text: The colour scale shows a total of 5 colours. The area marked "E"shows an area with estimated current equivalent dose rate of 10 mSv/h (in a 25x25 km2 square). The violet colour on the outer edge of contaminated areas (Area A) represents 0,3 μSv/h, which corresponds to the amount of the natural background radiation dose.


text: Ben Frye | IBDB: The official source for Broadway Information IBDB: The official source for Broadway Information Official Broadway League sites: - sites - broadway.org broadwayleague.com broadwayfanclub.com kidsnightonbroadway.com stagespecs.org tonyawards.com Quick Search For: In This Category: All Show People/Org. Theatre Season Ben Frye Producer Male Productions ProductionsDate of ProductionsThe Garden of Sweets[Play, Original] Produced by Ben Frye Oct 31, 1961 - Oct 31, 1961Christine[Musical, Original]Associate Produced by Ben Frye Apr 28, 1960 - May 08, 1960 Find out where Ben Frye and are credited together © 2001-2015, The Broadway League, All Rights Reserved. (Copyright and Disclaimer)

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A view taken on February 20, 2013 shows the Pontiff's gardens by the... News PhotoApostolic Palace,Castel Gandolfo,Horizontal,International Landmark,Italy,Pope,ReligionPhotographer FILIPPO MONTEFORTECollection: AFP 2013 AFPA view taken on February 20, 2013 shows the Pontiff's gardens by the Apostolic Palace of Castel Gandolfo, Italy. Pope Benedict XVI will stay at the Vatican's summer residence from February 28 until the convent of Mater Ecclesiae (Mother of the Church) at the Vatican will be ready to host him. Pope Benedict XVI began a week-long spiritual retreat out of the public eye on February 18 ahead of his resignation on February 28 with the field of candidates to succeed him still wide open. AFP PHOTO / FILIPPO MONTEFORTE (Photo credit should read FILIPPO MONTEFORTE/AFP/Getty Images)


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A California woman will be reunited with her 1970 class ring after it was lost about 6 years ago, according to Maui police.
On Sunday, Maui police officer Ka Lae O Ka Ena Brown met with a Wailuku woman who found the ring.
Brown was told that the ring was found in the dirt on Kahawai Street in front of her residence.
The ring was found about six months ago and the woman had initially listed the ring on Craigslist in an attempt to return the ring to its rightful owner. After no response, the woman turned the ring over to police.
The class ring is a Jostens women's ring with St. Mary of the Wasatch written on the ring along with the year 1970, a blue stone, and the initials "JM" engraved on the inside of the ring.
Brown found that the ring came from the school formerly known as St. Mary of the Wasatch in Utah. It was an all-girls school and later turned into a college.
Brown contacted the school and found out that there was a student with the initials "JM" that belonged to its 1970 graduating class. That student's name was Jane McGill.
McGill is now known as Jane Razzeca and lives in California. Razzeca said she visited Maaui about six years ago when her daughter got married in Wailea, but did not recall bringing the ring on the trip. But, she had lost track of the ring many years ago.
On Thursday, Maui police told Razzeca the class ring will be returned to her. Razzeca said she was ecstatic that her class ring was found after all these years and very happy that Officer Brown went out of her way to return the ring.
Brown was recommended for a commendation by her supervisor.
"We are very proud of Officer Brown, who epitomizes the 'Spirit' of professional policing for the Maui Police Department and the 'Caring Nature' of the people of Hawaii," said Maui Police Chief Gary Yabuta.


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http://www.geargrams.com/list?id=10903This is my gear list so far for a CT thru-hike this summer. I'll (hopefully) be leaving at the end of August and plan on finishing in 22 days or less due to time constraints. If it turns out that I have more time than that, I'll go a bit slower and enjoy it...and if I have less time than that, I'll take a shuttle to Breckenridge and start there in order to cut around 100 miles off.Some thoughts:Shelter -- I'm planning on using a MLD Grace Solo Spinn tarp in tandem with a TiGoat Ptarmigan bivy (with netted hood) on the trip. I bought the tarp just a few weeks ago and have never used one before, but am not averse to the open-ness that drives some people away from tarps. I'm not sure if I need a groundsheet or not...would the bivy be fine without one? I want one primarily so that I can put my pack and gear on it instead of on the ground. If it turns out that I don't like the tarp (testing it in two weeks or so) then I'll just bring my Tarptent Moment which would add just under a pound to my pack weight.Pack -- the GG Murmur should really be all I need for the trip. I have no problem fitting my gear in it, and really like how light it is. If all else fails, I do have a GoLite Jam or ULA CDT to fall back on.Bag -- even though it's technically a 1+ season bag, I've taken it down to the mid-20s with the proper clothing and stayed comfortably warm. It packs down great and I like the center zip feature.Clothing -- I love the montbell UL down parka. The EMS power-dry shirt is a great mid-layer, and the REI baselayer top is long-sleeved to help prevent sunscreen. The EMS tights are also very comfortable and light. I'm slightly undecided about rain gear, though. I don't care if my legs get wet, but I'm not sure if I need a dedicated rain top or not. I currently have a montbell UL wind shirt as a dual-use wind/rain shirt, but considering how much rain there is on the CT I might bring a GoLite Virga (6oz I think)...any suggestions?Also, I'll probably be wearing different shoes than those listed...just don't know which ones yet.
Edited by nsiderbam on 01/03/2013 23:15:26 MST.
Looks like a pretty good list here are a few thoughts (I did the trail up to Molas Pass in 2011 and finished Molas to Durango this year)Rain Gear - I used a Golite Virga and for the amount of rain I encountered I consider it the bare minimum. I also had a pair of rain pants and I used them a lot. It can be very windy up there and having your legs wet and exposed to a wind is not fun. I would carry a rain skirt at minimum but I preferred the pants. This is especially important since it looks like most of your insulation is down. Pack - The Murmer looks like a nice pack but you have some pretty long sections between resupplies and some dry sections between water sources where you will be carrying a lot more weight (and remember you will be eating more on the last half of the trip so you'll want more like 2+ pounds of food per day instead of 1.5). You might need a more substantial pack. If you can travel fast enough and get your baseweight to 8 pounds or so maybe. Tarp - I did a large part of the trail with a MYOG 5x9 ft. tarp. It was adequate if a bit cramped. The Grace Tarp will be better because it has a bit more headroom. I think a tent would be overkill because bugs were never an issue and I did most of my camping at low elevations out of the wind. Bivy - I used a bivy and liked it on the trail. Bugs were never a problem Pad - There ought to be something lighter then that.Water Storage - I carried a lot more then 2 liters of water at times. I'd be ready to carry 3 or 4. Eric the Black's Guide - My friend shared one of these with me and I liked it a lot. The only problem is Eric is way to optimistic in what he lists as a "reliable" water source. The CT data book is much more realistic (remember August will be the driest time of year). I'd get the data book and make notes from it in Eric's guidebook.
I see a 4oz bottle for alcohol. Not sure how much you will use a day. 1oz minimum. Given the length re-supply points in the San Juans I would think you want more like an 8oz bottle or consider carrying some Esbit as a backup.
At the end of August, there won't be any bugs. The nights will also be cold - like lower 20's. Yes, there is a LOT of wind. Fortunately, the monsoon season will be winding down, but it will rain so dedicated rain gear - top and bottom - is a wise investment. Up high, that can be a very cold rain.I would suggest you:1- add a pair of dedicated merino wool sleeping socks. Your feet will love the clean dry covering and your sleeping bag will smell nicer too.2- add a pair of merino wool or synthetic glove liners. Your fingers will love you. A pair of WP overmitts will be a welcome addition for rain and wind.3- add a wide brimmed hat. The sun is quite intense above treeline and sunglasses alone won't cut it.4- you only have two platypus bladders of unknown size. You'll need more capacity than that on some sections south of Salida. I carried 3 one liter bladders (one on my Hoser system and two spares) and one wide-mouth one liter juice bottle (for water being treated). Platy bladders are very hard to fill from a stream. The empty one liter bladders cans stay rolled up in your pack until needed. 5- your REI trekking poles are 19 ounces. If you can afford it, consider the Gossamer Gear LT4 carbon fiber poles - 8 ounces the pair. I've used them on the PCT and CT for years. 6- I'd replace the mini-groundhog stakes with the full size versions, at least for the front and rear guylines. It's very windy above treeline and your tarp will need all the anchor it can get. Tent or tarp is purely a personal choice, but if you tarp, make it large enough to give you and your gear good coverage from the adternoon rain storms; they can be intense.You're starting from Breckenridge to save time, so you'll ultimately have to return to finish the first 6 segments anyway. That said, consider one of the two following scenarios: If you're interested in the map and logistical details, PM me with your email address and I'll forward it to you.1) Start from Copper Mountain Resort in segment 8 instead. The trail runs right behind the Burning Stone Plaza at the resort. 2) start from Breck (Gold Hill TH) as planned, but slack-pack segment 7 and that God-awful hill between Breck and Copper Mtn. Take the free bus from the Passage Point stop at Copper Mtn back to Breck to retrieve your gear, stay at the hostel overnight, return to CM the next day and hike on.Regards,WB
Edited by wandering_bob on 01/04/2013 13:42:33 MST.
The Murmur isn't the right pack for this trip (I've owned a couple and they are nice UL packs). Your base weight is 9 lbs and you will at times have a total pack weight of well over 20 lbs with food and water. Suggest you use one of your other packs. GG recommends 15 lbs max total weight. I would worry about seams ripping. Plus it gets really uncomfortable for me at 15+ lbs.Definitely need some real rain gear. Can't speak to your Virga. I would take my Marmot Essence or probably a poncho. It gets windy, so I use a cord to tie around my waist. You may be doing a lot of hiking in rain at times.I have a Montbell UL Wind Shirt. Don't know if you have used it a lot, but mine is a sauna. When I brought it on trips, I would only use it when it was an absolute necessity or crisis. I now have a Houdini and it is one of my favorite pieces of gear. Recommend both a wind shirt and rain jacket as two items. I second Luke on some sort of rain bottom. You might get biting cold, wind driven rain. Usually a rain skirt works for me, but I have only used one on just a few trips -- not a lot of experience.You don't "need" a ground sheet with a bivy, but you hit it on the nail -- nice for organizing things. I keep small items on mine at night. Look at some polycro, nice and light. I have several from GG.The Grace Solo will be fine, but make sure you match it with a bivy. Do you have the right weight? I think < 6 ounces would be a cuben tarp; you listed spinnaker. I have a GG Spinn Twin tarp and it is close to 11 ounces with guylines.I don't see glove liners or waterproof mitts. I would definitely take some. The Rockies can and will throw all kinds of weather at you; even in summer.I would take a merino wool cap or similar.A Caldera Cone GVP would be lighter than all your pieces (caddy not needed, the cone fits into the Foster's Keg). Plus I find very efficient. Very little fiddle factor for me.Enjoy your trip.
So...@Luke:I'll add the dedicated rain jacket. I'm going to see if I can find an old pair of montbell Versalite rain pants, or something along those lines. I'll also add a 1-liter gatorade bottle in there for some more water capacity. I could get a lighter pad, but that would cost me too much just to save 4 ounces. If I can find a good deal I'll snag one.@Randy:Thanks for catching that. I added an extra 8oz of fuel, but might end up carrying more.@Bob:I added the extra pair of socks. I knew that I needed some gloves, but wasn't sure which. Do you have any suggestions? I've heard good things about the MLD eVent gloves. I don't mind heavy trekking poles as they're in my hands and I like how durable the pair I have is. I also have 5 full-size groundhog stakes -- I just didn't list them in the list (it'll actually be 3 mini groundhogs and 5 full-size groundhog stakes).@Nick:I haven't had a chance to use the montbell windshirt yet, but I'll try it out before I go on the trip. If the lack of breathability isn't manageable, then I'll give in and pick up a Houdini. I'm not entirely sure on the weight of the tarp as I don't have a scale, but I know it's somewhere between what's listed and 8oz. The buff will be plenty warm for me (I love how versatile it is). On a final note, I'm really happy with the cooking setup I haven now -- the Fosters pot is great and I use the caldera caddy as a bowl/mug to eat and drink food or mixed drinks out of.I'm going to to try to lighten my load a little bit and see if the Murmur will work for me. If it doesn't, I'll just move up to the Jam (or maybe the new REI Flash 45 that's coming out -- preordered it two weeks ago).
Pad - Well if you want a full length pad then yeah keep what you have. On the other hand I've been perfectly happy with a short Prolite, which is lighter and cheaper then a longer one. Campmor has them right now for only $40, its 11oz.Pack - I had not heard of the Flash 45 pack but I'm liking what I see. I think the frame will be worth the weight. If your hike is like mine (dry so I often carried two liters of water or more) you'll top 20 pounds quit often. The pockets look nice too. You can save a LOT of time by having a well organized pack that you don't have to open up during the day.
You can get military surplus wool glove liners for under $10. Add a pair of MLD eEvent mitts and you'll be fine.
Apparently alcohol stoves are currently banned on the CT, or at the very least there is a large amount of confusion among all the park officials. I'll be doing this trip with my brother and we will be sharing a shelter and other items, so I don't mind using a heavier canister stove like the pocket rocket.Also, updated the gear list a bit:http://www.geargrams.com/list?id=10903
Looks good so far.1. I would still argue for a pair of rain pants, I would have been pretty unhappy on my hike without them. Now I did have a lot of rain. Apparently the monsoon season didn't end on schedule so I had numerous days where I'd be hiking in drizzle most of the day. It will be a bit cooler in late August so getting wet is more annoying then in the summer. 2. If I was really pinching grams I'd bring a smaller shelter but since you aren't I think the Trail Star will be nice. If you've been hiking in the rain all afternoon its really nice to have a roomy shelter to spread out in. 3. I'm not sure two batteries will be enough (mine drained a lot faster when it was cold and its a really pretty trail). Do you have a plan to charge them?4. Any updates on the REI pack? If it carries weight well that will be the pack I've always wanted REI to make.
If I was really pinching grams I'd bring a smaller shelter but since you aren't I think the Trail Star will be nice. If you've been hiking in the rain all afternoon its really nice to have a roomy shelter to spread out in. -------------------------He will be sharing with his brother, so I would say it is a good choice.
I'm planning on bringing rainpants -- just need snag some first off of gear swap. Also, I think I have my camera charger on my list, but if not I'll add it.I like my Jam and have had lots of use with it. However, I bought a ULA CDT with some Amazon credit I had for selling old textbooks (mainly so I could then sell it here and turn that credit into cash I could use) and was wondering if you guys have had experience with one. I may end up seeing which I like better and selling the other to my brother at a good discount as they're both supposed to be pretty good packs.
George,Lots of people have done thru-hikes with both packs. I prefer internal frames for long trips.Here is my take on the CDT, I think it is the old Conduit model (or close to it). I had one and didn't care for it, because it wasn't convenient to "live out of it." Now this is just a personal preference. I didn't like the water pockets because Platys would fall out of them. I don't care for mesh pockets because they stretch and rip. It had no other external pockets. It just didn't allow me to be as efficient daily as some other packs. If the Jam works for you and is the right size for all your gear, you may want to use that. I would do some hikes with the CDT ahead of time and keep an eye on how the pack works from an efficiency view point. I know lots of people do the PCT with the CDT, so there are many fans out there.
Just a slight correction, alcohol stoves (and other non-controlled flamed stoves such as wood burning stoves) were banned in many parts of Colorado for a good chunk of last summer.Does not necessarily mean they will be banned this coming year.All depends on how dry this winter is and if we have a wildfire season like last year (I hope not!!!!!)
"Does not necessarily mean they will be banned this coming year."Have you heard of global warming? : )It will probably be drier most summers in the futureBut, after all the forests are burned down it won't matter, so they can go back to allowing alcohol stoves
I finally had a chance to weight everything of mine on a scale and was very surprised -- some things were much heavier than advertised (my bag is 25oz as compared to 19oz) or lighter than advertised (not as many items in this category). This ended up bringing my pack weight over 13lbs.However, if I end up liking the CDT in the next few hikes and decide to use it, I'll ditch the REI inflatable pad and use my folded thermarest ccf pad as the support in the pack. It's always uncomfortable the first few nights but is fine after that. In total, those two switches would drop my base weight to around 11.3 lbs.
Edited by nsiderbam on 01/09/2013 06:21:28 MST.
Yes, I've heard about global warming..But I've also read it is called climate change and has unpredictable weather patterns.If we get a walloping in Colorado with snow in May (as in 2011. I was skiing in June that year), it also means alcohol stoves won't necessarily be banned as it was last year.Even if the weather IS hotter overall, the weather patterns are all messed up. The Colorado Trail could very well be snowed over again well into July as in 2011.So, I stand by my original assertion: An alcohol stove ban last year does not mean stoves will be banned this summer.I guess my question to you is "Do you have any historic memory beyond a snarky line in a post?" :)mid-late July 2011:http://www.pmags.com/devils-thumb-loop-indian-peaks-wildernesSame loop in early August 2012:http://www.pmags.com/high-and-lonesome-reduxI'm not as smart as others and can't predict what the weather will be like in 5 mos... ;)
Edited by PaulMags on 01/09/2013 07:42:44 MST.
"Do you have any historic memory beyond a snarky line in a post?" No, sorry, just trying to be humorous, didn't mean to be dis-respectful or anything : )However, it does seem like weather patterns are changing so alcohol stoves won't be allowed more often - maybe that's a better way to say what I meantAnd I don't like to concede the term "global warming" to the deniers. The globe is warming. Maybe that causes some specific locations to change but not necesarily warm.
George I noticed you plan on doing the CT in 22 days and then going straight back to Annapolis. After I did 23 days on the CT I was wiped out for about a week when I got home. I'd consider how tired out you want to be before jumping back into a military academy. I am NOT saying don't go. I'm just saying make sure you are ready. My main problem was my limited training before the trip. I could do 20+ mile days but I was sore the next day. I hiked through the soreness but remember I was very beat up when I got home. If you can hike 20 miles or a bit more comfortably then you should be fine. If 20 miles a day is a big stretch then you'll struggle.
"George I noticed you plan on doing the CT in 22 days and then going straight back to Annapolis. After I did 23 days on the CT I was wiped out for about a week when I got home. I'd consider how tired out you want to be before jumping back into a military academy.":)umm... it's a military academy. Most those dudes are in pretty good shape.
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Attempted murder charge for man accused of shooting his uncle
YAKIMA, Wash. -- The Harrah man accused of shooting his uncle is now charged with attempted murder.
David Fernandez's first appeared in court Monday. He was originally booked for first degree assault.
Prosecutors charged him Wednesday with first degree attempted murder and assault.
Deputies said Fernandez shot his uncle six times in the back and once in the head.
Roberto Ocampo-Ursino remains in a Yakima hospital.
Deputies said Fernandez got angry when his uncle wanted to end their sexual relationship.


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Testing Objective Methods for Template Matching Ventricular Tachycardia and Pacemapping
Recruitment status was Recruiting
- Full Text View
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- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Patients sometimes suffer from life-threatening abnormal heart racing that originates from the lower chamber of the heart. These patients will often need an implantable defibrillator which has the ability to shock the heart back to a normal heart rhythm, but this does not prevent them from getting frequent recurrences of the bad heart rhythm needing shocks from the device. This can be painful and potentially harmful. Medicines to prevent recurrences of shocks are not very effective and have many side effects. An alternative to medicines for this is a procedure called a catheter ablation in which a wire is passed up through the blood vessels of the leg into the heart and used to find the short circuits which cause the dangerous heart rhythm. When the spot causing the trouble is found, the investigators can burn it ("ablate" it). This procedure is challenging and methods are needed to make it more effective and easier to do. One of the main ways for finding the short circuits involves using the electrocardiogram (the "ECG"). The regular ECG is simplistic and only makes use of recordings from 10 sites (6 precordial sites and 4 sites on both upper and lower limbs) on the body surface. The investigators are testing whether making recordings from 120 sites on the chest and back and using special computerized analysis of the recordings can help make catheter ablation for dangerous heart rhythms more effective.
Ventricular Tachycardia
|Study Type:
|Study Design:
|Observational Model: Cohort
Time Perspective: Prospective
|Official Title:
|Quantitative Measurements Comparing Body Surface Potentials During Pacemapping and Spontaneous Ventricular Tachycardia
- Correlating the arithmetic markers (CORR and MAD) to the distance between the pacing site and origin of the ventricular tachycardia or the index pacing site. [ Time Frame: One year ] [ Designated as safety issue: No ]
|Estimated Enrollment:
|Study Start Date:
|July 2010
|Estimated Study Completion Date:
|July 2011
|Estimated Primary Completion Date:
|July 2011 (Final data collection date for primary outcome measure)
|focal VT .
|Scar related VT, exit not identified
|Scar related VT exit identified
|Supreventricular tachycardia
Show Detailed Description
|Ages Eligible for Study:
|18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
|Sampling Method:
|Non-Probability Sample
Patients will be recruited from consecutive patients referred for ablation of sustained ventricular tachycardia with or without structural heart disease or Patients referred for ablation of supraventricular tachycardia to the QEII Health Sciences Centre, in Halifax, NS.
Inclusion Criteria:
- All patients presenting with sustained monomorphic VT who are amenable to VT ablation.
- Patients referred for ablation of supraventricular tachycardia.
Exclusion Criteria:
- Patients presenting with ventricular tachycardia if no sustained tachycardia can be induced, or if in that particular patient pace-mapping is known to be an inaccurate method of mapping (e.g. in bundle branch reentry VT or fascicular VT).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170416
|Canada, Nova Scotia
|Capital District Health Authority
|Halifax, Nova Scotia, Canada, B3H 3A7
|Contact: John Sapp, MD FRCPC 473 4272 email@example.com
|Principal Investigator: John A Sapp, MD, FRCPC
|Sub-Investigator: Ahmed El-Damaty, MD MSc
|Principal Investigator:
|John A Sapp, MD, FRCPC
|Nova Scotia Health Authority
|Responsible Party:
|Dr John Sapp, Capital District Health Authority
|ClinicalTrials.gov Identifier:
|NCT01170416 History of Changes
|Other Study ID Numbers:
|Study First Received:
|July 25, 2010
|Last Updated:
|June 21, 2011
|Health Authority:
|Canada: Ethics Review Committee
Keywords provided by Nova Scotia Health Authority:
Ventricular Tachycardia
Body Surface Mapping
Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
ClinicalTrials.gov processed this record on October 13, 2015


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Multicenter Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy (MLD) (IDEAMLD)
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- How to Read a Study Record
The purpose of this study is to determine the safety of ascending doses of HGT-1110 administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with metachromatic leukodystrophy (MLD).
Metachromatic Leukodystrophy
Biological: Recombinant human arylsulfatase A
Phase 1
Phase 2
|Study Type:
|Study Design:
|Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:
|A Phase I/II Multicenter Open-label Dose Escalation Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy
- Cohorts 1-3: Safety of IT HGT-1110 administration [ Time Frame: 42 weeks ] [ Designated as safety issue: Yes ]Safety will be assessed by AEs (by type and severity), changes in clinical laboratory testing, electrocardiogram (ECG), vital signs, CSF chemistries and antibodies.
- Cohort 4:Safety of the administration of IT HGT-1110 produced with a revised drug substance manufacturing pro [ Time Frame: 42 Weeks ] [ Designated as safety issue: Yes ]Safety will be assessed by AEs (by type and severity), changes in clinical laboratory testing, electrocardiogram (ECG), vital signs, CSF chemistries and antibodies.
- Clinical activity of IT administration of HGT-1110 on gross motor function [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]Change from baseline in gross motor function
- Serum Pharmacokinetic profile of HGT-1110 after single and repeated dose administration (weeks 0 and 38) [ Time Frame: 12 time points over 48 hours post-dose ] [ Designated as safety issue: No ]
- Cmax: maximal serum concentration
- Tmax: time to reach Cmax in plasma
- AUC: area under the curve
- Concentrations of HGT-1110 in CSF [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]Concentrations of HGT-1110 in CSF prior to each IT administration
|Estimated Enrollment:
|Study Start Date:
|August 2012
|Estimated Study Completion Date:
|April 2018
|Estimated Primary Completion Date:
|April 2018 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: Cohort 1 (10 mg)
6 patients treated with HGT-1110 10 mg EOW by IT injection
Biological: Recombinant human arylsulfatase A
Other Name: HGT-1110, rhASA
Experimental: Cohort 2 (30 mg)
6 patients treated with HGT-1110 30 mg EOW by IT injection
Biological: Recombinant human arylsulfatase A
Other Name: HGT-1110, rhASA
Experimental: Cohort 3 (100 mg)
6 patients treated with HGT-1110 100 mg EOW by IT injection
Biological: Recombinant human arylsulfatase A
Other Name: HGT-1110, rhASA
Experimental: Cohort 4 (100 mg)
6 patients treated with HGT-1110 100 mg EOW by IT injection
Biological: Recombinant human arylsulfatase A
Other Name: HGT-1110, rhASA
Detailed Description:
Metachromatic leukodystrophy (MLD) is an inherited, autosomal recessive disorder of lipid metabolism characterized by deficient activity of the lysosomal enzyme, arylsulfatase A (ASA). MLD is a rare disease that occurs in most parts of the world. The estimated overall incidence of the disease in the western world is approximately 1 in 100,000 live births that varies by geographic location. There are no approved therapies for MLD.
This is a multicenter, open-label, dose-escalation study designed to evaluate the safety of up to 3 dose levels (10, 30, or 100 mg) of HGT-1110 administered via an intrathecal drug delivery device (IDDD) every other week (EOW) for a total of 38 weeks (20 injections, Weeks 0 to 38) to children with MLD. The study also includes the assessment of HGT-1110 drug product produced with a revised drug substance manufacturing process (referred to as Process B) in a fourth cohort (Cohort 4). Up to 24 patients will be enrolled and will receive treatment of HGT-1110. Patients will be sequentially enrolled into 4 dose cohorts, 6 patients each. Patient enrollment will be staggered in this study to facilitate adequate safety monitoring per dose cohort.
|Ages Eligible for Study:
|up to 12 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
Confirmed diagnosis of metachromatic leukodystrophy by both:
- Arylsulfatase A (ASA) deficiency by assay in leukocytes AND
- Elevated sulfatide in urine
- Appearance of the first symptoms of disease at or before 30 months of age.
- Ambulatory at the time of screening. The minimum level of function required to meet this criterion is defined as the ability to walk forward 10 steps with one hand held.
- The patient is less than 12 years of age at the time of screening.
- Neurological signs of MLD must be present at the screening examination.
- The patient and his/her parent/representative(s) must have the ability to comply with the clinical protocol.
- Patient's parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. Study-related activities are any procedures that would not have been performed during normal management of the patient.
Exclusion Criteria:
- History of hematopoietic stem cell transplantation (HSCT).
- The patient has any known or suspected hypersensitivity to anesthesia or is thought to be at an unacceptably high risk for anesthesia due to airway compromise or other conditions.
- Any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial.
- The patient is enrolled in another clinical study that involves the use of any investigational product (drug or device) other than HGT-1110 or the IDDD used in this study within 30 days prior to study enrollment or at any time during the study.
- The patient is pregnant or breastfeeding.
The patient has a condition that is contraindicated as described in the SOPH-A-PORT Mini S IDDD Instructions for Use (IFU), including:
- The patient has had, or may have, an allergic reaction to the materials of construction of the SOPH-A-PORT Mini S device.
- The patient's body size is too small to support the size of the SOPH-A-PORT Mini S Access Port, as judged by the Investigator.
- The patient has a known or suspected local or general infection.
- The patient is at risk of abnormal bleeding due to a medical condition or therapy.
- The patient has one or more spinal abnormalities that could complicate safe implantation or fixation.
- The patient has a functioning CSF shunt device.
- The patient has shown an intolerance to an implanted device
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510028
|Hospital Universitário Austral
|Buenos Aires, Pilar, Argentina, B1629AHJ
|The Children's Hospital at Westmead
|Active, not recruiting
|Westmead, Australia, 2145
|Hospital de Clinicas de Porto Alegre
|Active, not recruiting
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
|København, Denmark, 2100
|Contact: Pernille Stroem firstname.lastname@example.com
|Principal Investigator: Christine Dali, MD
|Hopital de Bicetre
|Le Kremlin Bicetre, Ile-de-France, France, 94275
|Contact: Marine Chavaudret firstname.lastname@example.com
|Principal Investigator: Caroline Sevin, MD
|Center for Pediatric Clinical Studies
|Tubingen, Baden-Wuerttemberg, Germany, 72076
|Contact: Annette Hark email@example.com
|Principal Investigator: Joachim Riethmuller, MD
|Osaka University Hospital
|Not yet recruiting
|Suita, Japan, 565-0871
|Principal Investigator: Norio Sakai, MD
|Study Director:
|Margaret Wasilewski, M.D.
No publications provided
|Responsible Party:
|ClinicalTrials.gov Identifier:
|NCT01510028 History of Changes
|Other Study ID Numbers:
|Study First Received:
|December 14, 2011
|Last Updated:
|October 8, 2015
|Health Authority:
|Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Shire:
Metachromatic Leukodystrophy (MLD)
Recombinant human arylsulfatase A (rhASA)
Intrathecal Drug Delivery Device (IDDD)
Additional relevant MeSH terms:
Leukodystrophy, Metachromatic
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Central Nervous System Diseases
Demyelinating Diseases
Genetic Diseases, Inborn
Hereditary Central Nervous System Demyelinating Diseases
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Lysosomal Storage Diseases, Nervous System
Metabolic Diseases
Metabolism, Inborn Errors
Nervous System Diseases
ClinicalTrials.gov processed this record on October 13, 2015


text: This is a sword from The Legend Of Zelda, the game was created by the Nintendo company, and they made a lot of cool games. The sword had power to diffete Ganon. The master sword was found in the Temple Of Time in The Legend Of Zelda Ocerina Of Time on the stone after opening the door.


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Salted Caramel Apple Pue Bars - you won't be able to get enough of these delicious bars.#63713
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This Balsamic Cherry Sauce is easy to make and has a taste reminiscent of caramel sauce.#63670
Combining some of the freshest summer flavours, these cucumber lime mint popsicles are a light, refreshing treat.#63668


text:
My name is Debbie Ott and I've actually been sewing for over 30 years, but this is the first time I have sewn as a full time business.
I started Debbie's Custom Sewing and Alterations five years ago after moving to Price from Salt Lake. In Salt Lake, I worked for an insurance company for 15 years and have my agent's license, but I'm having more fun sewing.
I love it here in Price, and with my sewing business, I have met the nicest people. I pick up and deliver the sewing for those that can't get out, and usually end up visiting with them for quite awhile. Price, Helper and Wellington communities are keeping me very busy.
My number is 613-9790 for all your sewing needs.


text:
Visit www.CherokeeBillie.com - Call 866.563.3997
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Tips and stories on homemaking, homemade dishes, homecooked food, home remedies for health
A Self-Development Blogging Community of Higher Awareness
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Inspiration received and put forth for the good of the people
Wellcome to my blog my name is Beth i live in Wales in the UK its full of green grass and lots of hill oh and sheep haha.i wanted to start a blog so i could write about my life , my journey on finding my self , my kids and anything that is on my mind which could be anything from make up , men , chocolate ANYTHING. I suppose its sort of like a dairy.i dont get to spent as much time as i would like on here but starting from today i am going to make the time even if its for just 10 small moments
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Discovering the Gift


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Some stereotypes are grossly unfair and not very flattering. That said, when the shoe fits, wear it, and as an Italian American, I fit the stereotype of being emotional (I know) and passionate (I think). Cest la vie.
But I realized today that in that gamut of emotions there is one I regret.
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reverse seam shirt
by STEVEN ALAN
Women's Size Chart
Product Details
Our seasonless, signature style. The twisted placket, tailored, slim fit, French seams and shirttail hem set it apart from the average button down.
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• 100% cotton
• machine wash cold
• made in the USA


text: On the corner of Presidio Place and Quantico, near Youngs Road in Amherst, you will find an amazing Halloween house. It helps that the man of the house is an electrician! It's best to see it in person, but if you can't make it, click on the video link to see Kevin O'Neill's live visit!


text:
APN: 2a-125-0000 Trust No. 1274877-07 Ref: Sam Farlaino TRA: Loan No.
xxxx5561. IMPORTANT NOTICE TO PROPERTY OWNER: YOU ARE IN DEFAULT UNDER
A DEED OF TRUST, DATED May 25, 2007. UNLESS YOU TAKE ACTION TO PROTECT
EXPLANATION OF THIS PROCEEDING, YOU SHOULD CONTACT A LAWYER. On
February 07, 2011, at 11:00am, James H. Woodall, as duly appointed
Trustee under a Deed of Trust recorded May 31, 2007, as Instrument No.
123675, in Book 646, Page 780, of the Official Records in the office
at the County Recorder of Carbon County, State of Utah, executed by
Sam A. Farlaino An Unmarried Man, will sell at public auction to
highest bidder, payable in lawful money of the United States at the
time of sale. Successful bidders must tender a deposit of $5,000 in
certified funds to the trustee at the time of sale, with the balance
due by noon the following business day, at the office of the Trustee.
At the main entrance of the carbon county district court 119 E. 100 S.
Price Utah all right, title and interest conveyed to and now held by
it under said Deed of Trust in the property situated in said County
and State described as: All of lot 1, block 4, scofield campsite
subdivision, according to the official plat thereof, recorded in book
3 of plats, at page 111, reords of the Carbon county recorder.
excepting therefrom all oil, gas and other minerals and mineral rights
in and to said lands. The street address and other common designation
of the real property described above is purported to be: Lot 1 Block 4
Scofield Ut 84526. Estimated Total Debt as of February 07, 2011 is
$270,085.62. The undersigned Trustee disclaims any liability for any
incorrectness of the street address and other common designation, if
any, shown herein. Said sale will be made without covenant or
warranty, express or implied, regarding title, possession, condition
or encumbrances, including fees, charges and expenses of the Trustee
and of the trusts created by said Deed of Trust, to pay the remaining
principal sums of the note(s) secured by said Deed of Trust. The
current beneficiary of the Trust Deed as of the date of this notice
is: Ocwen Loan Servicing, Llc. The record owner of the property as of
the recording of the Notice of Default is/are: Sam A Farlaino. Dated:
January 06, 2011. James H. Woodall 10653 River Front Parkway, Suite
290 South Jordan Ut 84095 (801)254-9450 (800)245-1886 (Hotline)
Hours: 9:00 A.M. - 5:00 P.M. Signature/by: James H. Woodall R-361925
01/06/11, 01/13/11, 01/20/10
Published in the Sun Advocate January 6, 13 and 20, 2011.


text:
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text:
Exelon is committed to strengthening and enriching the communities where we operate. We foster a culture focused on integrity, diversity, safety and volunteerism.
Exelon has a strong tradition of community involvement – of committing our energy for the community. Volunteerism allows us to put a personal face on our corporate citizenship initiatives. We work to strengthen and enrich our communities not only with contributions of time and money, but also by increasing opportunities for youth through education and science. To ensure the security of our customers and our communities, we maintain both vigilance in emergency response preparation and public safety outreach.
Exelon's Corporate Citizenship program strives to improve the quality of life for the people who live and work in our service territory and around our power plants. We seek to accomplish these goals through employee volunteer activities and executive involvement on non-profit boards.
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Exelon believes that a broad approach is required to better enrich the communities we serve. Every company has a vision of tomorrow. Ours is pragmatic, focused on the people and programs we know will help us get there.
In 2013, Exelon provided over $32 million in grants to non-profit organizations. Our employees pledged over $5.9 million for the annual Exelon-United Way campaign. We focus our corporate giving in four areas and give to the communities in which we live and serve and encourage our employees to support the organizations that they value.
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text:
Earlier today T-Mobile announced that the HTC Unlocked ( myTouch 3G Slide ) will become available to shoppers on June 2nd. While the myTouch 3G Slide is nowhere near the most advanced Android smartphone on the market many people are very excited about its pending release. This particular handset will come with the Android OS which is quickly becoming the most popular operating system for cellular devices. In addition to that there will be many top notch features included with the myTouch 3G Slide that is easily going to this a great smartphone.
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Dry Suits
Ocean Rodeo Ignite DrysuitLoaded with expedition style features, the Ignite is designed to be worn for extended periods of time above and beyond a quick after work session. Whether you are kiting through winter, expedition SUP'ing, or testing your limits sailing across the Atlantic, the Ignite delivers the highest levels of comfort, durability and all weather marine protection, blurring the line between dry-suits and foul weather gear. Learn More$1,049.00