Milan

9 Truths About Letting Go of Opinions that Taint Us.

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I have learned silence from the talkative, toleration from the intolerant, and kindness from the unkind; yet, strange, I am ungrateful to those teachers. ~Khalil Gibran

1. Smoke and Mirrors

The fear of imperfection and/or of not being accepted is, of course, an illusion. Who gets to be the judge and jury on what is deemed beautiful or hideous — successful or stupid? Let me guess:  The tabloids or magazines, possibly Hollywood or the catwalks of Milan? How about TV/movies and the media? Spare a thought about who you give your power over to.  The various outlets that dictate what beauty and normal are seem to be pushing fake, in my opinion.  There are moments where true beauty can shine through these channels, but those flashes are few and far between.  True beauty and acceptance is in the eye of the beholder.  So anyone claiming to know what beauty or normal definitely is needs very close examining if they are not including every member of the human race in their rundown.

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2. Self-Realization and Repair Kits

When you can out these undesirable contracts you can begin to repair them.  We have to discover why we felt the lack and how we are feeling now about the same issue. Then we must align it to our higher self by breaking down the agreement piece by piece and offer it up to the light to be cleansed.

3. Inherent Beauty and Perfection

We need to look at ourselves and find the beauty inherent in us, not always trying to fish out our perceived faults. When you treat yourself with loving kindness and nurture your self-esteem with positive thoughts, you will begin to shift into alignment with your higher self.

4. Dissecting Agreements

When we were young we had no inhibitions and sang at the top of our voices, danced our hearts out (whether someone was looking or not) and thought we were princesses and superheroes. Then one day someone came along and made you feel less than what you felt about yourself. You may have paused to take it in – then you made a crucial decision. Either you agreed with what they said or you didn’t. That is why some of us can still dance freely and not be bothered whilst others cringe at the thought of dancing in public – this could be due to an earlier experience of being made to feel like you were ‘no good’ by someone who was only giving you one piece of the puzzle.

Care about people’s approval and you will be their prisoner. ~Lao Tzu

5. Piecing Together Your Puzzle 

When I said that the person was only giving one piece of the puzzle I mean that they have a preference based on their version of reality. That is one person’s perspective in a sea of other possible candidates – ones who may have loved your form of expression.  This person could have also been a child, an acquaintance, a stranger or it could have been someone you trusted and loved deeply. The latter is often the case and can make the hurt twice as potent.  However, we must consider that some things are said in the heat of the moment and not really meant by the offender, so we really need to see why we made the agreement.

6. That Tricky Enigma Called Universal Appeal

You need to know that you can never have universal appeal.  You or your talents may not be one person’s cup of tea but what about all the other people in the world who will resonate with your particular brand of uniqueness?  However, ultimately you need to please only you. When you do this then you are immediately accepted and no outside influence can make you feel anything other than what you know yourself to be.

7. Acknowledge the Good

We sometimes tend to disregard the ones who encourage us, leaving only space in our thoughts for the ones who hurt us. Why is this, I wonder?  Everyone has the urge to be liked and accepted for who they are. This is normal. But what we need to redefine is whatis normal? Every soul is special and has equally unique attributes, abilities and ways of expressing themselves creatively. There should be no judgment.

8. Identify the Judge 

When judgment rears its head, we must question the one doing the judging.   Tell that judge that you are in love with your differences.  Viva la difference!  Without freedom of expression this world would be a very dull place.  Without diversity in hair colour, body shapes, talents, voices, tastes, etcetera we would be tantamount to sheep running around in a field day in and day out – baa-baa-boring!

9. Know Thyself! 

Only then will you begin to discover, on the deepest level, that which you truly are and what you have accomplished – not only in this lifetime but in the countless life experiences you have had.  Draw on that wealth of talents you have stored, that which you haven’t even begun to extract from your being.  When you do, there is nothing anyone can say or do to you that would ever hurt you.  You will be resolute as to who you are and nobody can take that away from you — unless you allow them to.

When you are living with the statement ‘be the best you can be’ and you are doing this with all your integrity and might — you have nothing to fear.

Empowerment comes from fearing no-thing and facing every day with courage and love in your heart. Strive to be and do the best you can in every situation, then you will be living in your integrity.  Words or energy that does not fit with your frequency or vibration will not be allowed to penetrate your field of self.  You will have become the master of your life and your reality.

Source: purposefairy.com

In Berlin, crisis breeds creative business.

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On a typical autumn evening at a low-lit, retrofitted bar in Berlin’s Prenzlauer Berg district, the cozy murmur of conversation and music seems to foreshadow the approaching cold months. But tonight, a mysterious group in black clothing pours through the front door, and one of them begins presenting patrons with small, white menus.

“Hi, my name is Serena,” the tall, dark-haired woman says with a smile. “I’m from Theater am Tisch (Theater at the Table), and this is the evening’s selection of dramatic pieces.”

The menu contains a list of scenes from cinema and stage, including one from the movie American Beauty, with monologues priced at 1.50 Euros and duets at 2 Euros per audience member. Serena nods in acknowledgement of some orders, situates empty chairs alongside the table, and whisks away to her colleagues at the other end of the bar.

Soon a man and woman take their seats at the table, placing a candle at its center. “The flame indicates the start of the scene,” they explain, lighting the candle.

The scene plays out believably: raised voices cause heads to turn, but only momentarily. The space of the tiny table seems to contain the captivating drama. Afterwards, thin but enthusiastic applause at the table is followed by handshakes and exchanges between the actors and their patrons.

It isn’t long before surrounding tables sneak a secondary peak at their menus and motion Serena over to place their orders.

Italian-born Serena Schimd launched Theater am Tisch in Berlin after moving to the city from Milan, where economic hard times put her previous employer out of business and made work generally difficult to find.

“We needed new opportunities,” Schimd says of herself and boyfriend Emiliano Saurin, a mobile web developer and entrepreneur.

“You can’t do the things you can do in Berlin in Milan; it’s too expensive. Here we can try things and see how they work without worrying about how to survive at the same time.”

Schimd and Saurin aren’t alone: Germany saw a drastic influx of immigrants from European Union countries in 2011, according to a report by the German Ministry of Migrants and Refugees. Immigration from places such as Greece increased as much as 90 percent from 2010.

Italian immigrants to Germany in 2011 ranked fifth in number among E.U. nations after those from Poland, Romania, Bulgaria and Hungary.

An interior designer by trade, Schimd says Theater Am Tisch started when she and some friends developed the business as part of a cultural association near Milan. With the project enjoying modest success in Milan after only a year, she immediately recognized a potential market in Berlin.

“There’s a lot of culture here,” she says. “You don’t have to ‘rent’ a bar to offer something like this; locale owners are happy to have you come in and try something new. Milan, on the other hand, is kind of a closed city. It’s a fashion hub, so there’s a lot of money there, and you have to pay to visit places, and you never know how much you’re going to earn.”

Schimd says Theater am Tisch – whose Berlin rendition includes nine actors from three countries — has been booked to perform at an upcoming awards show in Berlin, and that she is working to warm restaurants up to the concept.

“In Berlin, we’ve actually found it hard to get people to reserve performances because there’s often too many things to do in the city. That actually worked better in Milan, where this was more about food: people enjoyed the idea of sitting down to a dinner and ordering performances between courses.”

But Schimd says the project’s spontaneity has been surprisingly welcome in Berlin. She has even been able to raise prices in hip, upscale neighborhoods such as Prenzlauer Berg.

“We’re looking forward to the winter, when everyone is together inside bars and cafes in the evening and pleased to come across something new.”

Source: Smart Planet.

 

Many Women whose Tumors Disappear after Chemotherapy Have Mastectomies.

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Many women with breast cancer whose tumors disappear after presurgical chemotherapy have a mastectomy instead of breast-conserving surgery, according to a re-analysis of data from the NeoALTTO trial. The results were presented September 30 at the 2012 European Society for Medical Oncology Congress(ESMO).

In the phase III trial, investigators randomly assigned women with HER2-positive breast cancer to receive trastuzumab, lapatinib, or both drugs for a total of 18 weeks prior to surgery. (Both drugs target the HER2 receptor.) After the first 6 weeks, paclitaxel chemotherapy was added to the anti-HER2 treatments.

In 160 of 429 women, the tumors disappeared (a pathologic complete response). But whether a woman had a pathologic complete response did not influence the type of surgery she had later. Although women receiving all three drugs were up to twice as likely to have their tumors disappear as women who received only a single anti-HER2 drug plus paclitaxel, they were no more likely to have breast-conserving surgery than a mastectomy.

Instead, the ultimate choice of surgery type was more strongly influenced by the characteristics of the tumor before chemotherapy, including the initial tumor size and whether the tumor expressed the estrogen receptor, as well as the type of surgery originally planned and whether the cancer was multifocal or multicentric.

One of the main goals of presurgical (neoadjuvant) chemotherapy is to “downstage” larger tumors to allow less-aggressive surgery. Therefore, “there is a need for a clear consensus on the role of breast-conserving surgery, especially in patients who respond to neoadjuvant therapy,” said lead investigator Dr. Carmen Criscitiello, of the European Institute of Oncology in Milan, Italy, at an ESMO press conference.

“This will ultimately translate…into improved breast-conservation rates, [and] could spare more women from receiving radical treatment like mastectomy,” she concluded.

Source: NCI.

 

 

 

New data for Novartis drug Lucentis® confirms long-term efficacy and safety profile and benefits of individualized treatment .

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  • REPAIR study shows an average of three Lucentis® injections improve visual acuity in patients with myopic choroidal neovascularization
  • RESTORE extension study demonstrates DME patients fully maintained initial vision gains with an average of 13.9 Lucentis injections over three years
  • Retrospective analysis reinforces Lucentis well-characterized safety profile in wet AMD; ongoing LUMINOUSTM program now involves over 10,000 patients

 

New data for Lucentis® (ranibizumab), the only anti-VEGF therapy licensed across three ocular indications, show that individualized treatment with Lucentis provides sustained improvement in vision with a low number of injections. It is estimated that over 80% of visual impairment is preventable when due to conditions such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and visual impairment due to macular edema secondary to retinal vein occlusion (RVO)[1]. These conditions can eventually lead to blindness if left untreated.

 

“Lucentis has become the standard of care in wet AMD and has helped to significantly improve vision in a majority of patients with this disease.” said Tim Wright, Global Head of Development, Novartis Pharma. “These new data confirm that an individualized treatment approach can lead to optimal improvements in vision with a low average number of treatments, thus ensuring that patients with retinal diseases are not over- or under-treated. In addition, these data add to the well-characterized safety profile of Lucentis”.

 

Lucentis also demonstrated benefits in visual acuity outcomes in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathological myopia (PM). Lucentis is currently not approved to treat this condition. Novartis will submit for regulatory approval in this indication in the European Union in the third quarter of this year and in Japan by the end of 2012.

 

Novartis is dedicated to the research, development and manufacturing of ophthalmic pharmaceuticals. The mission of Novartis in the field of ophthalmology is to discover, develop and manufacture innovative products to improve eye health and enhance people’s lives.

 

Lucentis study highlights at the 12th European Society of Retina Specialists (EURETINA) Congress in Milan, Italy include[2]-[4]:

 

REPAIR

This one year study performed in twelve centers in the United Kingdom explored the efficacy and safety profile of 0.5 mg Lucentis administered on an individualized basis in 65 patients with myopic CNV. After six months of treatment, mean visual acuity improved by twelve letters. Patients received an average of three Lucentis injections with 29 % requiring no further treatment beyond the first injection. This analysis shows that Lucentis therapy leads to improvement in visual acuity in patients with this condition. The six month interim results and the full one year data will be presented at Euretina. Currently, photodynamic therapy with Visudyne® (verteporfin) is the only approved medical treatment for this condition.

 

RESTORE

In the RESTORE extension study, 240 patients with DME received individualized treatment with Lucentis according to a regimen consistent with the European Union label. Results showed that patients who were originally treated with Lucentis received an average of 13.9 injections over three years. 19-25% of patients across all study arms did not require any Lucentis injections during years two and three. An average of 3.7 injections in the second year and 2.7 in the third year were sufficient to fully maintain the mean of seven letters of visual acuity gained in the RESTORE core study. The safety profile was consistent with previous studies conducted in other indications. There were no cases of endophthalmitis reported within the RESTORE core and extension studies.

 

“The results of this study show that individualized treatment with Lucentis can lead to a significant improvement in vision and that these improvements are sustained in the long term” said Professor Francesco Bandello, Department of Ophthalmology, Hospital San Raffaele, University Vita Salute San Raffaele, Milan, Italy and president elect of EURETINA. “It is important that we explore how these insights apply to real-world clinical practice to ensure that we are providing the best possible care for our patients”.

 

LUMINOUS

The Luminous program is one of the largest observational studies in ophthalmology and consists of two parts launched in 2011. The retrospective part comprises pooled data from four European registries of nearly 4,500 patients with wet AMD treated with Lucentis. These data showed no new safety signals for Lucentis and reinforces its well-characterized safety profile. The registries revealed low incidences of key adverse events at 12-months. Additionally, a low number of Lucentis injections were observed during the first year. The mean number of Lucentis injections over twelve months ranged from 4.3 to 5.0 (based on all patients) and 4.7 to 5.5 (based on patients completing one year).

 

The prospective part of Luminous is expected to provide important long-term evidence on the real-world effectiveness and safety profile of Lucentis in its licensed indications. This 5-year study is ongoing and currently has more than 5,500 patients enrolled. It is expected to recruit more than 30,000 patients from clinics across Asia, Australia, Europe, North and South America.

 

About Lucentis® (ranibizumab)

Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in wet AMD and other ocular diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO). Lucentis has been designed, developed and formulated specifically for use in ocular disease with the aim of stabilizing and improving visual acuity in these patients, while minimizing the risk of systemic side effects.

 

Lucentis is licensed for the treatment of wet AMD in more than 100 countries, in more than 80 countries for the treatment of visual impairment due to DME and in 80 countries for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. In many countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.

 

Novartis and Alcon sponsor the eXcellence in Ophthalmology Vision Award (XOVA). XOVA is an annual award launched in 2010 that provides funding to non-profit initiatives and projects that will have a positive impact on improving the quality of eye care and make a significant impact in addressing unmet needs in the fields of ophthalmology and optometry.

 

Lucentis has a well-characterized safety profile and Novartis systematically monitors the safety and tolerability of Lucentis for licensed indications on an ongoing basis. Its safety profile has been well established in a clinical development program that enrolled more than 10,000 patients across indications. Since its launch in the United States in 2006, there are more than one million patient-treatment years of exposure for Lucentis.

 

Serious adverse events related to the injection procedure include endophthalmitis, retinal detachment, retinal tear and traumatic cataract. Other serious ocular events observed among Lucentis-treated patients included intraocular inflammation and increased intraocular pressure. Non-eye related serious side effects, although not common, include heart attacks, strokes and death.

 

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.

 

References

[1] Pascolini D and Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol 2012;96:614-618.

[2] Tufail A on behalf of the REPAIR study group. The REPAIR study: 12 Month, prospective, multi-center trial of ranibizumab in choroidal neovascularization (CNV) due to pathological myopia (PM). EURETINA 2012.

[3] Lanzetta P on behalf of the RESTORE study group. Long-term safety and efficacy outcome of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema: the RESTORE extension study. EURETINA 2012.

[4] Bandello F on behalf of the LUMINOUS group. Outcomes of the retrospective pooled safety analysis of ranibizumab therapy for neovascular age-related macular degeneration from four european registries and update on the ongoing prospective analysis for the LUMINOUS study. EURETINA 2012.

 

 

Source: Novartis newsletter