90 beats per minute (bpm) at screening

 Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study

 Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort)

 Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 1 month

 Infected with the Hepatitis B, Hepatitis C, or HIV virus

 Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation

['Propranolol', 'Salbutamol', 'Ipratropium', 'Placebo']

Propranolol Salbutamol Ipratropium Placebo

['Pulmonary Disease, Chronic Obstructive']


Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection

Summary: RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection.~PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency syndrome and CMV infection.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs)

 CMV interstitial pneumonia based on the constellation of clinical and radiological findings

 PATIENT CHARACTERISTICS:

 Female

 Oxygen desaturation (pulse oximetry 85% on room air)

 Abnormal chest radiograph

 No CMV retinitis

 PRIOR CONCURRENT THERAPY:

 Prior ganciclovir and foscarnet sodium
Exclusion criteria:

['therapeutic allogeneic lymphocytes', 'allogeneic bone marrow transplantation', 'total-body irradiation']

therapeutic allogeneic lymphocytes
allogeneic bone marrow transplantation
total-body irradiation


Norwegian Adenomyosis Study I

Summary: Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.~The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis.~Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized.~Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes.~Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology.~The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1.~NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis
Inclusion criteria: inclusion criteria:

 Premenopausal women aged 30 - 50 years old

 scheduled for vaginal, abdominal or laparoscopic total hysterectomy

 one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia

 junction zone definable

Exclusion criteria: :

 postmenopausal women,

 pregnancy

 gynecological cancer

 GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy

 junctional zone not identifiable


Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip

Summary: This study is being done to find out why some people with mucus dripping down the back of their throat have a nagging cough while others do not cough.
Inclusion criteria: inclusion criteria:

 -

 Postnasal Drip with chronic cough:

 Postnasal drip by rhinoscopy

 Cough by visual analog scale.

 Patients have to be 18 years old or older.

 Cough-variant asthma must be excluded by a negative methacholine challenge test within one year, or documented failure of chronic cough to resolve after administration of inhaled corticosteroid (> one-month duration). Asthma is defined by the ATS guidelines.

 Subjects must have a negative chest radiogram or Chest CT scan within 6 months.

 No active GERD symptoms (< 7 RSI score) & a stable dose of Proton Pump Inhibitor (4 weeks).

 Eligibility Criteria of Postnasal Drip without cough:

 Postnasal drip by rhinoscopy

 No cough by visual analog scale.

 Patients have to be 18 years old or older.

Exclusion criteria: :

 Subject


Internet-Based Program to Improve Asthma Management in Children

Summary: Asthma is a respiratory condition that affects millions of children. It can be controlled, however, with the proper medications and treatment. AsthmaNet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback related to asthma management. The purpose of this study is to evaluate the effectiveness of AsthmaNet at improving quality of care and controlling asthma symptoms in children.
Inclusion criteria: inclusion criteria:

 Asthma

 Receives asthma care at a clinic in Western Washington

 Has access to the internet at home

Exclusion criteria: :

 Does not speak or read English


Direct Current Brain Polarization in Frontotemporal Dementia

Summary: This pilot study will evaluate the effect of direct current (DC) electrical polarization of the brain on language, memory, reaction time, and mood in six patients with frontotemporal dementia (Pick's disease). There is no effective treatment available for cognitive impairment in patients with this condition. DC polarization sends a very weak current between two sponge pads placed on the head. In a previous study in healthy volunteers, DC polarization of the left prefrontal area of the brain increased verbal fluency, memory and attention, and motor reaction time in the study subjects.~Patients between 35 and 75 years of age with frontotemporal dementia who have been referred to NINDS's Cognitive Neuroscience Section for an existing protocol will be offered participation in this study. Candidates will be screened with a neurological examination to confirm the diagnosis of frontotemporal dementia.~Participants receive 40 minutes of DC polarization or sham polarization in each of two separate sessions. (No current is applied in the sham treatment). During the polarization, the patient rests quietly. Sponge pads that have been soaked in water are put on the left side of the head and above the right eye, and are held in place with elastic netting. Before the polarization and after about 20 minutes of polarization, patients undergo the following tests:~Language: Patients must say as many words beginning with certain letters as they can in 90 seconds.~Memory: Patients must remember a letter on a computer screen, and when the letter appears again, press the same letter on the keyboard.~Reaction time: Patients place pegs on a pegboard.~Mood: Patients place a mark on a line ranking how they feel.
Inclusion criteria: inclusion criteria:

 -Six patients referred to the Cognitive Neuroscience Section, NINDS, with a clinical diagnosis of FTD confirmed here, will be selected to participate in the study.

Exclusion criteria: :

 Greater than 75 years of age.

 Presence of metal in the head other than dental hardware.

 Broken skin in the area of the stimulating electrodes.

 Any behavioral disorder that makes testing impossible.

 Children are excluded, as FTD is not a childhood illness.


Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder

Summary: This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience.
Inclusion criteria: inclusion criteria:

 Male and female outpatients, aged 18 to 75 years.

 Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II).

 Current diagnosis of Generalized Anxiety Disorder (GAD).

 Participants must be on at least one of the following mood stabilizers at steady dose for at least 4 weeks prior to randomization: lithium with blood levels between 0.4-1.4 meq/L, valproic acid/divalproate sodium (with levels between 50-150 ugm/dl) carbamazepine (blood levels between 4-12 mcg/ml), or lamotrigine (dosed 50-400 mg/day).

Exclusion criteria: :

 Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).

 Patients with current or history of schizophrenia, or patients with current mania, hypomania at study entry. Lifetime psychosis and dementia are exclusionary.

 Patients with current obsessive-compulsive disorder or posttraumatic stress disorder are excluded.

 Patients with a history of alcohol or substance abuse or dependence within the last three months.

 Patients with significant unstable medical illness likely to result in hospitalization or acute medical care. In addition, patients with an established diagnosis of diabetes mellitus are excluded.

 Current cognitive behavioral therapy directed toward the treatment of generalized anxiety disorder.

 History of hypersensitivity to or lack of response to ziprasidone.

 Concomitant treatment with other typical or atypical antipsychotics; patients should be off other typical or atypical antipsychotics for at least one week prior to study baseline.

 Patients with significant suicidal ideation or who have enacted suicidal behaviors within 3 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.

 Patients who have had a psychiatric hospitalization (including for bipolar disorder) in the past 3 months are excluded.

 Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood, were isolated, and did not recur in adulthood.

 History of Neuroleptic Malignant Syndrome.

 Individuals with current clinically significant orthostatic hypotension are excluded.

['Generalized Anxiety Disorder', 'Bipolar Disorder']

Generalized Anxiety Disorder
Bipolar Disorder


Genes in Predicting Outcome in Patients With Esophageal Cancer Treated With Cisplatin, Radiation Therapy, and Surgery

Summary: RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment.~PURPOSE: This laboratory study is looking at genes to see if they can predict outcome in patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Diagnosis of adenocarcinoma of the esophagus

 Stage I-IV disease

 Received cisplatin-based treatment on clinical trial ECOG-1201

 PATIENT CHARACTERISTICS:

 Not specified

 PRIOR CONCURRENT THERAPY:

 Not specified
Exclusion criteria:

['loss of heterozygosity analysis', 'polymerase chain reaction', 'polymorphism analysis']

loss of heterozygosity analysis
polymerase chain reaction
polymorphism analysis


Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation

Summary: The study will be conducted as a community-based, randomized, placebo-controlled, trial with four study groups. The overall objective of the study is to determine the optimal method for delivering zinc to young children, both for the prevention of zinc deficiency and treatment of diarrhea. In particular, the investigators plan to compare the impact on physical growth, morbidity, micronutrient status, immune function, environmental enteric dysfunction, parasite burden and hair cortisol concentration of: 1) daily preventive zinc supplementation as a micronutrient powder (MNP); 2) placebo powders; 3) daily preventive zinc supplementation as dispersible tablets; 4) therapeutic zinc supplementation as dispersible tablets given in relation to episodes of diarrhea.~In addition to the major outcomes mentioned above, the investigators will monitor adherence to the interventions, neuro-behavioral development, and the occurrence of any adverse events.
Inclusion criteria: inclusion criteria:

 Signed informed consent from at least one parent or primary caregiver

 Age 6-23 months initially

 Permanent resident of study area

 Planned availability during the period of the study

 Acceptance of home visitors

Exclusion criteria: :

 Weight-for-height z-score (WHZ) <-3Z with respect to WHO 2006 standards

 Presence of bipedal edema

 Severe illness warranting hospital referral

 Congenital abnormalities potentially interfering with growth

 Chronic medical condition (e.g. malignancy) requiring frequent medical attention

 Known HIV infection of index child or child's mother

 Hemoglobin <70 g/L

 Currently consuming zinc supplements

 Current participation in any other clinical trial

['MNP', 'preventive zinc supplement', 'therapeutic zinc supplement', 'preventive placebo supplement', 'therapeutic placebo supplement', 'placebo powder']

MNP
preventive zinc supplement
therapeutic zinc supplement
preventive placebo supplement
therapeutic placebo supplement
placebo powder


Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475

Summary: This is a prospective, observational pilot study that will describe the safety profile and biological effects of combining stereotactic ablative body radiosurgery (SABR) treatment (20Gy/1#) and a PD-1 antibody, MK-3475.~15 patients with oligometastatic breast cancer with at least one lesion considered safe for SABR radiotherapy, will be treated with SABR for their oligometatastic disease in addition to 6 months of MK-3475 treatment (1 cycle every 3 weeks, a total of 8 cycles).~This investigator driven pilot study will examine the safety and biological effects of combining MK-3475 (Pembrolizumab) an antibody targeted against the anti-programmed cell death 1 (PD-1) T cell checkpoint, with SABR therapy for oligometastatic disease. We hypothesise that the safety profile of this combination, will be clinically acceptable and well tolerated for patients, and that we will observe evidence of systemic immune activation.
Inclusion criteria: inclusion criteria:

 Be willing and able to provide written informed consent/assent for the trial.

 Be 18 years of age on day of signing informed consent.

 Have histologically or cytologically confirmed breast cancer. Oligometastatic lesions do not need to be biopsied but they must be strongly suspected to represent metastatic disease.

 CT scan (Chest, Abdo + Pelvis), Whole Body Bone scan, and FDG-PET scan evidence of 1 to 5 metastases within 8 weeks of study registration.

 Note: At least 1 of the 5 metastases must be deemed suitable for SABR treatment.

 Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen only upon agreement from the study P.I's.

 Have a performance status of 0-2 on the ECOG Performance Scale.

 Demonstrate adequate organ function.

 Life expectancy > 12 months.

 Be willing and able to comply with all study requirements, including treatment, attending assessments and follow-up.

 Female patients of childbearing potential must have a negative urine or serum pregnancy within 7 days of study registration and re-tested within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

 Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through to 120 days after the last dose of MK-3475. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.

 Male patients must agree to use an adequate method of contraception starting with the first SABR treatment, through to 120 days after the last dose of MK-3475.

Exclusion criteria: :

 Previous high dose radiotherapy (biological equivalent of 20 Gy in 5 fractions to the area to be treated).

 Evidence of visceral metastases in liver or brain.

 Treatment with any chemotherapy agent within +/- 3 weeks of SABR. Targeted therapy or endocrine therapy is permitted at any stage during the conduct of this study, however is not to be changed during the study period unless due to progression.

 Evidence of Spinal Cord Compression.

 Spinal Instability Neoplastic Score greater than or equal to 7 unless lesion reviewed by a neurosurgical service and considered stable.

 Surgical fixation of lesion required for stability.

 Lytic metastases in a long bone (femur or humerus) that which erodes the cortex.

 Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.

 Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Single once of doses are acceptable.

 Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. Patients must not be receiving denosumab on this study.

 Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent.

 Note: Subjects with less than or equal to Grade 2 neuropathy are an exception to this criterion and may qualify for the study.

 Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.

 Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.

 Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.

 Has an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.

 Has evidence of interstitial lung disease or active, non-infectious pneumonitis.

 Has an active infection requiring systemic therapy.

 Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

 Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

 Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

 Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).

 Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

 Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

 Has received a live vaccine within 30 days prior to the first dose of trial treatment.

 Known active tuberculosis

 Known hypersensitivity to Pembrolizumab or its exicipients

['Stereotactic Ablative Body Radiosurgery (SABR)', 'MK-3475']


Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep

Summary: The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with pulmonary hypertension or with interstitial lung disease.
Inclusion criteria: inclusion criteria:

 Precapillary pulmonary hypertension, or interstitial lung disease.

 New York Heart Association class 2-3.

 Residence at low altitude (<800m).

Exclusion criteria: :

 Unstable or exacerbated condition

 Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4

 requirement for oxygen therapy at low altitude residence

 hypoventilation

 more than mild or unstable cardiovascular disease

 use of drugs that affect respiratory center drive

 internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.

 previous intolerance to moderate altitude (<2600m).

 Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study.

 Pregnant or nursing patients

['Moderate altitude sojourn', 'Low altitude sojourn', 'Oxygen', 'Sham oxygen (room air)']

Moderate altitude sojourn
Low altitude sojourn
Oxygen
Sham oxygen (room air)

['Precapillary Pulmonary Hypertension', 'Interstitial Lung Disease']

Precapillary Pulmonary Hypertension
Interstitial Lung Disease


Physical Exercise for Prevention of Dementia

Summary: The principal aim of this study is to verify whether a program of supervised, multimodal physical exercise improves cognitive function and/or reduces the rate of cognitive decline in older adults
Inclusion criteria: inclusion criteria:

 Age > 50 years old

Exclusion criteria: :

 Medical conditions that compromise survival or limit physical activity

 Geriatric Depression Scale-15 score of 6 or higher

 Alcohol intake > 4 units/day

 Mini- Mental State Examination < 24

 Clinical Dementia Rating score of 1 or more

['Memory Disorders', 'Mild Cognitive Impairment', 'Aging']

Memory Disorders
Mild Cognitive Impairment
Aging

inclusion criteria:

 Age > 50 years old


Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation

Summary: The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of care antidepressants in the acute management of suicidality in depressed subjects.~Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still underway.
Inclusion criteria: inclusion criteria:

 Male and female subjects who are able to provide informed consent

 19-65 years of age

 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of MDD by MINI International Neuropsychiatric Interview (MINI) and confirmed by psychiatric interview

 Currently experiencing a depressive episode with suicidality (defined as having current suicidal thoughts occurring at least 3 out of 7 days in a week).

 Montgomery-Asberg Depression Rating Scale (MADRS) must include a total score > 25 and a suicidal sub-score > 4.

Exclusion criteria: :

 Depressed patients without suicidality, patients with severe psychotic features or with primary diagnoses of bipolar disorder (BD), schizophrenia, schizoaffective disorder, or generalized anxiety disorder (GAD), and subjects who have been taking lithium or an antipsychotic in the past 2 weeks

 Those with uncontrolled medical illnesses. Participants must be on any new medications for at least 30 days to be considered medically stable.

 For patients with panic disorder, post-traumatic stress disorder (PTSD), borderline personality disorder (BPD), etc. be sure that MDD is the primary diagnosis. When in doubt, decisions will be made on a case-by-case basis.

 Pregnant women.

 Allergic to paliperidone, to any other ingredient in paliperidone ER or paliperidone palmitate, or to risperidone.

['Major Depressive Disorder', 'Suicidal Ideation']

Major Depressive Disorder
Suicidal Ideation


Asthma Clinical Research Network (ACRN)

Summary: This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
Inclusion criteria: Patients with asthma; specific eligibility criteria vary for each study.
Exclusion criteria:

['Albuterol', 'Colchicine', 'Adrenal Cortex Hormones', 'Adrenergic-Beta Agonists']

Albuterol
Colchicine
Adrenal Cortex Hormones
Adrenergic-Beta Agonists


Lithium for Suicidal Behavior in Mood Disorders

Summary: Observational evidence and findings from clinical trials conducted for other reasons suggest that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent, depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has not yet been adequately examined in a randomized clinical trial conducted specifically to test lithium's efficacy in preventing suicides. This clinical trial fills this gap.~This study is feasible within the Department of Veterans Affairs (VA) because it is a large, integrated health system with existing programs for identifying patients at risk for suicide and delivering enhanced services. In VA, approximately 12,000 patients with depression or bipolar disorder survive a suicide attempt or related behavior each year, and 15% of them repeat within one year. Experimental treatment in this study will supplement usual care for major depression or bipolar disorder, as well as VA's standard, enhanced management for patients at high risk.~The investigators will recruit 1862 study participants, from approximately 30 VA Hospitals. Participants will be patients with bipolar disorder or depression who have survived a recent episode of suicidal self-directed violence or were hospitalized specifically to prevent suicide. Randomly, half will receive lithium, and half will receive placebo. Neither the patients nor their doctors will know whether a particular person has received lithium or placebo. The treatment will be administered and the patients will be followed for one year, after which patients will go back to usual care. Recruitment will occur over 3 years.~The investigators are primarily interested in whether lithium leads to increases in the time to the first repeated episode of suicidal behavior, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. In addition, this study will allow us to explore whether lithium decreases the total number of suicidal behaviors, and whether it has comparable effects on impulsive and non-impulsive behaviors. If there is an effect of lithium, the investigators will be interested in whether or not it could be attributed to improved control of the underlying mental health condition, or, alternatively, whether it represents a direct effect of suicide-related behavior.
Inclusion criteria: inclusion criteria:

 Must be a Veteran of the United States Armed Forces

 Survived an episode of suicidal self-directed violence (including suicide attempts and interrupted attempts) that occurred within six months of admission to the study, or they were admitted within the past six months to a mental health inpatient unit specifically to prevent suicide

 Have a diagnosis of an affective disorder meeting DSM-IV-TR (2000) criteria for Bipolar I Disorder, Bipolar II Disorder, or current or recurrent Major Depressive Disorder

 Are able and willing to identify one or more family members, friends, or other contacts and give permission for both clinical providers and the Research Team to contact them if the patient cannot be reached

 Are able to provide informed consent

 There is concurrence from the patient's mental health provider about inclusion/
Exclusion criteria:  and confirmation of the providers' willingness to work with the research team in managing the patient during the course of the study. The provider responsible for the patient's general medical care has been made aware of the participation

 Must be registered at a VA Medical Center

['Depressive Disorder', 'Bipolar Disorder', 'Suicide', 'Suicide, Attempted']

Depressive Disorder
Bipolar Disorder
Suicide
Suicide
Attempted


An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

Summary: Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate
Inclusion criteria: inclusion criteria:

 Histologically confirmed MTC with signs of residual/persistent disease based on tumor marker levels and/or radiographic imaging. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC.

 Elevated neuroendocrine markers at least 1 month post -op. In MTC, persistently elevated neuroendocrine markers such as calcitonin and CEA are indicative of persistent disease.

 Disease progression is not required for this trial

 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration. Subjects will have had standard of care prior to enrollment. Subjects will have had standard of care prior to enrollment (for example it could include total thyroidectomy, central lymph node dissection, and when necessary ipsilateral radical neck dissection but is tailored to the patient).

 3 weeks from the completion of radiation therapy to study registration

 The following laboratory values obtained within 14 days prior to registration:

 Absolute neutrophils count (ANC) ≥ 1000/mm3

 Platelets ≥ 75,000/mm3

 Hemoglobin ≥ 8.0 g/dL

 Total bilirubin greater than or equal to 2.0 X the upper limit of normal (ULN)

 AST greater than or equal to 3 X ULN or greater than or equal to 5 X ULN if liver metastases are present

 Creatinine greater than or equal to ULN

 Serum sodium within normal limits

 ECOG performance status of 2

 Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.

 Availability of tissue specimens to be analyzed for pathologic confirmation.

 Age ≥ 18 years.

 Women must not be pregnant or lactating due to the deleterious effects of Lithium carbonate on a fetus or small child. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.

 Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception.

 Patients must not have known history of allergic reactions or adverse reactions to Lithium or its derivatives.

 Patients are not allowed to be on concurrent chemotherapy or radiation therapy.

Exclusion criteria: :

 Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets).

 Significant, active cardiac disease

 Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, and COX2 inhibitors.

 Patients with radiographic evidence of disease will be presented the option to undergo a tumor biopsy although this is not mandatory.

 Patients already taking Lithium for any reason are not allowed on study


European Sleep Apnea and Sudden CArdiac Death ProjEct

Summary: The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The ESCAPE - SCD Study will address following specific study questions:~Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC) Guidelines for primary prevention of sudden cardiac death?~Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM patients?~Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant?~Does obstructive sleep apnea represent a novel factor that may improve risk stratification of sudden cardiac death and advance identification of those patients that will benefit from ICD/CRT-D therapy?
Inclusion criteria: inclusion criteria:

 Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death

Exclusion criteria: :

 Previously diagnosed sleep apnea CPAP, BiPAP or ASV treatment

 Patients with previously implanted ICD/CRT-D device indicated for device replacement

 Uncontrolled hypertension

 Severe valvular heart disease/dysfunction with exception of ischemic and functional mitral regurgitation

 Acute coronary syndrome or acute cardiac decompensation in 4 weeks before ICD/CRT-D implant

 Expected indication of heart transplant in period of 12 months or less after ICD/CRT-D implant

 Expected cardiac surgery or percutaneous coronary intervention in period of 12 months or less after ICD/CRT-D implant

 Severe pulmonary diseases

 Rejection of participation in the study

 Pregnancy

 Age of 80 years and higher in time of ICD/CRT-D implant

['Sleep Apnea', 'Sudden Cardiac Death', 'Heart Failure', 'Ischemic Cardiomyopathy']

Sleep Apnea
Sudden Cardiac Death
Heart Failure
Ischemic Cardiomyopathy


EXCEL Clinical Trial

Summary: To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.
Inclusion criteria: inclusion criteria:

 * inclusion criteria for RCT:

 Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥70% requiring revascularization, or

 ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with one or more of the following present:

 Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or

 IVUS minimum lumen area (MLA) <= 6.0mm2, and/or

 Fractional Flow Reserve (FFR) <=0.80

 Left Main Equivalent Disease

 Clinical and anatomic eligibility for both PCI and CABG

 Silent ischemia, stable angina, unstable angina or recent MI

 Ability to sign informed consent and comply with all study procedures including follow-up for at least three years

Exclusion criteria: :

 * Clinical

['Percutaneous Coronary Intervention', 'CABG']

['Chronic Coronary Occlusion', 'Unprotected Left Main Coronary Artery Disease', 'Stent Thrombosis', 'Vascular Disease', 'Myocardial Ischemia', 'Coronary Artery Stenosis', 'Coronary Disease', 'Coronary Artery Disease', 'Coronary Restenosis']


NT-proBNP as a Tool for the Detection of Acute Pulmonary Artery Embolism (APE)

Summary: In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were measured according to the standard hospital protocol. To definitively confirm or exclude APE, all patients underwent an angiographic CT-scan of the thorax.
Inclusion criteria: inclusion criteria:

 all patients referred to the ICU with suspected APE

Exclusion criteria: :

 none

['Pulmonary Embolism', 'Pulmonary Embolism Without Mention of Acute Cor Pulmonale']


Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis.

Summary: Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years old. Ten percent of the population will get this disease during a lifetime. At Bispebjerg hospital it is one of the most common acute surgeries performed. Though at Bispebjerg hospital the surgery is only performed on adults as there is no pediatric ward. The surgical technique is primarily laparoscopic surgery, where the patients have their appendix removed while in general anaesthesia. During the last three years Bispebjerg hospital has had an average of 287 patients per year undergoing laparoscopic surgery. From January to the September 2012 a total of 211 patients have had the operation, with 29% having the operation performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only performed in cases where laparoscopic surgery is impossible, this is often due to adhesions, scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery are usually smaller than that from an open appendectomy, but it gives the patient three smaller scars divided on three abdominal quadrants instead of one larger scar on one quadrant.~The investigators want to conduct a clinical trial with fifty six patients undergoing laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is possible to improve the post-operative pain management within this very large group of patients undergoing acute surgery. In detail, the investigators wish to explore whether the use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery due to acute appendicitis, can anesthetize the patients completely or partially, so they can avoid morphine intake completely or partially during the post-operative phase (12-24 hours). The research project will be a randomized, double-blinded, controlled clinical trial.
Inclusion criteria: inclusion criteria:

 Age above 18 years

 Patients undergoing diagnostic laparoscopy for acute appendicitis

 American Society of Anaesthesiology group 1-3

 General Anaesthesia

Exclusion criteria: :

 Inability to cooperate

 Inability to understand and talk danish

 Allergic to ropivacaine

 Drug and alcohol abuse

 Pregnancy or nursing


Study on Laparoscopic Operation for Perforated Appendicitis

Summary: The purpose of this study is to conduct a prospective observational study for the open approach and laparoscopic approach for perforated appendicitis. It is also designed to investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating perforated appendicitis with laparoscopic operation.
Inclusion criteria: inclusion criteria:

 All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant.

 The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation.

 Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent.

Exclusion criteria: :

 Age less than 12 years

 older than 80 years

 perforated appendicitis was not revealed by pathologic investigation

 diverticulitis being diagnosed during surgery

 pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation

 the patient declining to enroll in this study

['Laparoscopic appendectomy', 'Open appendectomy']

Laparoscopic appendectomy
Open appendectomy


Performance Evaluation of Pupillary Reactivity in Monitoring of Brain-damaged Patients in Intensive Care

Summary: The pupillary examination is a major component of the clinical examination and monitoring of brain-damaged patients in intensive care. The occurrence of abnormal size or pupillary reactivity is a prognostic factor of poor neurological outcome or an indicator of the neurological status degradation. To date, the monitoring of the pupils is clinical. The subjectivity of this measure and, the lack of reproducibility and definition of the abnormality remain as many obstacles to the development of a monitoring of early neurological deterioration. The recent development in pupillometer electronics allows the assessment of responsiveness to a calibrated light stimulus. It offers a reliable and reproducible measure of the pupil diameter. The pupillometers were funded by the association of  Gueules Cassées .~This study aims to establish a relationship between an abnormal pupillary reactivity detection by the electronic pupillometer and a deterioration in neurological status of the patient brain-damaged in the intensive-care unit (ICU). This is considered clinically relevant and has been defined by a lower Glasgow Coma Score of at least 2 points for 2 hours or involving a therapeutic action. If this relationship is demonstrated, the temporal relationship between data pupillometry and the patient's neurological status remain to be established more precisely. This is particularly relevant in neurosurgical context and aim to define the status of the electronic pupillometer in intensive care but also in emergency rooms services, the neurovascular units or in the pre-hospital care.~Therefore the investigators will compare the pupillometry data in two patients groups, defined accordingly to the appearance or absence of neurological aggravation in the first 5 days of treatment in intensive care, time-frame defined as the maximum risk period in patients with brain damage. The primary endpoint is represented by the estimated area under the ROC curve corresponding to the last measure of the change in pupil size before the onset of neurological deterioration and worse for the fifth day for non-aggravated.~Thus the investigators propose to conduct a prospective trial, aiming to record the diagnostic value of pupillary reactivity by the electronic pupillometer in the monitoring of the neurological aggravation of brain damaged patient in ICU. The duration of the follow-up for a subject does not exceed 5 days. The statistical analysis requires the recruitment of 90 patients, which sets the length of the inclusions to 14 months.
Inclusion criteria: inclusion criteria:

 male or feminine Subjects of 18 or more years old.

 Patients cérébro - hurt presenting disorders(confusions) of the consciousness (Score of Glasgow < 9) and justifying an hourly pupillary surveillance(supervision) in the middle of neurosurgical resuscitation. (Definition of the Score of Glasgow in appendix)

 acute(sharp) intellectual Aggression bound(connected) to a cranial trauma, a meningeal bleeding by break of anévrysme, a cerebral vascular accident, an intra-cranial expansive process, a post-operative neurosurgical complication, an intra-cranial high blood pressure of medical origin (méningo-encephalitis, hypertensive encephalopathy)

 Admission in resuscitation within first 48 hours of the aggression

Exclusion criteria: :

 Subject having a direct eye trauma, as well as any history which can affect(allocate) the relevance of the pupillary examination (anophthalmia, cataract(waterfall) opalescente, surgery irienne, blindness, reached(affected) by III prerequisite, that the character of these affections is bilateral or unilateral).

 presenting Subject of the signs of irreversible coma in the admission.

 minor Subject, pregnant or breast-feeding woman, subject deprived of freedom, subject not being affiliated to the national insurance scheme.


Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma

Summary: The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery.~The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%).~Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma.~Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.
Inclusion criteria: inclusion criteria:

 Adenocarcinoma of the rectum classified clinically T2, T3a, T3b (penetration in the mesorectal fat between 1 to 5 mm) by TNM classification (Tumour Node Metastase), < 5 cm largest diameter, < half rectal circumference (by MRI staging), N0-N1 (any node < 8 mm diameter on MRI), M0

 Operable patient

 Tumour accessible to endocavitary contact X-Ray Brachytherapy with a distance from the lower tumour border to the anal verge ≤ 10cm

 18 years or above

 No comorbidity preventing treatment

 Adequate birth control

 Patient having read the information note and having signed the informed consent

 Health care insurance available

 Follow-up possible

Exclusion criteria: :

 Inoperable patient

 T1, T3cd, T4, T≥ 5cm, T≥ ½ circumference

 Patient N2 at diagnosis or N1 with any node > 8 mm diameter

 Patient presenting metastasis at diagnosis

 Previous pelvic irradiation

 Tumour with extramural vascular invasion

 Simultaneous progressive cancer

 Tumour invading external anal sphincter and within 1 mm, and the levator muscle

 Patient unable to receive CXB or CRT

 Tumour with poor differentiation (G3)

 People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside state to express their consent, pregnant or breastfeeding women

 Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy

 Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol

 Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment

['3D conformal EBRT', 'Contact X-ray brachytherapy 50 kV', 'Capecitabine']

3D conformal EBRT
Contact X-ray brachytherapy 50 kV
Capecitabine


Low Doses of Cholestyramine in the Treatment of Hyperthyroidism

Summary: The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis.Bile-salt sequestrants (ionic exchange resins) bind thyroid hormones in the intestine and thereby increase their fecal excretion. Based on these observations, the use of cholestyramine has been tried. The present study evaluates the effect of low doses of cholestyramine as an adjunctive therapy in the management of hyperthyroidism
Inclusion criteria: inclusion criteria:

 Patients with newly diagnosed hyperthyroid Graves' disease

Exclusion criteria: :

 If the patient had been treated previously

 diabetes, kidney, or liver disease

['Cholestyramine', 'Cholestyramine', 'Placebo powder']

Cholestyramine
Cholestyramine
Placebo powder


To Determine the Maximum Tolerated Dose (MTD) of BIBF 1120 in Patients With Solid Tumours

Summary: The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.
Inclusion criteria: inclusion criteria:

 Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment

 Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound)

 Age 18 years or older

 Life expectancy of at least three months

 Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation)

 Eastern Cooperative Oncology Group (ECOG) performance score < 2

 Full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy

Exclusion criteria: :

 History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing

 Pregnancy or breastfeeding

 Active infectious disease

 Brain metastases requiring therapy

 Absolute neutrophil count less than 1500 / mm3

 Platelet count less than 100 000 / mm3

 Bilirubin greater than 1.5 mg / dl (> 26 μmol / L, International System of Units (SI unit) equivalent)

 Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)

 Serum creatinine greater than 1.5 mg / dl (> 132 μmol / L, SI unit equivalent)

 Uncontrolled, severe hypertension

 Gastrointestinal disorders anticipated to interfere with the resorption of the study drug

 Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol

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

 Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)

 Patients unable to comply with the protocol

 Active alcohol or drug abuse


Web-based Genetic Research on Lupus

Summary: The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator's partners at Pfizer.
Inclusion criteria: inclusion criteria:

 diagnosed with lupus by a qualified physician.

 consents to have 23andMe (via a partner) contact the physician to obtain medical record information

 willing to submit a saliva sample for DNA testing and complete online surveys related to condition

 at least 6 years old (minors under 18 require parental consent to enroll)

 access to the internet

 resides in the United States

Exclusion criteria: :

 -


Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

Summary: The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia
Inclusion criteria: Key inclusion criteria:

 The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness.

 Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit.

 The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.

 Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence.

 The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits.

 Key
Exclusion criteria: :

 The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale.

 The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study.

 The patient has moderate to severe depressive symptoms, as indicated by the CDSS.

 The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.

 The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.

 The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies.

 The patient is a pregnant or lactating woman.

 The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.

['armodafinil', 'placebo', 'armodafinil', 'armodafinil']

armodafinil placebo armodafinil armodafinil


Detection of Genetic Markers of Lung Cancer

Summary: The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.
Inclusion criteria: inclusion criteria:

 Histologic confirmation of lung cancer, lung metastases from a primary site other than lung, mesothelioma or a radiographic lesion highly suspicious for malignancy

 Written informed consent.

 Must be scheduled for a biopsy or surgical resection

Exclusion criteria: :

 None

['Biopsy of the major carinal area', 'Biopsy of abnormal & suspicious areas of the bronchial tree', 'Evaluation of the tumor for DNA mutations', 'Bronchoalveolar Lavage (BAL) for cytokine analysis', 'Correlation of flow cytometric & RT PCR for TNM stage', 'Analysis of lymph nodes']


Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France

Summary: This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.
Inclusion criteria: inclusion criteria:

 Recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor

 Subject, who has given his/her oral consent for participation

Exclusion criteria: :

 Subject included in clinical trial or having participated in a clinical trial during the last 3 months

 Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term)

 All contraindications to Lévothyrox


Methylphenidate for Treating Children With ADHD and Tourette Syndrome

Summary: This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder in children with both attention deficit hyperactivity disorder and Tourette syndrome.
Inclusion criteria: inclusion criteria:

 Diagnosis of ADHD or ADHD plus Tourette syndrome

Exclusion criteria: :

 Determined to be dangerous to self or others

 Scores less than 70 on an IQ test

 Any seizure disorder, major organic brain dysfunction, major medical illness, major mood disorder, psychosis, pervasive developmental disorder, or peripheral sensory loss

 Any condition that may make use of methylphenidate unsafe

['Attention Deficit Disorder With Hyperactivity', 'Tourette Syndrome']


Antithyroid Drugs During Radioiodine Therapy

Summary: Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves' disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced 'thyroid storm', which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves' disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have 'radioprotective' properties, although this view is almost exclusively based on retrospective data and is still under debate (13). Indeed, this dogma was recently challenged by two randomized trials in Graves' disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients. The continuous use of ATD during 131I therapy leads to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues. Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the evidence is based on retrospective studies and the ideal set-up should be reconsidered. To underscore the importance of performing randomized trials we showed recently that resumption of methimazole seven days after 131I therapy had no influence on the final outcome.~Aim: To clarify by a randomized trial whether continuous use of methimazole during radioiodine therapy influences the final outcome of this therapy, in a comparison with a regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine.~Patients and Methods: 80 consecutive patients suffering from recurrent Graves' disease or a toxic nodular goiter are included. All patients are rendered euthyroid by methimazole (MMI) and randomized either to stop MMI eight days before 131I or to continue MMI until four weeks after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume. Patients are followed for one year with close monitoring of the thyroid function.
Inclusion criteria: inclusion criteria:

 Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves' disease or toxic nodular goiter.

Exclusion criteria: :

 Age < 18 yrs.

 Allergy to anti-thyroid drugs

 Substernal or large (> 100ml) goiter

 Severe endocrine ophthalmopathy

 Pregnancy or lactation

 Suspicion of thyroid malignancy

 Unsafe contraconception

 Physical or mental condition that hinders corporation

['Toxic Nodular Goitre', 'Graves Disease']


A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis

Summary: To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and on the relationship between microsporidial counts in stool and stool frequency and volume. To correlate microsporidial counts with the clinical course of microsporidiosis.
Inclusion criteria: inclusion criteria

 Concurrent Medication:

 Required:

 If coincident enteric pathogens that are not eradicable (i.e., Mycobacterium avium complex) are detected, they should be treated appropriately and the patient must be on a stable regimen of therapy for at least two weeks.

 Allowed:

 Patients taking antidiarrheal medications must be on a stable regimen for at least seven days prior to randomization.

 Patients taking other concomitant medications, including antiretrovirals, must be on a stable regimen for two weeks prior to randomization.

 Patients must have:

 HIV positive status. Written documentation (for example, patient's chart) of HIV diagnosis is acceptable in lieu of repeat testing. Confirmation by Western blot is not necessary.

 Biopsy-proven microsporidiosis of the fourth portion of the duodenum or proximal jejunum within 90 days before randomization.

 Average of > 3 liquid bowel movements per day over 7 consecutive days immediately prior to randomization, with an average volume > 500 ml per day over three or more consecutive days immediately prior to randomization, as documented by data collected in a daily diary. NOTE:

 Patients receiving antidiarrheal therapy must meet these criteria despite such therapy.

 History of an average of > 3 liquid bowel movements per day for three additional weeks immediately preceding the 7-day period described above (for a total of four weeks), as documented in the patient's chart.

Exclusion criteria:

 Co-existing Condition:

 Patients with the following symptoms or conditions are excluded:

 Grade 4 neutropenia.

 Decompensated liver disease.

 Positive toxin analysis for C. difficile.

 Positive microscopic examination for Giardia lamblia, Entamoeba histolytica, and Isospora belli.

 Positive on culture for Shigella, Salmonella, Yersinia and Campylobacter.

 Positive fluorescent antibody test for Cryptosporidium.

 Evidence of CMV on small bowel biopsy, flexible sigmoidoscopic or colonoscopic biopsies within 90 days of randomization.

 Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study entry.

 Patients with the following prior conditions are excluded:

 Hypersensitivity to albendazole.

 Prior Medication:

 Excluded:

 Use of potential antiprotozoal drugs, e.g., mebendazole or metronidazole, within one week prior to enrollment.

 Receipt of albendazole during the one month prior to enrollment.

['Protozoan Infections', 'HIV Infections']


Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

Summary: The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.
Inclusion criteria: inclusion criteria:

 Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD

 Current smokers or ex-smokers

 A post-bronchodilator FEV1 < 60% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7

 Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5%.

 BDI score ≤ 10

 Patients free of exacerbations for at least 1 month

Exclusion criteria: :

 Pregnant or lactating women

 Diagnosis of asthma

 Patients treated for exacerbations in the 4 weeks prior to screening visit

 Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN

 Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia

 Known respiratory disorders other than COPD

 Patients who have clinically significant cardiovascular condition

['Chronic Obstructive Pulmonary Disease']


Thoracic Blocks Versus Thoracic Epidural and Patient Controlled Anesthesia in Traumatic Rib Fracture Patients

Summary: The primary objective of this study is to investigate whether continuous PVB is equal in efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs equal to or greater than 1.2.
Inclusion criteria: Eligibility Criteria

 A subject must meet the following criteria to take part in the study:

 inclusion criteria

 Subjects 18 years of age and greater

 Inpatient on the BWH SICU, MICU, or hospital floor ward

 Non-intubated at the time of block placement

 Traumatic Rib Fractures three or greater

 Block able to be placed within 12-24 hours of presentation to the emergency room

 Ability to provide written informed consent.

 Compliance with all ASRA and BWH Regional Anesthesia in Anticoagulated Patient guidelines for coagulation status.

Exclusion criteria: :

 Subject is pregnant

 Subject not expected to survive 48 hours due to traumatic injuries

 Allergy to Ropivacaine or other local anesthetic

 Any significant concomitant injuries potentially confounding data acquisition (e.g., traumatic brain injury, long bone fractures, intra-abdominal injuries)

 Known allergy to lidocaine

 Inability to provide written, informed consent

 Known opioid medication dependence

 Non-compliance with ARSA and BWH Regional Anesthesia in Anticoagulated Patient Guidelines.

['Paravertebral Block', 'Intercostal Nerve Block', 'Epidural Block']

Paravertebral Block
Intercostal Nerve Block
Epidural Block


Real-Time Instrument for Acetabular Shell Positioning

Summary: The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty.~The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments.~The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.
Inclusion criteria: inclusion criteria:

 Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:

 Primary, unilateral anterior or posterior total hip arthroplasty

 18 to 85 years old at time of surgery

 Able to get a pre- and post-operative CT scan at the Cleveland Clinic

Exclusion criteria: :

 Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.

 Pregnancy

 Incarceration

 Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

['Real-time Instrumentation', 'Standard Total Hip Arthroplasty']

Real-time Instrumentation
Standard Total Hip Arthroplasty


Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome

Summary: Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180 patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are expected to complete the study per protocol.~Study objectives:~Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for treatment of cyclic mastodynia and premenstrual syndrome.~To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic mastodynia.~Dose regimen:~Group 1: VAC BNO 1095 1x10 mg:~1 tablet of verum in the morning, 1 placebo tablet in the evening~Group 2: VAC BNO 1095 2x10 mg:~1 tablet of verum in the morning, 1 tablet of verum in the evening~Group 3: Placebo:~1 tablet placebo in the morning, 1 tablet placebo in the evening~The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening further visits are scheduled after the end of each of the first and second run-in cycle, and after the first, second and third treatment cycle, respectively.~Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of menstruation number n, with exception of the first screening visit which can be performed at any time prior to the first run-in cycle. Subsequently the time between the first study visit and the onset of the first run-in cycle menses T shall be added to the overall study duration.~In case that the next menstruation does not commence as expected, the patient should contact her investigator immediately in order to schedule a new appointment, approximately on the actual day 3 of the menses.
Inclusion criteria: inclusion criteria:

 Females aged 18 to 45 who have signed an Informed Consent Form (ICF) at screening visit S-2 (screening visit -2) at the latest.

 Subject has a history of cyclic mastodynia and premenstrual syndrome

 Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2.

 At screening visit S-2 subject is reporting at least one physical premenstrual syndrome symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list

 At screening visit S-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list

 In both run-in cycles:

 Visual analog scale greater or equal 50 mm at least on one of the days of the late luteal phase

 Cyclic course of the mastodynia, i.e. visual analog scale in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the visual analog scale in the late luteal phase (maximum value of 5 daily recordings)

 Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1)

 At least one physical premenstrual syndrome symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present

 Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 10 at day 4 of the menstruation

 Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 8 in the mid follicular phase (average of daily recordings documented on days 6 to 10)

 Note: Late luteal phase is defined as days -5 to -1 (5 days prior to the onset of menses) while mid follicular phase is defined as days 6 to 10 after the onset of menses.

Exclusion criteria: :

 Pre- Menstrual Dysphoric Disorder

 Intake of any of the following medications before treatment start (visit S-2 up to visit V0) and within 6 months prior to visit S-2:

 Any treatment for mastodynia or premenstrual complaints

 Sexual hormones, combinations and inhibitors

 Pituitary hormones and their inhibitors

 Hypothalamic hormones

 Neuroleptics, antidepressants

 Serotonin-re-uptake-inhibitors

 Prolactin-inhibitors or prolactin stimulating preparations

 Non Steroidal Anti-Inflammatory Drugs (NSAIDs) or any other analgetics including antirheumatics

 Spironolactone

 Androgens

 Gonadotrophin inhibitors

 Diuretics

 Danazol

 Psychotropic agents

['Cyclic Mastodynia', 'Premenstrual Syndrome']


Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales

Summary: This is a prospective, randomized, controlled cohort study. This study will look at the effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20 mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when compared to a control group using no hormonal contraception. Depressive symptoms and sexual function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W). Participants will begin taking the medication at Week 3 postpartum, and these outcomes will be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and increase in sexual function in both of the oral contraceptive groups.
Inclusion criteria: inclusion criteria:

 18-45 year old women who desire contraception postpartum for at least 6 weeks.

 18-45 year old women who choose not to use oral contraceptive medication postpartum for at least 6 weeks for the control group.

Exclusion criteria:  (Medication groups):

 Breastfeeding (although this may limit participant enrollment, combined oral contraceptives are contraindicated in this population).

 Delivery by cesarean section.

 Previous history of depression, mood disorders, or psychiatric disorders.

 Any condition (history or presence of) which contraindicates the use of combination OCs, including:

 Thrombophlebitis or thromboembolic disorders, known or suspected clotting disorders, deep vein thrombosis, thrombogenic valvulopathies or rhythm disorders.

 Pulmonary Embolism.

 Cerebrovascular or coronary artery disease or myocardial infarction.

 Diabetes mellitus.

 Migraine headaches with focal, neurological symptoms.

 Chronic renal disease.

 Uncontrolled or untreated hypertension.

 Cholestatic jaundice.

 Known or suspected carcinoma of the breast, endometrial carcinoma, or known or suspected estrogen-dependent neoplasia.

 Impaired liver function or disease, hepatic adenomas or carcinomas.

 Known hypersensitivity to estrogens and/or progestins.

 History of thyroid disorders.

 Recent alcohol or drug use.

 Smoking and age ≥35 or smokers who will become 35 years of age during the study.

 Known history of noncompliance with taking medication.

['Ethinyl Estradiol 35mcg/Norethindrone 1mg', 'Ethinyl Estradiol 20mcg/Norethindrone 1mg']

['Postpartum Depressive Mood', 'Postpartum Sexual Function']

Postpartum Depressive Mood
Postpartum Sexual Function


Assessment of Artesunate/Mefloquine in the Peruvian Amazon

Summary: There is growing evidence of the emergence of P. falciparum resistance to artesunate (a derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border.~The purpose of this research study, is to assess the in vitro and in vivo efficacy of combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia and other important outcomes.
Inclusion criteria: inclusion criteria:

 Age between 5 and 65 years old inclusive

 Monoinfection of P. falciparum confirmed by microscopy

 Documented fever (axillary temperature > 37.5°C) and/or history of fever during the previous 48 hours in the absence of other obvious causes of fever (such as pneumonia, otitis media, etc)

 Infection with P. falciparum of 1000 and 100,000 asexual parasites per microliter (μl) to be determined by microscopic examination of a thick or thin smear, and positive confirmation by polymerase chain reaction (PCR); * Presence of sexual form of P. vivax is acceptable; ** PCR confirmation is not an enrollment requirement

 Informed consent must be obtained from the participant or both parents/guardian (in the case of children), and assent from the child (from 8 to 17 years old)

 Willingness of the participant to return to the health facility for regular check-ups during the follow-up period of 42 days

 Willingness of the participant to transfer to the Hospital de Apoyo Iquitos to start treatment

Exclusion criteria: :

 Severe malaria signs (as defined by the World Health Organization):

 Cerebral malaria (irreversible coma)

 Severe anemia (hematocrit < 15%, or clinic signs)

 Clinic signs of kidney failure (e.g., serum creatinine > 3 mg/dL)

 Pulmonary edema

 Hypoglycemia (glucose in the blood <40mg/dL or clinic signs)

 Shock (PA systolic < 70 mm Hg in adults; < 50 in children)

 Spontaneous bleeding/Disseminated intravascular coagulation (CID)

 Recurrent generalized convulsions

 Acidemia/acidosis (clinic signs)

 Macroscopic hemoglobinuria

 Jaundice Laboratory tests for measuring some of these conditions may not be available at all study sites. If they are not, we will use clinical criteria of severe malaria at the discretion of the study physician

 Background of other chronic or severe diseases (e.g., heart, kidney, liver diseases, HIV/AIDS, severe malnutrition), determined clinically by medical history and physical examination

 Background of hypersensitivity to any of the drugs tested or used as an alternative treatment: AS, MQ, quinine or tetracycline/clindamycin

 Gestation (based on a serum pregnancy test or medical history) or desire to become pregnant during the study period, or not using any family planning method while being sexually active (confirmed by urine pregnancy test)

 Breastfeeding a child under 6 months old

 Have received antimalarial drugs in the previous 7 days

 Inability to eat or drink, vomiting (more than twice in the last 24 hours), recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand

 Splenectomy background