Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury

Summary: The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions.~Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research.~After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.
Inclusion criteria: inclusion criteria:

 Adults, age 18-70 years, both men and women

 Able to speak and read English as primary language

 Able and willing to provide written informed consent for study participation.

 Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol.

 Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure.

 Past history of at least one brain injury with persistent symptoms that meets all of the following criteria:

 Brain injury of non-stroke etiology that occurred at least 6 months but no more than 10 years prior to enrollment.

 At least 3 of the following persistent symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, depression, anxiety, post-traumatic stress, or ringing in the ears.

 Normal thyroid stimulating hormone and hematocrit value greater than 35% within the previous 6 months.

Exclusion criteria: :

 Contraindications to hyperbaric oxygen

 Insulin-dependent diabetes mellitus, or diabetes mellitus that is not reasonably controlled.

 Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months).

 Claustrophobia precluding chamber or hood tolerance.

 Implanted devices not cleared for hyperbaric pressurization.

 Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control during study participation.

 Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease that raises the risk for pulmonary barotrauma due to air trapping.

 Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal.

 Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygen.

 Confounds to the outcome assessments

 Inability to speak English as their primary language (English fluency required because many of the outcomes are only in available in English)

 Instability with walking requiring more than a cane for assistance

 Alcohol abuse, by self-report, within the last year.

 Lifetime history of illicit drug use, by self-report, except remote (greater than one year), non-habitual use of marijuana.

 Failed urine drug screen during study participation.

 Continued participation during the intervention period in sports activities where head injury is likely, such as contact football, boxing, mixed martial arts, etc.

 Blind or deaf.

 Major psychiatric disorder or degenerative mental disease (such as multiple sclerosis).

 Prior therapeutic radiation to the central nervous system.

 Personal history of any condition that pre-dates their brain injury that resulted in diminished capacity (such as chromosomal disorders) or that, in the opinion of the investigators, affects cognition to such a degree that the outcome assessments are invalidated (such as learning disability or attention deficit hyperactivity disorder requiring pharmaceutical therapy as an adult).

 Any brain injury from stroke (ischemic or hemorrhagic)

 Known untreated chronic or acute medical conditions, such as hypothyroidism, Cushing's disease, untreated hypertension, etc., that would confound the outcome assessments or inhibit compliance with the study protocol. If treated, these disorders would not be excluded.

 Concomitant enrollment in any other drug/device clinical trial.

 Prior hyperbaric oxygen for any reason within the last year.

['Hyperbaric Oxygen', 'Minimal pressure air']


Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial

Summary: The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.
Inclusion criteria: inclusion criteria:

 Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20 cm from the incisors) or gastroesophageal junction are included.

 No distant metastases (M0).

 Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon.

 Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.

 Resectable mediastinal nodes are eligible.

 No prior chemotherapy for this malignancy.

 No prior radiotherapy that would overlap the field(s) treated in this study.

 Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.

 Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.

Exclusion criteria: :

 Cancers of the cervical esophagus (< 20 cm are excluded).

 Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.

 Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.

 Patients with biopsy proven metastatic celiac nodes are ineligible.

['Preoperative treatment of chemotherapy and radiation', 'Postoperative treatment of chemotherapy and radiation']


Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

Summary: The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.
Inclusion criteria: inclusion criteria:

 Age > 18 years

 Informed consent

 ART naive

Exclusion criteria: :

 No informed consent

 History of ART use

 Pregnancy

['Immune Reconstitution Inflammatory Syndrome', 'Opportunistic Infections']


Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions

Summary: The overall purpose of this project is to determine the feasibility of conducting a large scale randomized clinical trial that compares remote monitoring of adherence to loop diuretics using a wireless electronic pillcap with usual care among recently hospitalized heart failure patients. The long-term goal of this program of research is to determine the effect of the adherence telemonitoring intervention on medication adherence and hospital readmissions among recently hospitalized heart failure patients.
Inclusion criteria: inclusion criteria:

 Hospitalized for heart failure

 Prescribed loop diuretic medication at discharge

Exclusion criteria: :

 Age less than 21 years

 New York Heart Association Class IV heart failure

 Terminal illness (<6 mo prognosis)

 Unable to self-administer medications due to mental illness or cognitive impairment

 Non-English/Spanish speaking

 Discharged to an institutional setting (e.g., nursing home)

 Cardiologist or primary care provider refusal

 Unavailable for follow-up

 No access to telephone

 Enrolled in another cardiac trial


Adapted and Translated, Adolescent Depression, Internet Intervention

Summary: Objectives :~The key objective of this study is to develop new interventions that addresses the diverse needs and circumstances of Hong Kong adolescents with depressive symptoms in community settings. Collaboration between medical professionals and social workers may prevent the occurrence of depression and misguided attempts to self-treat with alcohol and / or drugs in our adolescents.~Methods :~To address this intervention gap in the United States, Dr. Van Voorhees, a research collaborator of Dr. Chim and Dr. Ip, developed and conducted a phase 2 clinical trial of a primary care internet-based depression prevention intervention (CATCH-IT, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal training). It has been observed clinically that the strategy could reduce depressed mood, increased social support and reduced depressive episodes at 12 month follow-up.~The investigators now propose to study if an adaptation of the CATCH-IT website for Hong Kong Chinese adolescents may lead to significant reductions in depressed mood. In this pilot trial, the investigators propose to test the efficacy of the Adapted and Translated version of CATCH-IT (AT-CATCH) against the placebo approach in preventing the onset of depressive episodes in a group of adolescents (aged 13-17) who have depressive symptoms, but have not developed depression yet.The case group will have access to the AT-CATCH website while the control group will only be allow to use the anti-smoking website.~The investigators hypothesize that compared to youth in the control group, youth assigned to the AT-CATCH group will have a lower hazard ratio of major depressive episodes and decreased alcohol / drug use frequency over 2 years. Moreover, compared to youth in the control group, youth in the AT-CATCH program will demonstrate a steeper slope of improved symptoms through growth curve analysis and fewer depressed days over the study period.
Inclusion criteria: inclusion criteria:

 age 13 to 21

 experience a moderately elevated level of depressive symptoms on the CES-D scale (score 16-34)

 may or may not have had a past history of depression, anxiety and/or substance abuse

Exclusion criteria: :

 currently diagnosed with depression, schizophrenia, or bipolar affective disorder ;

 currently taking antidepressants or psychotropic medication ;

 CES-D score equal or higher than 35, or a proved serious medical illness that causes significant disability or dysfunction ;

 exhibit significant reading impairment, mental retardation, developmental disabilities

 serious imminent suicidal risk or other conditions that may require immediate psychiatric hospitalization

 have extreme, current drug / alcohol abuse (greater than or equal to 2 on the CRAFFT)


Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth

Summary: Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences.~Sleeping on the back during pregnancy has recently emerged in scientific literature as a potential risk factor for SB and LBW. In fact, one of the earliest studies to demonstrate this link was conducted in Ghana by investigators on this protocol.~When a woman in mid-to-late-pregnancy lies on her back, her large uterus compresses one of the major veins that delivers blood back to her heart and may completely obstruct it. This may result in less blood being returned to her heart and less blood being pumped to her developing fetus. Such changes may negatively impact the growth of her fetus and, along with some other risk factors, may contribute to the death of her baby.~The investigators have developed a device, 'PrenaBelt', to significantly reduce the amount of time a pregnant woman spends sleeping on her back. The PrenaBelt functions via a simple, safe, effective, and well-established modality called positional therapy.~The purpose of this study is to determine the effect of the PrenaBelt on birth-weight and assess the feasibility of introducing it to Ghanaian third-trimester pregnant women in their home setting via an antenatal care clinic and local health-care staff. Data from this study will be used in effect size calculations for the design of a large-scale, epidemiological study targeted at reducing LBW and SB in Ghana and globally.
Inclusion criteria: inclusion criteria:

 ≥18 years old

 low-risk singleton pregnancy

 entering the last trimester of pregnancy (in range 26-30 weeks of gestation)

 residing in the Greater Accra Metropolitan Area or area served by the Korle Bu Teaching Hospital

 fluent in either English, Twi, or Ga.

Exclusion criteria: :

 BMI ≥ 35 at booking (first antenatal appointment for current pregnancy)

 pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth])

 sleep complicated by medical conditions (known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder])

 multiple pregnancy

 known fetal abnormality

 maternal age >35

['PrenaBelt', 'Body Position Sensor', 'sham-PrenaBelt']

PrenaBelt
Body Position Sensor
sham-PrenaBelt

['Sleep', 'Pregnancy', 'Stillbirth', 'Infant, Low Birth Weight', 'Infant, Small for Gestational Age', 'Infant, Very Low Birth Weight', 'Fetal Growth Retardation', 'Fetal Hypoxia']

Sleep
Pregnancy
Stillbirth
Infant
Low Birth Weight
Infant
Small for Gestational Age
Infant
Very Low Birth Weight
Fetal Growth Retardation
Fetal Hypoxia


Florbetapir Calibration to the Centiloid Scale

Summary: This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
Inclusion criteria: inclusion criteria:

 Cognitively Normal Subjects

 Males or females ≥ 21 and ≤ 45 years of age

 Mini-mental state examination (MMSE) ≥ 29

 Clinically Diagnosed AD Subject

 Males or females ≥ 50 years of age

 Meet clinical criteria for dementia due to probable AD

 MMSE ≥ 16 and ≤ 26

 Possible AD Subject

 Males or females ≥ 50 years of age

 Meet clinical criteria for dementia due to possible AD

 MMSE ≥ 16 and ≤ 26

 MCI Subject

 Males or females ≥ 60 years of age with cognitive impairment (not dementia)

 MMSE >24 and <29

 At Risk Elderly Subject

 Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age

 MMSE ≥ 27

Exclusion criteria: :

 Have had or currently have a diagnosis of neurodegenerative disorders other than AD

 Have a current serious or unstable illness that could interfere with completion of the study

 Subject has a known brain lesion, pathology or traumatic brain injury

 Have received or participated in a trial with investigational medications in the past 30 days

 Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session

 Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception


Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma

Summary: To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines 2011.
Inclusion criteria: Inclusion:

 Written informed consent

 Adolescents aged 12-17 years & adults aged 18-65 years (both inclusive)

 Documented clinical history of severe asthma requiring prednisone/prednisolone therapy, high-intensity treatment ICS, OCS, LABA

 Stable OCS dose for ≥7 days before Screening Visit & during Screening Period.

 At least 80% compliant w/regular asthma medication per investigator at end of Screening Period

 Documented asthma reversibility within 5 yrs prior to/during Screening Period, or diagnosis of asthma that is incontrovertible per investigator

 Ability to use nDPI correctly, per investigator's review of completed inhaler operation checklist

 Ability to use eDiary correctly, assessed by investigator at end of Screening Period

 Ability to comply w/study procedures, including blood sampling

 Ability to perform technically satisfactory pulmonary function tests

 Available to complete all study visits before 12 noon

 BMI of 16-26 kg/m2 in adolescents and 18-32 kg/m2 in adults

 Oral PIF ≥40 L/min, using an appropriate device set to match resistance of inhaler

 Good health, except for presence of asthma, per medical history/physical examination

 Negative drug/alcohol/urine cotinine screen. Subjects must test negative for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, ethanol & opiates (unless given as prescription medicine)

 Non-smokers or ex-smokers with a smoking history of less than 10 pack-yrs (e.g. <20 cigarettes per day for 10 years or <40 cigarettes per day for 5 years) & stopped smoking for at least 1 year prior to Screening Visit. Smoking will not be permitted throughout study

 Female subjects of child-bearing potential must be using medically acceptable forms of contraception [abstinence, hormonal (oral/implant/transdermal/injection), in use for ≥3 consecutive months before first dose of study medication, double barrier (condom w/spermicide, or diaphragm w/spermicide), IUD, or vasectomised partner (≥6 months since vasectomy)].

 Exclusion:

 Regular use (≥3 times/wk) of topical steroids to treat dermatitis/rhinitis/allergic conjunctivitis, within 28 days of Screening Visit

 Subjects who have/who have had, an upper/lower respiratory tract infection within 28 days of Screening Visit

 Subjects w/brittle asthma

 Subjects w/asthma that required admission to an ICU and/or ventilation within previous 12 months

 Subjects whose comorbidities, per investigator's opinion, are major contributors to their respiratory symptoms (e.g. COPD, bronchiectasis, dysfunctional breathlessness, vocal cord dysfunction, gastro-oesophageal reflux)

 Previously/currently diagnosed as having Churg-Strauss syndrome

 Previously/currently diagnosed as having pulmonary eosinophilia

 History of lung cancer

 Subjects w/current diagnosis of HIV infection

 Active chronic hepatitis B or C infection

 Subjects who have clinically significant abnormality/finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment

 Subjects with an abnormal ECG

 Persistent arterial hypotension, with average SBP readings of ≤95 mmHg

 Persistent elevation of blood pressure, with average SBP readings of ≥160 mmHg or average DBP readings of ≥100 mmHg

 Pregnant or lactating females

 Participation in another clinical study in 28 days prior to Screening Visit

 Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrectable hypokalaemia, or predisposition to low levels of serum potassium

 Current/history of drug/alcohol abuse/dependence per WHO criteria

 Inability to communicate well w/investigator

 Donation of ≥450 mL of blood/blood products within previous 3 months prior to screening

 History of allergy/intolerance/contraindications to corticosteroids/lactose, or severe allergy to milk proteins

 Consumption of alcohol- or caffeine-containing foods/beverages from midnight before or during Screening Visit

 History of medically diagnosed chronic respiratory diseases other than asthma (e.g. chronic obstructive pulmonary disease, ABPA in the absence of asthma)
Exclusion criteria:


Catheter Thrombectomy in Patients With Massive Pulmonary Embolism

Summary: Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism~Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F.~Treatment: Aspirex 11F assisted thrombectomy~_________~The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device.~_________~Primary Endpoints:~Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP).~The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures.~Secondary Endpoints:~Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index.~There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels.~In-hospital mortality will not exceed 20%.~Study Design: A prospective international multicenter non-randomized registry assessing the safety and efficacy of the Aspirex 11F mechanical thrombectomy device.~Sample Size: Maximum of 50 patients~Inclusion Criteria:~Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis or at least contraindication for lysis.~Exclusion Criteria:~Systemic embolism in the presence of an arterial septal defect or patent foramen ovale.~Free floating right heart thrombi, left heart thrombi.~Life expectancy, due to underlying disease, less than one month.
Inclusion criteria: inclusion criteria:

 Patients >= 18 years of age with pulmonary embolism and cardiogenic shock, defined as a systolic arterial pressure <= 90 mmHg, a drop in systolic arterial pressure >= 40 mmHg for >= 15 minutes, or ongoing administration of catecholamines for systemic arterial hypotension

 Subtotal or total filling defect in the left and/or right main pulmonary artery due to massive PE, as assessed by chest computed tomography or by conventional pulmonary angiography

 Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional)

 Failed thrombolysis or at least one of the following contraindications to PE thrombolysis present:

 Active bleeding

 History of intracranial bleeding

 Surgery, delivery, organ biopsy, puncture of a non-compressible vessel within 10 days

 History of stroke

 Gastrointestinal bleeding within 10 days

 Significant trauma within 15 days

 Head injury requiring hospitalization within 1 year

 Active cancer with known hemorrhagic risk

 Neurosurgery or ophthalmologic surgery within the past year

 Platelets < 50,000 or INR >2.0

 Pregnancy

Exclusion criteria:

 Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale

 Free floating right heart thrombi, left heart thrombi

 Life expectancy due to underlying disease less than one month


The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy

Summary: The immediate postoperative period after tonsillectomy, , is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Opioid consumption may be reduced by non-steroidal anti-inflammatory drugs, but these drugs may be associated with increased bleeding after this operation.~Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy. Study drugs were marked only with a coded number label. A computer-generated table of numbers guided randomization. Modified Hannallah pain scale [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were interviewed on the day after surgery to assess the postoperative pain, nightmares, hallucinations, vomiting and bleeding. All the children were premedicated with midazolam hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with thiopental 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique for all cases and hemostasis done with bipolar cutter. At the end of the surgery neuromuscular blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg intravenously), anesthesia was discontinued and the tracheal tube removed in the operating room when patients were deep. After extubation the patients were taken to the postanesthesia care unit (PACU) where an nurse who were unaware of the study drug observed the patients. The pain scoring observer nurse in PACU was consistent. Time to awaken (from the end of anesthesia until the patients opened their eyes on command) and time to the first administration of postoperative analgesia were recorded. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients with a OPS score > 4 or who were crying during two consecutive five minute observation periods until the child was comfortable. Postoperative pain during the first 24 h was assessed using a four-point scale: 0 no pain, 1 mild pain, 2 moderate pain, 3 severe pain by questioning their parents. In the ward the standardized postoperative analgesic technique was with acetaminophen supp (40 mg/kg followed by three doses of 20 mg/kg at 6-hour intervals to be given as needed for pain. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients who had pain scale >3.Any supplementary analgesia , nausea and vomiting, bleeding, sleep disturbance and nightmares that the child might have had as surgery were assessed during a telephone follow up 24 h later.
Inclusion criteria: inclusion criteria:

 children age 3-12 years ASAI,II

Exclusion criteria: :

 contraindication for usage of Ketamine, dexamethasone

 upper respiratory tract infection

 increase intracranial pressure( ICP)

 history of allergy ,seizure,psychiatric illness, , bleeding disorders

 chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery,

 history of peritonsillar abscess, , tonsillitis within two weeks, -

['saline', 'Ketamine', 'Dexamethasone', 'ketamine-dexamethasone']

saline Ketamine Dexamethasone ketamine-dexamethasone


Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction

Summary: Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid dysfunction
Inclusion criteria: inclusion criteria:

 patients with subclinical hypothyroidism or hyperthyroidism

 patients with thyroid nodules and normal thyroid function

Exclusion criteria: :

 patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone

 patients who had thyroid surgery or radioiodine therapy

 patients with NYHA class 3 or 4 heart failure

['Subclinical Hypothyroidism', 'Hyperthyroidism', 'Thyroid Dysfunction']

Subclinical Hypothyroidism
Hyperthyroidism
Thyroid Dysfunction


Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia

Summary: The objective of this clinical study is to evaluate the influence of the Great autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular system in patients with resistant hypertension. The primary endpoint is the change in mean blood pressure after 10 treatments .~In addition, data are collected on the immune system as well as for food and sleep quality.
Inclusion criteria: inclusion criteria:

 Resistant Hypertension > 140 / > 90mmHg

 Inclusion age : 45 +

 Regular monitoring of blood levels considered

 pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent

 Men and Women

Exclusion criteria: :

 derailed diabetes

 renal impairment , renal creatinine clear <50 ml

 Non - austherapierte cancer / tumor patients

 Non - adjusted thyroid dysfunction

 BMI> 35

 LVEF <limit (  35%  )

 Peripheral AVK ( ABI - measurement ) > Stage II

 regurgitation > Stage I

 abdominal aneurysm

 infections

 acute febrile infections with temperature > 38.5 ° C

 COPD and asthma to stage III

 dyspnea NYHA > Stage III

 z.n. Stroke shorter than 12 weeks

 Acute liver failure

 Acute Apoplexy

 Severe poisoning

 drug addiction

 hyperthyroidism

 Hypotension

 hypocalcemia

 hypoglycemia

 ozone allergy

 pregnancy

 clotting problems ( hemophilia )

 pre-existing condition with hemoglobin < 9mg/dl

 Fresh myocardial infarction

 Internal bleeding

 thrombocytopenia

 Acute alcohol

 Citrus allergy when using sodium citrate


Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy

Summary: Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.
Inclusion criteria: inclusion criteria:

 Maternal age 20-35 years old.

 Singleton pregnancy between 16 - 24 weeks.

 Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study.

Exclusion criteria: :

 Extremes of reproductive age (less than 20 years old or more than 35 years old).

 Patients with multiple pregnancies.

 Anemia not linked to iron deficiency.

 Allergy to iron derivatives.

 Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.

 Those who had received parenteral iron treatment earlier within 3 months before the start of the study.

 Any obstetric complicating factors like pregnancy induced hypertension.

 Patients with history of chronic blood loss.

['Theragran Hematinic', 'low molecular weight iron dextran']

Theragran Hematinic
low molecular weight iron dextran

['Treatment of Iron Deficiency Anemia in Pregnancy']


Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

Summary: We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.
Inclusion criteria: inclusion criteria:

 The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis.

 The patient is willing to take nothing by mouth including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat.

Exclusion criteria: :

 The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication.

 The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit.

['Celecoxib', 'Celecoxib', 'celecoxib', 'placebo']


Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica

Summary: The aim of this study is to evaluate a simple and rapid method in order to better define and treat Polymyalgia Rheumatica by measuring levels of muscle achiness and pain with a blood pressure cuff.
Inclusion criteria: inclusion criteria:

 Patients signing Informed Consent

Exclusion criteria: :

 Patients less than 50 years old

['Polymyalgia Rheumatica', 'Rheumatoid Arthritis', 'Rheumatic Disease']

Polymyalgia Rheumatica
Rheumatoid Arthritis
Rheumatic Disease


Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease

Summary: This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.
Inclusion criteria: inclusion criteria:

 Subjects with peripheral arterial disease for more than 6 months.

 Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease.

 Over 40 years old

 Able to comply with protocol requirements

 Able to provide informed consent

 Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study.

 Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study.

Exclusion criteria: :

 Patients with ischemic rest pain in limbs, ulceration, or gangrene.

 At baseline, any condition that prevents walking on a treadmill.

 History of major bleeding.

 Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis).

 Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures).

 Moderate to severe renal failure.

 Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study.

 Fish limitations (no more than 2 fish meals per week)

 Gluten allergy

 Subjects with allergies to any ingredient in the study product or placebo.

 Patients who plan to undergo surgery during the course of the trial.


Removable Walker for Neuropathic Ulcers

Summary: Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer~Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.
Inclusion criteria: inclusion criteria:

 The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND

 The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts.

Exclusion criteria: :

 Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot,

 Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage,

 The probe-to-bone maneuver was required to be negative,

 Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis,

 Use of steroids or cytostatic drugs,

 Presence of sensory, motor, or visual problems that could impair functional autonomy,

 Active ulcer on the contralateral foot,

 Previous major amputation of the contralateral limb,

 Previous or current deep venous leg thrombosis, OR

 Mental disorders interfering with patient compliance.


Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

Summary: Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke as a means of excluding AF. Small studies indicate that extending the duration of monitoring with portable outpatient telemetry devices detects more cases of AF. However, these studies are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring detects more cases of AF than routine clinical follow-up. The investigators therefore propose a pilot study to determine the feasibility of randomizing patients to prolonged cardiac monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult patients seen at the University of California at San Francisco (UCSF) Neurovascular service with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event monitor for 21 days. Group B will be discharged home without a monitor and will serve as controls during routine clinical follow-up. The investigators' primary outcome will be feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1 year.
Inclusion criteria: inclusion criteria:

 Age > 18 years

 Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA

 Onset of stroke or TIA symptoms within the previous 60 days

Exclusion criteria: :

 Definite small-vessel etiology by history or imaging

 Source found on vascular imaging of possible culprit vessels

 Source found by echocardiography (TEE not required)

 History of atrial fibrillation

 Atrial fibrillation on admission ECG

 Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required)

 Obvious culpable systemic illness such as endocarditis

 Patient unable to provide written, informed consent

['Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)']


Cardiovascular Health Study (CHS)

Summary: To determine the extent to which known risk factors predict coronary heart disease and stroke in the elderly, to assess the precipitants of coronary heart disease and stroke in the elderly, and to identify the predictors of mortality and functional impairments in clinical coronary disease or stroke.
Inclusion criteria: Eligible participants were sampled from Medicare eligibility lists in each area. Those eligible included all persons living in the household of each individual sampled from the Health Care Financing Administration (HCFA) sampling frame, who were 65 years or older at the time of examination, were noninstitutionalized, were expected to remain in the area for the next three years, and were able to give informed consent and did not require a proxy respondent at baseline. Potentially eligible individuals who were wheelchair-bound in the home at baseline or were receiving hospice treatment, radiation therapy or chemotherapy for cancer were excluded.
Exclusion criteria:

['Heart Diseases', 'Cardiovascular Diseases', 'Coronary Disease', 'Cerebrovascular Accident', 'Diabetes Mellitus', 'Hypertension', 'Heart Failure, Congestive']

Heart Diseases
Cardiovascular Diseases
Coronary Disease
Cerebrovascular Accident
Diabetes Mellitus
Hypertension
Heart Failure
Congestive


The Benefit and Harm of Fever Suppression by Antipyretics in Influenza

Summary: The purpose of this study is to investigate the potential benefits and risks of antipyretics use in naturally occurring influenza virus infections in humans.
Inclusion criteria: inclusion criteria:

 Adults aged between 18-30

 Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature ≥37.8°C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) within 48 hours of illness onset

 being tested positive with a QuickVue rapid influenza test

Exclusion criteria: :

 Allergic to paracetamol or any other antipyretics

 Have any underlying immunocompromized condition or be receiving immunosuppressive agents.

 Have any history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication.

['Paracetamol', 'Placebo', 'Backup NSAID ibuprofen']

Paracetamol
Placebo
Backup NSAID ibuprofen


Creatine Treatment for Female Adolescents With Depression Who Are Non-Responders to Fluoxetine or Escitalopram

Summary: The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. Creatine may have effects of interest in the brain. The reason for the MRI component of this study is to learn about new ways to see inside the brain. The investigators will use magnetic fields and radio waves to look at the brain and chemicals in the brain. The investigators hope that this technique will have medial use in the future.~The primary hypothesis of the study is that oral creatine supplementation will have a beneficial effect as adjunctive therapy in female adolescents with MDD who are non-responders to an adequate trial of the SSRIs Fluoxetine or Escitalopram.
Inclusion criteria: inclusion criteria for Major Depressive Disorder Participants:

 Participants must meet DSM-IV-TR criteria for Major Depressive Disorder, with current mood state depressed for ≥ 2 weeks.

 Participants must be females

 Participants must be between the age of 13 and 18 years.

 Participants must have had an adequate trial of fluoxetine, defined as a trial of ≥ 8 weeks of treatment, with a dose of ≥ 40mg daily for ≥ 4 weeks. If the participant had a trial of 40mg daily and was unable to tolerate it, a dose of 20mg for ≥ 8 weeks is acceptable; OR

 Participants must have had an adequate trial of escitalopram, defined as a trial of ≥ 8 weeks of treatment, with a dose of ≥ 20 mg daily for ≥ 4 weeks. If the participant had a trial of 20 mg daily and was unable to tolerate it, a dose of 10 mg for ≥ 8 weeks is acceptable.

 Participants must have a CDRS-R score of ≥ 40 and a CGI-S score of ≥ 4.

 Participants must be able to give informed consent or assent, and where applicable, parent(s)/guardian(s) must be able to give informed permission for study participation.

 inclusion criteria for Healthy Control Participants:

 Participants must be females

 Participants must be between the age of 13 and 18 years.

 Participants must not meet DSM-IV-TR diagnostic criteria for a psychiatric or substance abuse disorder.

 Participants must be able to give informed consent or assent and, where applicable, parent(s)/guardian(s) must be able to give informed permission for study participation.

Exclusion criteria:  for Treatment-Resistant Major Depressive Disorder Participants:

 Unstable co-morbid medical, neurological or psychiatric disorder.

 Pre-existing renal disease.

 Proteinuria or microalbuminuria.

 Pregnant females, nursing mothers, or females of childbearing potential who are unable or unwilling to practice birth control during the study. Participants who are of child-bearing potential must have a negative urine pregnancy test before each MRI/MRS brain scan.

 High risk for suicidal behavior, homicidal behavior or self-harm.

 Adolescents who are unlikely to be able to comply with the study protocol.

 DSM-IV-TR criteria for current substance abuse or substance dependence, with the exception of nicotine abuse or dependence.

 Contraindication to MRI/MRS brain scans, such as ferromagnetic implants or claustrophobic anxiety.

 Documented or suspected history of intellectual disability (Full-Scale I.Q. < 70).

 History of hypersensitivity to creatine monohydrate.


Osteoprosis in Type 2 Diabetic Patients- a Cohort Study

Summary: Some possible humoural and cellular mechanism for diabetes related osteoporosis/fractures were proposed and summarzied as the following, (1)Diabetes mellitus increases osteoclast function but decreases osteoblast function, thereby leading to accelerated bone loss, osteopenia and osteoporosis. (2)DM/hyperglycemia induces production of macrophage colony stimulating factor (MCSF), tumor necrosis factor (TNF)-α and receptor activator of nuclear factor-κB ligand (RANKL), all of which are osteoblast-derived activators of osteoclast proliferation and differentiation. (3) DM/hyperglycemia suppresses osteoblast proliferation and function, in part, by decreasing runtrelated transcription factor (Runx)-2, osteocalcin and osteopontin expressions. (4)Adipogenic differentiation of mesenchymal stem cells is increased as indicated by the overexpression of adipocyte differentiation markers, including peroxisome proliferator-activated receptor (PPAR)-g, adipocyte fatty acid binding protein (aP2), adipsin and resistin. A decrease in neovascularization may further aggravate bone loss. (5)Bone quality is also reduced as a result of advanced glycation end products (AGE) production, which may eventually result in low impact or fragility fractures. DM are associated osteoporosis/fracture. The underlying mechanism, especially of type 2 DM, mandates a DM-osteoporosis cohort to elucidate. In clinical practice, to developed preventive strategies from osteoporotic-fracture is also necessary.
Inclusion criteria: inclusion:40-99 years old with type 2 DM patient

 exclusion:organization people
Exclusion criteria:

['Type 2 Diabetes Mellitus', 'Osteoporosis']


Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis

Summary: Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers volunteers could improve clinical parameters when compared to metronidazole tablets + periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly assigned into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal debridement combined with daily topical application of 3 g metronidazole benzoate gel (15%); and periodontal debridement combined with a daily single dose of 750 mg metronidazole. Clinical parameters evaluated were visible plaque, gingival bleeding, probing pocket depth and relative attachment level.
Inclusion criteria: inclusion criteria:

 diagnosis of chronic periodontitis

 presence of at least 6 periodontal pockets with a clinical attachment loss of ≥5 mm

 bleeding on probing (BOP)

 radiographic bone loss

 probing pocket depth higher or equal to 5 mm in at least six teeth

 at least 20 teeth in mouth (third molars excluded)

 an established smoking habit (at least 10 cigarettes per day for the past 4 years)

Exclusion criteria: :

 periapical alterations in qualifying teeth

 medical disorders requiring prophylactic antibiotic therapy or interfering with the treatment

 periodontal treatment in the past 6 months

 use of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) within the past 6 months

 orthodontic therapy

 pregnancy and lactation

 allergy to metronidazole

 any systemic diseases (e.g.: diabetes and immunological disorders)

['Full-mouth periodontal debridement', 'Metronidazole tablet', 'placebo gel', 'Metronidazole benzoate gel']

Full-mouth periodontal debridement
Metronidazole tablet
placebo gel
Metronidazole benzoate gel


EVA: Evista Alendronate Comparison

Summary: The purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures
Inclusion criteria: inclusion criteria

 50-80 years of age, inclusive

 2 years since last menses

 Dx femoral neck osteoporosis

 No vertebral fractures

Exclusion criteria:

 Poor candidate for study drugs

 Hx of diseases affecting bone metabolism

 Hx of breast/estrogen-dependent cancer

 Current use of osteoporosis drug therapy

 Hx/high risk of VTE


Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness

Summary: The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.
Inclusion criteria: Inclusions Criteria:

 written informed consent/assent is obtained

 meet minimal criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for narcolepsy (or presumed narcolepsy) or OSAHS OR have a previous diagnosis of narcolepsy or OSAHS before the screening visit

 have a complaint of ES

 are in good health as determined by a medical and psychiatric history, physical examination, ECG, and clinical laboratory tests

 have blood pressure values greater than those for the 5th percentile and less than the 95th percentile on the National High Blood Pressure Education Program guidelines for blood pressure levels for boys and girls ages 6 to 16 years

 girls who are postmenarchal or sexually active, have a negative urine pregnancy test at screening, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 2 cycles after participation in the study); acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptives (oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence

 able to swallow a tablet similar in size and shape to the study drug tablet

 negative urine drug screen (UDS) for any illicit drug, alcohol (ethanol), stimulants at screening; if positive for stimulants (prescribed for excessive sleepiness) at screening, UDS to be repeated after a washout period and before baseline

 have a parent or legal representative who is willing to participate in the study

Exclusion criteria: :

 have self-induced sleep deprivation/poor sleep hygiene

 have a past or present seizure disorder (except history of single febrile seizure), a history of psychosis, or of clinically significant head trauma (eg, brain damage) or past neurosurgery

 have a history of suicide attempt, or are at suicidal risk

 a clinically significant drug sensitivity to stimulants such as amfetamine, dexamfetamine, or methylphenidate; and/or modafinil or any of its components

 use of any monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRIs) within 2 weeks of the baseline visit (NOTE: SSRIs will be allowed for cataplexy if the patient has been on a stable dose for at least 1 month.)

 received any investigational drug (except modafinil) within 4 weeks of the baseline visit

 any disorder that could interfere with drug absorption, distribution, metabolism, or excretion (including previous gastrointestinal surgery)

 active, clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other major clinically significant disorder/disease

 any clinically significant deviation from the normal range(s) in the physical examination or ECG findings, or clinical laboratory test results (ie, serum chemistry, hematology) at the screening or baseline visit

 absolute neutrophil count (ANC) below the lower limit of normal at screening (NOTE: If the ANC is below the lower limit of normal at the baseline visit, the medical monitor will be consulted for continued eligibility in the study.)

 a history of alcohol, narcotic, or any other substance abuse

 pregnant or lactating/nursing girl


Dental Support Device During Breastfeeding as a Mean for Pain Control

Summary: Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.~This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Inclusion criteria: inclusion criteria:

 Maternal age 18-45 years.

 Normal vital signs.

Exclusion criteria: :

 Contraindications for breastfeeding.

 Significant systemic disease that cause pain or require chronic pain relief.


Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer

Summary: Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.
Inclusion criteria: inclusion criteria:

 We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.

Exclusion criteria: :

 1.serious disease 2.refuse informed consent


Posterior Compression Distraction Reduction （CDR）Technique in the Treatment of BI-AAD

Summary: Posterior compression - distraction reduction technique （CDR） in the treatment of Basilar invagination associated with atlantoaxial dislocation
Inclusion criteria: inclusion criteria:

 Age between 18-70

 Patients with cervical CT display that atlanto occipital fusion or partial fusion, Atlantoodontoid interval(ADI)>>3mm, odontoid tip over Qian line(CL)>>3mm.

 Agreed to the surgical operation treatment

 The patient can carry out clinical follow-up and agree to long-term clinical follow-up

 Signed informed consent

Exclusion criteria: :

 Patients with traumatic atlanto-axial dislocation

 Patients with rheumatoid atlantoaxial dislocation

 Patients with a history of occipital cervical junction operation

 Patients with severe cerebellar tonsillar hernia (reach the C2 margin), needed to remove tonsil of cerebellum

 Patients during pregnancy and the postpartum period within 3 months

 The life expectancy of < 1 years

 Severe dementia(MMSE<18)

 Severe renal failure (CR > 2.5mg/dl)

 Serious cardiovascular disease (such as unstable angina, heart failure)

 Atrial fibrillation and other severe arrhythmia

 Without the ability to sign the informed consent

['Posterior Approach Compression Distraction Reduction']

['Basilar Invagination Associated With Atlantoaxial Dislocation']


Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients

Summary: The goal of this research study is to look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop tools to help predict the likelihood of lung cancer occurrence in this population. This will be done by studying characteristics of tissue and bodily fluids (including blood).~Objectives:~To assess the smoking-related disease-free survival in patients who are current or former smokers with a prior definitively-treated stage I/II lung or head and neck cancer.~To develop a risk model to help predict the likelihood of lung cancer development both imaging and biomarker based in this high-risk population.
Inclusion criteria: inclusion criteria:

 Patients with either: a) histologically proven stage I, II, IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).

 HNSCC patients:Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment.

 No evidence residual cancer

 Age > = 18 years

 Performance status of 0- 2 (Zubrod)

 Patients must have no contraindications for undergoing bronchoscopy.

 Patients must have no active pulmonary infections.

 Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg %.

 Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.

 All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (b) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (c) side effects and health risks may occur, as described in the informed consent form.

 Smoking history of at least 10 pack years. May be current or former smoker.

 Subject must be considered legally capable of providing his or her own consent for participation in this study.

 HNSCC patients only: Must have no contraindications for undergoing laryngoscopy.

Exclusion criteria: :

 History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.

 History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.

 Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required).

 Participants with active pulmonary infections or recent history of pulmonary infection (within one month).

 Participants with acute intercurrent illness.

 Participants requiring chronic ongoing treatment with NSAIDs except aspirin.

 Participants with history of stroke, uncontrolled hypertension, and/or uncontrolled angina pectoris.

 Patients may not take high dose antioxidants (vitamins E or C) during the study period. High dose will be determined by the study investigators.

 Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day). High dose is defined as anything greater than a once-daily multivitamin. Any additional supplementation will be evaluated at the discretion of the treating physician.

 History of biologic therapy.


Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED)

Summary: To evaluate the sensitivity and specificity of two major, widely used technologies, radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the diagnosis of pulmonary embolism.
Inclusion criteria: Men and women suspected of having a pulmonary embolism and who met the criteria to undergo angiography.
Exclusion criteria:


Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

Summary: It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.
Inclusion criteria: inclusion criteria:

 Female or male inpatients.

 Age: 18-80 years.

 If female, patient must not be pregnant

 Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage.

 Onset of symptoms within 3 hours prior to initiation of rt-PA administration.

 Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure or migraine disorder.

 Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country.

 Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtful that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. A written consent has to be obtained as soon as possible.

 Willingness and ability to comply with the protocol.

Exclusion criteria: :

 Evidence of intracranial haemorrhage (ICH) on the CT-scan

 Violation of inclusion criteria not approved by clinical study director or study safety officer

 Failure to perform or to evaluate screening or baseline examinations

 Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period

 Participation in another therapeutic clinical trial 3 months before baseline

 Patients with any history of prior stroke and concomitant diabetes

 Prior stroke within the last 3 months

 Platelet count of below 100x103/mm3

 Blood glucose <50 or >400 mg/dl (<2.77 or >22.15 mmol/L)

 Known haemorrhagic diathesis

 Manifest or recent severe or dangerous bleeding

 Known bacterial endocarditis, pericarditis

 Acute pancreatitis

 Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformation

 Neoplasm with increased bleeding risk

 Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal varices) and active hepatitis

 Major surgery or significant trauma in past 3 months

 Lab values seriously abnormal, and/or more than 2 lab values abnormal not approved by clinical study director or study safety officer

 Serious drug allergies

 Hypersensitivity to one of the components of the drug

 Severe renal impairment

 Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits

 Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture)

 Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs, alcohol or industrial poisons

 Symptoms of ischemic attack began more than 3 hours prior to start of thrombolytic therapy or if time of symptom onset is unknown

 Minor neurological deficit or symptoms rapidly improving before start of infusion

 Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate imaging techniques

 Epilepsy or epileptic seizure at onset of stroke

 Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal

 Known history of or suspected intracranial haemorrhage

 Suspected subarachnoid haemorrhage or condition after subarachnoid hemorrhage from aneurysm

 Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)

 Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)

 Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory

 Patients receiving oral anticoagulants, e.g. warfarin sodium

 Special attention should be given to possible additive effects when used in conjunction with anti-depressants or MAO-inhibitors

 Cerebrolysin should not be mixed with balanced amino acid solutions in an infusion

['Cerebrolysin', '0.9% Saline Solution']


Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs

Summary: This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility and acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence support; and assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT and unobserved dosing interventions, and identify key factors affecting treatment adherence.
Inclusion criteria: inclusion criteria:

 ≥18 years of age;

 2 consecutive positive HCV RNA tests at least 6 months after estimated date of infection;

 HCV genotype 1;

 HCV RNA <6 million copies by Roche TaqMan Assay

 No evidence of hepatic cirrhosis (as determined by two indices: Fib4<3.25-an accurate test for detecting cirrhosis based on age, AST, ALT and platelets [sensitivity/specificity 76-100/82-91%], confirmed by the fibrosis-cirrhosis index (FCI)<1.25 based on ALT, bilirubin, albumin and platelets [sensitivity/specificity 86/100%]);

 Drug injection in past 30 days by self-report and physical exam evidence of injection drug use (e.g. track marks),

 injected with others in past 12 months by self-report;

 Lab values within acceptable range (platelets>50,000, creatinine clearance by Cockroft-Gault>30mL/min, hemoglobin >10g/dL, INR<1.5 x upper limit of normal (ULN) unless stable on anticoagulant regimen or known hemophilia, AST/ALT<10 x ULN);

 Able to speak English;

 No plans to leave San Francisco area for at least 9 months and either lives or works in San Francisco, or travels to San Francisco at least weekly;

 for women of childbearing age, pregnancy test negative, not actively nursing, and agree to use birth control during treatment (although LDV-SOF has a B rating, consistent with no known evidence of harm, treatment is not urgent for these patients so we will err on the side of caution).

Exclusion criteria: :

 HIV+ by rapid test or pooled viral load;

 HBV surface antigen +;

 Non-definitive HCV genotype results;

 Previously received treatment for HCV (interferon, ribavirin, or DAA);

 Taking medications that affect pharmacokinetics of LDV-SOF (proton-pump inhibitors, anticonvulsants [phenobarbital, phenytoin, carbamazepine, oxcarbazepine], rifamycins, rosuvastatin, herbs [St. John's wort, silymarin, echinacea]);

 History of any of the following:

 Current gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug

 History of hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)

 History of solid organ or bone marrow transplantation.

 Current treatment for cancer

 Chronic liver disease for non HCV reason, except iron overload (e.g., Wilson's disease, alfa 1 antitrypsin deficiency, cholangitis);

 Use of any prohibited concomitant medications as described in Section 5.2 within 21 days of the Day 1 visit; and

 Known hypersensitivity to LDV, SOF, the metabolites, or formulation excipients.

 No other conditions that preclude study involvement as determined by PI.

['modified directly observed therapy (mDOT)', 'unobserved dosing', 'Motivational Interviewing-based counseling']


Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty

Summary: The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.
Inclusion criteria: inclusion criteria:

 Subject must be ≥ 18 years of age

 Subject must, at the treating physician's determination and definition, be an appropriate Candidate for primary total hip or knee arthroplasty

 Subjects who undergo primary total knee or hip arthroplasty must have a linear or semi-linear incision whose length and curvature should fit within the dimensions bound by the polyurethane foam (10 inches in length by 2.5 inches in width)

 Subject is able and willing to provide written informed consent and comply with visit schedule

 Subject must agree to avoid application of tanning lotions or exposure of ultraviolet radiation from sun or artificial sources such as a tanning bed on operative area for the duration of study participation

 Subject must not be pregnant if of child-bearing potential, or otherwise must be surgically sterilized or unable to conceive. All females, regardless of child-bearing potential, will receive a urine hCG test 2 weeks prior to surgery and the test result must be negative for pregnancy.

 Subjects who are of child-bearing potential must be utilizing an acceptable method of birth control (eg, birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) and be willing to continue birth control for duration of study participation. If birth control method is the form of birth control pills, shots, implants skin patches, or IUD, the method must have been utilized for at least 30 days prior to study participation.

 Subject must be willing to wear loose fitting clothing for duration of treatment period

 Subject must be willing to comply with visit schedule for the duration of the study

Exclusion criteria: :

 Positive pregnancy test confirmed by hCG in urine

 Current or past (30 days prior to surgery) within time of screening attempts to become pregnant

 Current local or systemic infection (eg, skin infections, sinus infections, urinary tract infection, sepsis, etc)

 Current or past (14 days prior to surgery) within time of screening topical treatments on operative area (eg, laser hair or tattoo removal, sunless tanning lotions)

 Current or past (14 days prior to surgery) steroid topical therapies on operative area

 Current or past (30 days prior to surgery) use of oral steroids (NOTE: Use of non-topical, ophthalmic or aerosol types of steroids (ie, inhaled corticosteroids) are permitted at screening and throughout the clinical trial)

 Current or past (72 hours prior to surgery) within surgery use of antihistamines

 Current or past (30 days prior to surgery) within time of screening use of oral Tetracycline or AcutaneTM or topical Tetracycline or AcutaneTM on the operative area

 Presence of skin lesions or abnormalities on operative area

 Current or past malignancy requiring immunosuppressant therapy or chemotherapy within 5 years within time of screening

 Presence of excessive skin folds on operative area

 Intentional exposure of the operative area to ultraviolet radiation (14 days prior to surgery) within time of screening (ie, sunbathing or tanning bed)

 Presence of sunburned or peeling skin on operative area

 Tattoos on operative area

 Presence of severe, raised scar tissue on operative area which may interfere with pre and post skin evaluation assessments

 Presence of an open wound prior to the index surgical procedure on operative area

 Reported alcohol (≥ 3 drinks per day) or drug abuse within the past 6 months

 Topical hypersensitivity or allergy to any disposable components of the dressing system (eg, silver, polyurethane, polyester, or acrylic adhesive)

 Topical hypersensitivity or allergy towards any medical adhesive

 Current enrollment or past participation in this clinical study or any other study within ≤30 days

 Any systemic or local active dermatological disease that might interfere with the evaluation of the operative area (eg, Meleney's ulcer, scleroderma, chronic urticaria, psoriasis, skin cancer, eczema, seborrhea, or malignancy)

 Connective tissue disease or collagen vascular disease (eg, Ehlers-Danlos syndrome, systemic lupus erythematosus, rheumatoid arthritis)

 Current or history of hematological disorders or conditions (eg, polycythemia vera, thrombocythemia, sickle-cell disease)

 Any Subject with conditions which can potentially result in abnormally pigmented skin (eg, melasma, vitiligo, pityriasis versicolor)

 Inability or refusal to wear loose fitting clothing for the duration of the treatment period

 Subjects in whom orthopaedic reconstruction is required in addition to total hip or knee arthroplasty

 Subjects who are having the total hip or knee arthroplasty as a result of acute orthopaedic trauma

 Subjects who have incurred acute orthopaedic trauma (ie, hip fracture) recently or at any time

 Subjects who have either acute or chronic open/active wounds present (including biopsies, ulcerations, etc)

 Subjects in whom the index procedure is a revision of a total hip or knee arthroplasty

 Subjects in whom the primary or partial total hip or knee arthroplasty would also be performed on the contra lateral knee or hip at the same time

['Prevena Incisional Management System']

['Linear or Emi-linear Incisions', 'Total Hip Arthroplasty', 'Total Knee Arthroplasty']

Linear or Emi-linear Incisions
Total Hip Arthroplasty
Total Knee Arthroplasty


Improving Hand Use in Multiple Sclerosis

Summary: This study will compare two different kinds of physical therapy to improve use of the hands in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced Movement therapy (CI therapy), the other will be a set of Complementary and Alternative Medicine (CAM) treatments (yoga, relaxation exercises, aquatherapy, massage). The study will determine which of the two forms of treatment is more successful for improving hand use.
Inclusion criteria: inclusion criteria:

 diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS)

 reduced use of one of the hands because of MS

 ability to pick up and release a small object with the more-affected hand when requested

 can travel to the treatment program at the University of Alabama at Birmingham (UAB)

 can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day

 can undergo MRI scan

 any kind of medication used for MS is allowed except spasticity medicine

Exclusion criteria: :

 disease relapse in the past 3 months

 pregnancy

 marked pain with arm movement

 severe uncontrolled medical illness

 simultaneous treatment with another form of physical therapy


Prevalence of Malignant and Premalignant Lesions in the Head & Neck in Patients With Chronic Obstructive Pulmonary Disease

Summary: Head and neck cancers usually occur in patients who have a history of long tobacco use. Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways and lung parenchyma that is also associated with exposure to tobacco. COPD and head & neck cancer share a common environmental risk factor in cigarette smoke exposure. the investigators hypothesize that patients with chronic lung disease related to smoking have a higher risk to develop cancer in the head and neck.~The investigators designed a study to assess the prevalence of cancer and pre-cancer disease in the head & neck in patients with chronic lung disease. the investigators will examine patients with and without a history of smoking and chronic lung disease in order to determine the prevalence of head and neck cancer in the different groups. The patients who will be included in the study will undergo comprehensive evaluation of their lung function and voice performance.~This study is a joint effort of the Pulmonology Institute and the Department of Otolaryngology, Head & Neck Surgery in Israel and the Netherlands.
Inclusion criteria: inclusion criteria:

 group of adult COPD patients.

 Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic.

 Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine

Exclusion criteria: :

 Patients with an acute disease or COPD exacerbation

 Pregnant patients

 Patients who were intubated ≤3 months prior to inclusion

 Patients with a medical history of surgical intervention in the upper airway

 Patients with a medical history of malignant disease in the upper airway

 Patients who underwent radiotherapy of head and neck

['Stroboscopic nasopharyngeal laryngoscopy', 'Stroboscopic nasopharyngeal laryngoscopy', 'Stroboscopic nasopharyngeal laryngoscopy']


Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

Summary: The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.
Inclusion criteria: inclusion criteria:

 Subjects must provide informed consent

 Men or women aged 18 years or more

 Ongoing cancer disease recent diagnosis of veinous thromboembolism treatment with Low Molecular Weight Heparin before entry into the study

Exclusion criteria: :

 - Contraindication to the use of Low Molecular Weight Heparin


Vitamin D's Effect on Physical Performance in the Elderly

Summary: The purpose of this study is to compare vitamin D deficient and vitamin D sufficient elderly individuals and examine the effect of a vitamin D dietary supplement on serum vitamin D level, bone formation, resorption, and mineral density, flexibility, balance, general inflammation,and quality of life. Enhancing nutritional status is necessary to prevent the continued proliferation of chronic diseases, e.g., bone disease and other chronic disorders thought to now be related to low levels of vitamin D, which are some of the leading disablers and killers of Americans. Americans also have difficulties with compliance to prescription medications due to their toxicity and side effects. This study aims to learn more about how a vitamin D nutritional supplement may improve nutritional status and enable the body to normalize system functioning,which may improve the quality of life for people with vitamin D deficiency. The results of this research will be used to determine if vitamin D is beneficial for overall health among elderly individuals.
Inclusion criteria: inclusion criteria:

 Men and women ages 55 years and over

 English or Spanish speaking

 Interest in participating in a novel nutritional supplement program

 Willingness to follow recommendations, including going off of all vitamin-D and calcium containing supplements, multivitamins, or OTC medications (e.g., Tums) 2 weeks before starting the study and during the intervention

 Scoring 0-2 errors on the Short Portable Mental Status Questionnaire

Exclusion criteria: :

 Less than 55 years of age

 Currently enrolled in another research trial for vitamin D dietary supplements or other bone disease treatments

 Unable to consent to the study

 Living in a skilled or intermediate care level nursing facility

 Women who are pregnant, during their period, or less than 2 days before or after their period at the time of the assessment

 Psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence

 Bleeding disorders

 Aphasia or sensory, motor, and/or visual disturbances that could interfere with assessments, including inability to walk 10 feet without a walking aid

 Gastrointestinal disorders that could lead to uncertain resorption of the study supplements

 Major conditions such as neurologic, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint that could interfere with vitamin D metabolism, psychometric tests, or body composition assessment (especially renal and heart failure)

 Erratic, accelerated, or mechanically-controlled irregular heart rhythms, atrial fibrillation/flutter, or atrioventricular block or implanted electronic device

 Any condition restricting blood flow, such as severe systemic vascular resistance

 Acute fever, diarrhea, or edema at the time of the assessment

 Dermatological lesions or excessive hair that would be in contact with the placement of the electrodes for the ESC assessment

 Hematologic or oncologic disorders treated with chemotherapy in the previous two years

 Dysfunctional levels of hemoglobins like carboxyhemoglobin or methemoglobin

 Active chemotherapy or radiation treatment for cancer

 Recent infusion of dyes into the bloodstream such as methylene blue, indocyanine green, indigo carmine, or fluorescein

 Diagnosis of a terminal illness

 Persons may not be in the second part of the study while participating in another trial for drugs, supplements, or treatment that affects serum vitamin D level

 Persons may not be in the second part of the study if they are unwilling to go off all vitamin D and calcium containing supplements, multivitamins, and over the counter medications 2 weeks prior to starting the study and for the duration of the second part of the study

 Persons may not be in this study if they are unwilling to have their blood drawn

 Persons may not be in the second part of the study if they are taking steroids, HCTZ, or any other drug known to interfere with vitamin D metabolism or taking diuretics or any other drug that interferes with hydration status

 Persons may not be in this study if they are unwilling to refrain from alcohol, caffeine, and stimulants (amphetamines) 12 hours before the examination

 Persons may not be in this study if they are unwilling to stop physical activity or sauna use 8 hours before the examination

 Persons may not be in this study if they are unwilling to remove fingernail polish or false fingernails during the testing


Feasibility Study of Cryotherapy for Chronic Venous Disorders

Summary: Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treated disorders shat harm the veins of the legs and at worst, cause skin inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVDs and that the intervention will become a standard of care for CVDs. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.
Inclusion criteria: inclusion criteria:

 Aged 45 years and older

 CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers)

 Ankle brachial index (ABI) 0.9 - 1.3mm Hg 0 absence of peripheral arterial disease

 Intact skin sensation measured with 10 gram monofilament

 Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces

 Agreement to wear compression garments such as wraps or stockings during waking hours

 Phone, e-mail, or mail accessible

 Working freezer

Exclusion criteria: :

 ABI < 0.8 mm Hg or > 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature)

 Active systemic or localized infections such as cellulitis (raises skin temperature)

 Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon

 Body temperature > 37.6 degrees C (febrile state raises skin temperature)

 CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing)

 Known peroneal nerve injury

 Impaired skin sensation

 Unable to detect light touch measured with a 10 gram monofilament at lower leg skin surfaces

 Unable to detect not/cold sensation measured with thermal sensory tester at lower leg skin surfaces

 Not wearing compression or not agreeing to wear compression wraps or stockings

 Phone, e-mail, or mail inaccessible

 No working freezer


Assessment of MDD Management in Andalusia

Summary: The main objectives of this study are to describe medical professionals responsible of the management of patients with MDD in a representative region of Andalusia (in terms of type of sites managing the disease, and referral to SC criteria); Describe MDD patient characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated to a higher incidence of referral from PC to SC.
Inclusion criteria: inclusion criteria:

 MDD Diagnosis Participants of the PismaEP study 18 yo. or older

Exclusion criteria: :

 No specific


Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon

Summary: This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.
Inclusion criteria: inclusion criteria:

 Acute rupture of the achilles tendon (on one or both sides)

 Older than 18 year of age

 Firmed letter of approval

 Patient speaks/understands German

 Planed surgical treatment

 No more than 48h after rupture

Exclusion criteria: :

 No-traumatic rupture of the achilles tendon

 More than 48h after rupture

 No planed surgical treatment

 History of surgery on the injured leg

 Condition of diabetes mellitus

 Condition of peripheral artery occlusive disease

['Stitches', 'Fibrin-glue', 'Stitches and Fibrin-glue']

Stitches
Fibrin-glue
Stitches and Fibrin-glue

['Microcirculation', 'Achilles Tendon Rupture']

Microcirculation
Achilles Tendon Rupture


Ischaemic PReconditioning In Non Cardiac surgEry

Summary: Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.~Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote organ or vascular territory provides protection from injury by myocardial ischemia and reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the first proof of principle and small randomized controlled trials have shown a decreased release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into better survival in a recent randomized trial performed in cardiac surgery. No clinical trial on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.~The investigators study wants to test, for the first time, the hypothesis that remote ischaemic preconditioning is effective in reducing cardiac damage in high risk patients undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5 minutes reperfusion while the cuff will be deflated. General anesthesia will be induced and maintained without using propofol in both groups. Cardiac troponin will be used as marker of cardiac damage. If the results of a reduction in postoperative cardiac troponin release and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery setting, the investigators could improve a strategy to prevent perioperative cardiac complication easy to apply, safe and low cost.
Inclusion criteria: inclusion criteria:

 written informed consent

 intermedial and high risk non cardiac surgery

 general anesthesia

 ongoing or recently suspended antiplatelet therapy

Exclusion criteria: :

 pregnancy

 planned locoregional anesthesia without general anesthesia

 unstable or ongoing angina

 recent (< 1 month) or ongoing acute myocardial infarction

 inclusion in other randomised controlled studies in the previous 30 days

 peripheral vascular disease affecting the upper limbs

 cardiac surgery

['Remote ischemic preconditioning', 'no ischemic preconditioning']

Remote ischemic preconditioning
no ischemic preconditioning


Gene Therapy for Painful Diabetic Neuropathy

Summary: The purpose of this study is to assess the safety and tolerability of injecting VM202 in the leg muscle in patients with painful diabetic neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with DPN.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years to 75 years

 Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of ≤ 10.0%)

 Diagnosis of painful diabetic peripheral neuropathy in both lower extremities

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

 Visual analog scale (VAS) score of ≥ 4 cm at Screening (0 cm = no pain - 10 cm worst imaginable pain)

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

 Lower extremity pain for at least 6 months

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

Exclusion criteria: :

 Peripheral neuropathy caused by condition other than diabetes;

 Other pain more severe than neuropathic pain;

 Progressive or degenerative neurological disorder;

 Myopathy;

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

 Active infection;

 Chronic inflammatory disease (e.g. Crohn's, Rheumatoid Arthritis)

 Positive HIV or HTLV at Screening

 Positive Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAB), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV), at Screening or known immunosuppression or on chronic treatment with immunosuppressive drugs, chemotherapy or radiation therapy

 Stroke or myocardial infarction within last 6 months;

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

 Cataract surgery within 6 months of trial;

 Vascular lesions of the anterior segment of the eye (infection or ulceration of the cornea, rubeotic glaucoma, etc);

 Vascular lesions of the posterior segment of the eye or proliferative retinopathy, macular edema, s/p photocoagulation for macular edema or proliferative retinopathy; sickle cell retinopathy, ischemic retinopathy due to retinal venous stasis or carotid artery disease;

 Choroidal angiogenesis; and

 Large elevated choroidal nevi, choroidal vascular tumors (choroidal hemangioma), or melanomas.

 Specific laboratory values at Screening including: Hemoglobin < 9.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, Creatinine > 2.0 mg/dL; GFR < 50, AST and/or ALT > 2 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary;

 Use of gamma-linolenic acid (GLA), alpha lipoic acid or any other high dose dietary antioxidant supplement for symptomatic relief of DPN;

 Uncontrolled hypertension as defined as sustained systolic blood pressure (SBP) > 200 mmHg or diastolic BP (DBP) > 110 mmHg at baseline/screening evaluation;

 Patients with history of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence);

 Malignant tumors or abnormal screening test suspicious for cancer, or patients in whom screening exams indicate possible occult malignancy unless malignancy has been ruled out. Patients with family history of colon cancer in any first degree relative unless they have undergone a colonoscopy in the last 12 months with negative findings;

 Elevated PSA unless prostate cancer has been excluded;

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

 Major psychiatric disorder in past 6 months;

 History of drug or alcohol abuse / dependence in the past 2 years;

 History of recent tobacco abuse (within past 5 years);

 BMI > 38 kg/m2;

 Use of an investigational drug or treatment in past 12 months; and

 Unable or unwilling to give informed consent.


Prevention of Weight Gain in Early Psychoses

Summary: The purpose of this study is to determine whether individuals with psychotic spectrum disorders ( Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II),Major Depressive Disorder With Psychotic Features,Substance-Induced Psychoses,Psychosis Not-Otherwise-Specified (NOS)randomly assigned to a stepped behavioral intervention for the prevention of weight gain will experience less weight gain than individuals who receive usual care. There are several studies that have examined the effect of pharmacological and non-pharmacological behavioural approaches for weight loss in patients with psychosis, however studies examining strategies for prevention of obesity are lacking. This study is an important and novel approach to studying the problem of obesity in those with psychosis.
Inclusion criteria: inclusion criteria:

 Age between 14 and 45 years (inclusive)

 Male or Female gender

 DSM-IV-TR diagnosis of Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II), Major Depressive Disorder With Psychotic Features, Substance-Induced Psychoses, Psychosis Not-Otherwise-Specified (NOS)

 Outpatient status at the time of randomization

 Duration of antipsychotic treatment of less than 5 years

 Ability to provide informed consent

 Female patients of childbearing potential must be using a medically accepted means of contraception

 Treatment with olanzapine, clozapine, quetiapine,risperidone or paliperidone for less than 8 weeks duration at enrollment

 BMI between 18.5 and 30

Exclusion criteria: :

 Inability to give informed consent

 Currently enrolled in a weight management program

 Currently being treated with a medication to reduce weight

 Patients with unstable or active cardiovascular illnesses (myocardial infarction, congestive heart failure, etc), active or end-stage renal disease, and unstable thyroid disease, etc

 Inclusion/

['Behavioural Intervention for the Prevention of Weight Gain', 'TAU']

['Schizophreniform Disorder', 'Bipolar I Disorder', 'Bipolar II Disorder', 'Major Depressive Disorder', 'Substance-Induced Psychoses', 'Psychosis Not Otherwise Specified', 'Schizophrenia', 'Schizoaffective Disorder']

Schizophreniform Disorder
Bipolar I Disorder
Bipolar II Disorder
Major Depressive Disorder
Substance-Induced Psychoses
Psychosis Not Otherwise Specified
Schizophrenia
Schizoaffective Disorder


Lung Cancer Location: a Repository

Summary: The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.
Inclusion criteria: inclusion criteria:

 Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer

 Subjects with a prior history of lung cancer

 Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer

Exclusion criteria: :

 Altered mental status that would prohibit the giving and understanding of informed consent

 Dementia

 Psychiatric illness that would preclude adequate compliance with communication for this protocol

 Prisoners