Life Sciences Translation

Showing 10 of 105 excerpts · In an opened excerpt, underlined terms show what they mean in clinical use

1. 1Title (Type 2 Diabetes)DiabetesRandomisedDouble-blindPlacebo-controlledActive comparator

   A Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus with Optional 26-Week Active Comparator-Controlled Extension Periods [Rivoglitazone and pioglitazone are the "study drugs" for this extension study. Rivoglitazone is an investigational drug. An investigational drug is a drug that is still being studied and has not been approved by the United States Food and Drug Administration (FDA) and the Drug Controller General of India [DCG(I)] or by other regulatory agencies around the world. The use of rivoglitazone is permitted for research purposes only. Pioglitazone is approved by the US FDA and other regulatory agencies for the treatment of type 2 diabetes under the commercial name "[withheld]". It is used in this extension study for comparison purposes.]

2. 2[withheld]-HIV QuestionnaireHIVconsists of 70 questions which assess 11 dimensions of health-related quality of life including general health perception, social relationships, emotional distress, energy/fatigue, sleep, cognitive functioning, physical activities, coping, future, impact of symptoms and side effects, and treatment. In addition, one item assesses resources (financial difficulties), one item assesses satisfaction with care and one item the level of worry caused by the difficulties of having a child.

   consists of 70 questions which assess 11 dimensions of health-related quality of life including general health perception, social relationships, emotional distress, energy/fatigue, sleep, cognitive functioning, physical activities, coping, future, impact of symptoms and side effects, and treatment. In addition, one item assesses resources (financial difficulties), one item assesses satisfaction with care and one item the level of worry caused by the difficulties of having a child.

3. 3Quality of Life HIV QuestionnaireHIVthese questionnaires ask about how HIV and its treatment have affected a patient's health and life over a certain period.

   these questionnaires ask about how HIV and its treatment have affected a patient's health and life over a certain period.

4. 4Title (Pulmonary Arterial Hypertension)Pulmonary hypertensionPhase IIIRandomisedDouble-blindPlacebo-controlled

   A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group, Event driven, Phase III study to assess the effects of [withheld]-064992 on Morbidity and Mortality in patients with Symptomatic Pulmonary Arterial Hypertension.

5. 5Title (diabetes mellitus)DiabetesDouble-blindPlacebo-controlledActive comparatorParallel-group

   A random, Double Blind, Placebo and Active Comparator Controlled parallel group research of the Revoclytoson safety and benefits in Monotherapy treatment type 2 of diabetes mellitus.

6. 6Title (type 2 Diabetes Mellitus)DiabetesRandomisedDouble-blindPlacebo-controlledActive comparator

   A randomized, double-blinded, placebo and active comparator-controlled, parallel group study to determine the efficacy and safety of Rivoglitazone as monotherapy treatment of type 2 Diabetes Mellitus with active comparator controlled optional 26-week extension period.

7. 7Asthma Research StudyRespiratoryThe triggers for your asthma symptoms are all around you—pets, pollen, pollution, and even people. What are you doing to stay in control? If you continue to experience attacks even though you take your medication as directed, you may want to consider volunteering for a clinical research study.

   The triggers for your asthma symptoms are all around you—pets, pollen, pollution, and even people. What are you doing to stay in control? If you continue to experience attacks even though you take your medication as directed, you may want to consider volunteering for a clinical research study.

8. 8A Clinical Research Study for Adults with Chronic AsthmaRespiratoryPatient has used medications with known activities as strong inhibitors or inducers of P-450 metabolism (e.g., phenobarbital, phenytoin, rifampin, trimethoprim/sulfamethoxazole, and ketoconazole [or other azoles]), 2 weeks prior to Visit 1, or plans to take such medications during the study. Patient has used any medication with a narrow therapeutic index (e.g., Warfarin, Coumadin, Dicoumarol, digoxin, Digitoxin) within 2 weeks prior to Visit 1 or plans to take such medications during the study.

   Patient has used medications with known activities as strong inhibitors or inducers of P-450 metabolism (e.g., phenobarbital, phenytoin, rifampin, trimethoprim/sulfamethoxazole, and ketoconazole [or other azoles]), 2 weeks prior to Visit 1, or plans to take such medications during the study. Patient has used any medication with a narrow therapeutic index (e.g., Warfarin, Coumadin, Dicoumarol, digoxin, Digitoxin) within 2 weeks prior to Visit 1 or plans to take such medications during the study.

9. 9Warfarin Information GuideCardiovascularWarfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners.

   Warfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners.

   One of the conditions for which warfarin is prescribed is to help prevent and treat blood clots associated with an irregular heartbeat called atrial fibrillation. Warfarin works by blocking the formation of clotting factors in the liver that are dependent on vitamin K.

   As a participant in the CV185030 clinical research trial, you have been assigned to 1 of 2 study treatment groups and you are currently taking study medication, either an investigational medication or warfarin. This study is being conducted "double-blind," which means neither you nor your study doctor will know if you are taking the investigational medication or warfarin, except in a medical emergency.

   In addition to your blinded study medication (investigational medication or warfarin), you are also taking a placebo (inactive pill).

   Since your study medication may include warfarin, you must follow the medication precautions and dietary rules as if you are taking warfarin. This Warfarin Information Guide is a helpful source to assist you during your participation in this study.

10. 10SERAPHIN-OL (pulmonary arterial hypertension)Pulmonary hypertensionOpen-labelSingle-armExtension study

    Study with an ERA in Pulmonary arterial Hypertension to Improve clinical outcome (Open Label) - Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of [withheld]-064992 in patients with symptomatic pulmonary arterial hypertension

11. 11Title (Type 2 Diabetes Mellitus)DiabetesRandomisedDouble-blindPlacebo-controlledActive comparator

    A Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus with an optional 26-Week Active Comparator-Controlled Extension Periods.

12. 12Title (Age-Related Macular Degeneration)OphthalmologyPhase IIIRandomisedDouble-maskedActive comparator

    [withheld] Pharmaceuticals, Inc., "A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects with Neovascular Age-Related Macular Degeneration" - You are being asked to take part in this research study because you have neovascular Age-Related Macular Degeneration (AMD). This study involves the use of an investigational drug called VEGF Trap-Eye. VEGF Trap-Eye has not been approved by the US Food and Drug Administration (FDA). Its use in this study is experimental. This study also involves the use of an FDA-approved drug called [withheld]® (ranibizumab). [withheld] Pharmaceuticals, Inc. sponsors this research study.

13. 13Title (non-small cell lung cancer)OncologyPhase IIb/IIIRandomisedDouble-blind

    Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib - You are being asked to join this research study because you have non-small cell lung cancer and your disease has progressed since receiving erlotinib ([withheld]®) or gefitinib ([withheld]®). Taking part in a research study is your choice. Important information about this research study is explained below. Please read this information carefully and ask as many questions as you like before you decide to join the study. [withheld] Pharmaceuticals, Inc. (BIPI) is the sponsor of this research study. BIBW 2992 is an investigational (experimental) drug which means that it has not been approved by the Food and Drug Administration (FDA) and it is not available to people who are not in research studies like this one. In this study, BIBW 2992 50 mg, will be compared to placebo. A placebo is an inactive substance. For this study the placebo will be an inactive pill and will look just like the BIBW 2992 pill.

14. 14Centrum Advantage®Consumer healthSpecially formulated to help prevent certain chronic illnesses; Contains lycopene (2 mg), lutein (2 mg), vitamin C (250 mg), vitamin D (800 IU), B12 (100 mcg) and selenium (70 mcg); Two tablets per day; Specially formulated for adults over 50. Helps maintain cardiovascular and eye health; Contains lycopene (600 mcg), lutein (500 mcg), vitamin D (600 IU), vitamin K (25 mcg), extra vitamin E and calcium; Lower level of iron; Also available in chewables; Centrum Select® - Specially formulated for adults over 50. Helps maintain cardiovascular and eye health; Contains lycopene (600 mcg), lutein (500 mcg), vitamin D (600 IU), vitamin K (25 mcg), extra vitamin E and calcium; Lower level of iron; Also available in chewables.

    Specially formulated to help prevent certain chronic illnesses; Contains lycopene (2 mg), lutein (2 mg), vitamin C (250 mg), vitamin D (800 IU), B12 (100 mcg) and selenium (70 mcg); Two tablets per day; Specially formulated for adults over 50. Helps maintain cardiovascular and eye health; Contains lycopene (600 mcg), lutein (500 mcg), vitamin D (600 IU), vitamin K (25 mcg), extra vitamin E and calcium; Lower level of iron; Also available in chewables; Centrum Select® - Specially formulated for adults over 50. Helps maintain cardiovascular and eye health; Contains lycopene (600 mcg), lutein (500 mcg), vitamin D (600 IU), vitamin K (25 mcg), extra vitamin E and calcium; Lower level of iron; Also available in chewables.

15. 15BRAIN FUNCTIONConsumer healthKey Beneficial Nutrients: B Vitamins, Vitamin C, Vitamin E and Niacinamide; BREAST HEALTH - Key Beneficial Nutrients: Vitamin D, Vitamin B6, Vitamin B12 and Folic Acid; COLON HEALTH - Key Beneficial Nutrients: Vitamin D and Folic Acid

    Key Beneficial Nutrients: B Vitamins, Vitamin C, Vitamin E and Niacinamide; BREAST HEALTH - Key Beneficial Nutrients: Vitamin D, Vitamin B6, Vitamin B12 and Folic Acid; COLON HEALTH - Key Beneficial Nutrients: Vitamin D and Folic Acid

16. 16Diabetes CareDiabetesFood Groups · Tips · Healthy choices · Limit or avoid

    Food Groups	Tips	Healthy choices	Limit or avoid
    Vegetables & Fruit	Vary your choices by selecting fruit and vegetables with various vibrant colours Keep the skin on your fruit and vegetables as it is an important source of fibre	Berries, figs, grapefruit, honeydew melon, nectarines, pears, tangerines Asparagus, broccoli, cabbage, cucumber, eggplant, green and yellow beans, spinach, tomatoes	Avocados and olives – they do contain important nutrients, but they are high in fat and should be limited to avoid weight gain Those prepared with added fat, sugar or salt
    Grain Products	Choose low-fat, whole grain foods as they are high in fibre	Whole grain bread, brown or wild rice, whole wheat pasta, bran based cereals, oatmeal, barley	High-fat choices such as muffins, cookies, croissants
    Milk & Alternatives	Choose low-fat where possible Replace high-fat choices such as ice cream with lower fat ice milk or frozen yogurt	Cottage cheese, skim milk, yogurt, soy milk	Butter and high-fat cheeses with saturated fats High-fat additions like cream or cheese based sauces
    Meat & Alternatives	Choose leaner meat Choose low-fat cooking methods such as broiling, baking or steaming	Lean meats, fish, eggs, dried beans, lentils, skinless turkey or chicken, tofu	High-fat meats such as bacon and sausage

17. 17Protocol Research Questionnaire excerptNeurologyOriginal documentA clinician-administered cognitive screening test covering orientation to time and place, word registration, and attention and calculation.

    

18. 18Title (Breast Cancer)OncologyPhase IIIRandomisedOpen-labelMulticentre

    A Phase III Open Label, Randomized Parallel Two-Arm Multi Center Study of E7389 versus 'Treatment of Physician's Choice' in Patients with Locally Recurrent or Metastatic Breast Cancer, Previously Treated with At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane - The purpose of this study is to compare the effectiveness of a new drug called Eribulin (also referred to as E7389) with existing, available treatments. The study involves female patients with locally advanced or metastatic breast cancer, whose disease has already progressed after treatment with drugs known as anthracyclines and taxanes. You may have received other treatments in addition to these. For this type of advanced cancer most of the available treatments have only limited activity so it is important to find new drugs.

19. 19Asthma Research StudyRespiratoryFacing an asthma attack can be frightening and dangerous until you regain control. If you continue to experience attacks even though you take your medication, you may want to consider volunteering for a clinical research study. This study is evaluating an investigational drug to see if it can help control your asthma symptoms when taken with your regular medication. As a qualified participant, you will receive all study-related care and study medication at no cost, and you may be compensated for time and travel. There are important things you should know about potential benefits and risks that the study doctor will explain to you.

    Facing an asthma attack can be frightening and dangerous until you regain control. If you continue to experience attacks even though you take your medication, you may want to consider volunteering for a clinical research study. This study is evaluating an investigational drug to see if it can help control your asthma symptoms when taken with your regular medication. As a qualified participant, you will receive all study-related care and study medication at no cost, and you may be compensated for time and travel. There are important things you should know about potential benefits and risks that the study doctor will explain to you.

20. 20Title (Renal Cell Carcinoma)OncologyA Randomized Trial of Temsirolimus and Sorafenib as Second-Line Therapy in Patients with Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy - The study doctor and Wyeth, the study sponsor, are studying sorafenib (Nexavar®) and temsirolimus (Torisel®). Both Nexavar® and Torisel® are drugs approved by the Food and Drug Administration (FDA) for treatment of advanced renal cell carcinoma (kidney cancer). You are being asked to take part in this study because you have been diagnosed with advanced kidney cancer, also known as metastatic renal cell carcinoma, and your disease condition got worse while you were being treated with Sutent®. The purpose of this study is to learn whether Torisel® and Nexavar® are safe and useful in treating advanced kidney cancer when given after treatment with Sutent® fails.

    A Randomized Trial of Temsirolimus and Sorafenib as Second-Line Therapy in Patients with Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy - The study doctor and Wyeth, the study sponsor, are studying sorafenib (Nexavar®) and temsirolimus (Torisel®). Both Nexavar® and Torisel® are drugs approved by the Food and Drug Administration (FDA) for treatment of advanced renal cell carcinoma (kidney cancer). You are being asked to take part in this study because you have been diagnosed with advanced kidney cancer, also known as metastatic renal cell carcinoma, and your disease condition got worse while you were being treated with Sutent®. The purpose of this study is to learn whether Torisel® and Nexavar® are safe and useful in treating advanced kidney cancer when given after treatment with Sutent® fails.

21. 21WARFARIN INFORMATION GUIDECardiovascularWarfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners. One of the conditions for which warfarin is prescribed is to help prevent and treat blood clots associated with an irregular heartbeat called atrial fibrillation. Warfarin works by blocking the formation of clotting factors in the liver that are dependent on vitamin K.

    Warfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners. One of the conditions for which warfarin is prescribed is to help prevent and treat blood clots associated with an irregular heartbeat called atrial fibrillation. Warfarin works by blocking the formation of clotting factors in the liver that are dependent on vitamin K.

22. 22Title (Diabetes Mellitus)DiabetesRandomisedDouble-blindPlacebo-controlledActive comparator

    A Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus with An Optional 26-Week Active Comparator-Controlled Extension Periods. Purpose - Rivoglitazone is an investigational drug. An investigational drug is a drug that is still being studied. It also means that it has not yet been approved by the U. S. Food and Drug Administration (FDA). The FDA allows rivoglitazone to be used only in research.

23. 23Pediatric Assent and Authorization Form (Lupus Nephritis)NephrologyPhase 2/3RandomisedDouble-blindPlacebo-controlled

    A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects with Class III or IV Lupus Nephritis in Combination with Mycophenolate Mofetil Therapy - If you say Yes to being in this study you will have to do certain things. You will need to take MMF and corticosteroids along with study drug. The study drug can either be the active drug or one that looks like the study drug but isn't active, called a placebo. The study drug will be given to you by injection under your skin, twice a week at first, then once a week for the rest of the study. These injections will hurt. You will have to come back to see the study doctor about 19 times in the next year and a half. We will ask you to tell us how you feel, what medicines you are taking, and if you are having any problems.

24. 24Title (Schizophrenia)PsychiatryOpen-labelRollover

    Otsuka Maryland Research Institute, Inc., "An Open-Label Rollover Study for Subjects with Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241" - The purpose of this study is to continue to provide ARIPIPRAZOLE therapy to adolescents or adults with schizophrenia completing the 31-03-241 study.

25. 25Title (Breast Cancer)OncologyPhase IIIRandomisedOpen-labelMulticentre

    A Phase III Open Label, Randomized Parallel Two-Arm Multi Center Study of E7389 versus 'Treatment of Physician's Choice' in Patients with Locally Recurrent or Metastatic Breast Cancer, Previously Treated with At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane.

26. 26Cardiovascular ResearchCardiovascularSTENTING AND ANGIOPLASTY WITH PROTECTION IN PATIENTS AT HIGH-RISK FOR ENDARTERECTOMY - You are being asked to participate in a patient registry, sponsored by [withheld], a [withheld] company, because your doctor has determined that you should receive a procedure called carotid stent supported angioplasty, and will use the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW) to perform this procedure. Angioplasty (a balloon catheter technique) is an effective method of opening the blood vessels in the neck, heart and legs. A stent is a metallic device that behaves like a spring to keep the artery open. The devices that will be utilized are the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW). The ECGW is a tiny filter basket at the end of the Guidewire in the shape of an umbrella intended to capture debris that might be released during the procedure and help reduce the chance of stroke. Both of these devices have been approved by the Food and Drug Administration (FDA). Other PRECISE® stents that are approved for use by the FDA in the future may also be used.

    STENTING AND ANGIOPLASTY WITH PROTECTION IN PATIENTS AT HIGH-RISK FOR ENDARTERECTOMY - You are being asked to participate in a patient registry, sponsored by [withheld], a [withheld] company, because your doctor has determined that you should receive a procedure called carotid stent supported angioplasty, and will use the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW) to perform this procedure. Angioplasty (a balloon catheter technique) is an effective method of opening the blood vessels in the neck, heart and legs. A stent is a metallic device that behaves like a spring to keep the artery open. The devices that will be utilized are the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW). The ECGW is a tiny filter basket at the end of the Guidewire in the shape of an umbrella intended to capture debris that might be released during the procedure and help reduce the chance of stroke. Both of these devices have been approved by the Food and Drug Administration (FDA). Other PRECISE® stents that are approved for use by the FDA in the future may also be used.

27. 27Sleep Evaluation Questionnaire (LSEQ)Sleep medicineOriginal documentThe Leeds Sleep Evaluation Questionnaire, answered on visual-analogue lines.

    

28. 28WARFARIN INFORMATION GUIDECardiovascularWarfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners.

    Warfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners.

29. 29AsthmaRespiratoryAsthma is a condition that affects the airways of the lungs leading them to become inflamed and swollen. It can affect adults and children of all ages. Approximately half of all individuals with asthma first experience symptoms before the age of ten.

    Asthma is a condition that affects the airways of the lungs leading them to become inflamed and swollen. It can affect adults and children of all ages. Approximately half of all individuals with asthma first experience symptoms before the age of ten.

    The condition is called non-allergic asthma when there is no obvious allergic cause. Asthma is more commonly experienced when an individual comes into contact with an allergen that he/she is sensitive to; this is called allergic asthma. Allergic asthma may account for up to nine out of ten of all asthma cases.

    What are the symptoms of asthma? - The following symptoms may be experienced with asthma: Difficulty breathing, Audible wheezing, A dry irritating cough, Chest tightness

30. 30TitlePsychiatryOpen-labelRollover

    [withheld] Research Institute, Inc., "an open-label rollover study for subjects suffering from schizophrenia and have completed the ABILIFY® (Aripiprazole) clinical study 31-03-241" - The purpose of this study is to continue to provide Aripiprazole therapy to teenagers or adults suffering from schizophrenia and have completed the 31-03-241 study.

31. 31TitleDiabetesPhase 2RandomisedDouble-blindPlacebo-controlled

    A double-blind, dose-ranging, placebo-controlled, randomized study to evaluate the safety and efficacy of INCB013739 plus metformin compared to metformin alone on glycemic control in type 2 diabetic subjects not adequately controlled by metformin monotherapy - This will be a double-blind, placebo controlled, randomized Phase 2 study to evaluate the efficacy, safety, and tolerability of INCB013739 when administered as an add-on to stable metformin therapy in patients with type 2 diabetes who are not adequately controlled by metformin alone. The Objectives of this study are to determine the effect of 12 weeks of treatment with INCB013739 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects

32. 32Patient Trials Identification CardOncologyOriginal documentAn emergency trial identification card with the patient name, study number and a note of the possible blinded treatments in a double-blind lung cancer study.

    

33. 33Study of the prevention of relapse in lymphomaOncologyPhase 3RandomisedDouble-blindPlacebo-controlled

    This study is a randomized, double-blind, placebo-controlled Phase 3 study to investigate the prevention of relapse in DLBCL using enzastaurin daily. This means participants will be assigned by chance to one of two treatment groups. One group will receive the investigational drug, and the other will receive placebo. Neither the medical personnel nor the patients will know who is receiving enzastaurin and who is receiving placebo. Twice as many patients will receive enzastaurin as placebo. Patients must enter the research study no later than 90 days either from the first day of the last cycle of R-CHOP therapy or from the last day of radiation therapy that was received as first-line treatment for DLBCL. Both enzastaurin and placebo are tablets and will be taken orally each day within 30 minutes of finishing a meal.

34. 34Patient's visit cardsPatient materialsOriginal documentA patient visit card giving the date of the next study visit, instructions for the three days before it, and boxes for recording the date and time of each dose of study medication.

    

35. 35Title (lung cancer)OncologyPhase IIb/IIIRandomisedDouble-blind

    Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib - You are being asked to take part in a research study involving the collection of tumor material from your biopsy and a sample of your blood for genetic research of your tissue. The genetic testing in this research is looking for EGFR mutation. EGF is a receptor that can be found on a cancer cell. When EGF is stimulated, the growth of cancer cells is accelerated. The main purpose of this study is to do laboratory tests on your tissue and blood sample to find out how the study drug may work, and to better understand why the study drug may work well in some patients but not others.

36. 36Blast Injuries: Essential FactsEmergency medicine3 original documentsBlast injuries fact list: lung injury.

    

37. 37Title (non-small cell lung cancer)OncologyPhase IIb/IIIRandomisedDouble-blind

    Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib - The purpose of this research study is to find out if the experimental drug, BIBW 2992, works better than placebo (inactive substance) in patients with advanced non-small cell lung cancer with progression of the cancer after being treated with erlotinib (Tarceva®) or gefitinib (IRESSA®). In addition to the study drug (BIBW 2992 or placebo) all subjects will be treated with best supportive care (BSC). Best Supportive Care is defined as psychological and nutritional support, the use of medicines for pain, infection, nausea or vomiting when needed, oxygen, blood transfusions and other treatments to manage your symptoms.

38. 38Asterand tissue research informed consent formBiobanking & geneticsThe purpose of this research study is to find new ways to identify and treat diseases. You are being asked to be in this study because of the tissue you may have removed during your surgery. Pathology will process these tissues to obtain a diagnosis. Any excess tissue not needed for diagnosis may be used for this study. This study does not require you to have any other surgery or to have any extra tissue removed. The tissue samples and medical data will be processed for Asterand, a for-profit biomedical research company. You may also be asked to provide blood samples for this study. Tissues, blood samples, and medical data will be sent to researchers at non-profit research centers and commercial companies. The samples and data may be used right away or may be stored indefinitely for future research.

    The purpose of this research study is to find new ways to identify and treat diseases. You are being asked to be in this study because of the tissue you may have removed during your surgery. Pathology will process these tissues to obtain a diagnosis. Any excess tissue not needed for diagnosis may be used for this study. This study does not require you to have any other surgery or to have any extra tissue removed. The tissue samples and medical data will be processed for Asterand, a for-profit biomedical research company. You may also be asked to provide blood samples for this study. Tissues, blood samples, and medical data will be sent to researchers at non-profit research centers and commercial companies. The samples and data may be used right away or may be stored indefinitely for future research.

39. 39Bipolar DisorderPsychiatryis a mood disorder that involves repeated episodes of mania and depression. A manic episode is a state during which your mood becomes exaggerated and you may experience increased energy and a decreased need to sleep. Although there's currently no cure for bipolar disorder, research is under way to find possible treatments to help control the manic episodes associated with the disease.

    is a mood disorder that involves repeated episodes of mania and depression. A manic episode is a state during which your mood becomes exaggerated and you may experience increased energy and a decreased need to sleep. Although there's currently no cure for bipolar disorder, research is under way to find possible treatments to help control the manic episodes associated with the disease.

40. 40Subject DiaryGastroenterologyPlease take your medication and complete your diary every morning upon waking. Complete your diary with the symptoms you had the day and night before. Complete one colored section per day. In the upper-right hand corner on the first fold out page of the diary please enter the date of the first time you took your medication. This date should match your first diary entry date. Complete the diary every day even if you did not have heartburn on the previous day.

    Please take your medication and complete your diary every morning upon waking. Complete your diary with the symptoms you had the day and night before. Complete one colored section per day. In the upper-right hand corner on the first fold out page of the diary please enter the date of the first time you took your medication. This date should match your first diary entry date. Complete the diary every day even if you did not have heartburn on the previous day.

41. 41Title (Hepatitis)HepatologyRandomisedPlacebo-controlledMulticentre

    A randomised, multi-centre, placebo-controlled study to assess the efficacy and safety of Eltrombopag in thrombocytopenic subjects with Hepatitis C (HCV) infection who are otherwise eligible to begin antiviral treatment (Peginterferon alfa-2b plus Ribavirin) – The [withheld] Department at this hospital is carrying out a clinical research study, sponsored by [withheld]. The aim of this study is to assess the safety and efficacy of Eltrombopag when used in patients who, like you, are infected with the hepatitis C virus and have a decreased platelet count (thrombocytopenia). For this reason, they cannot be given treatment for their infection with the hepatitis C virus. Platelets are blood cells that help to stop bleeding caused by a wound, such as a cut to the skin. Eltrombopag is a new drug that increases the number of platelets in the blood. You are being invited to participate in this study. It has been calculated that 750 patients will take part in this study. The study has been approved by the Research Ethics Committee of the [withheld] Hospital and by the Ministry of Health, and will be carried out in accordance with the ethical guidelines of the Helsinki Declaration and the requirements stipulated by the Royal Decree 223/2004.

42. 42Collecting Stool samplesGastroenterologyOriginal documentAn illustrated eight-step patient instruction sheet for collecting stool samples at home and returning them to the laboratory.

    

43. 43Warfarin information GuideCardiovascularWarfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners. One of the conditions for which warfarin is prescribed is to help prevent and treat blood clots associated with an irregular heartbeat called atrial fibrillation. Warfarin works by blocking the formation of clotting factors in the liver that are dependent on vitamin K.

    Warfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners. One of the conditions for which warfarin is prescribed is to help prevent and treat blood clots associated with an irregular heartbeat called atrial fibrillation. Warfarin works by blocking the formation of clotting factors in the liver that are dependent on vitamin K.

    As a participant in the CV185030 clinical research trial, you have been assigned to 1 of 2 study treatment groups and you are currently taking study medication, either an investigational medication or warfarin. This study is being conducted "double-blind," which means neither you nor your study doctor will know if you are taking the investigational medication or warfarin, except in a medical emergency.

    In addition to your blinded study medication (investigational medication or warfarin), you are also taking a placebo (inactive pill).

44. 44Patient Diary ExtractPatient materialsOriginal documentThe cover page of a patient's diary, with fields for the investigator, site, subject and medication numbers and the visit dates.

    

45. 45Title (Acute Rhinopharyngitis)RespiratoryOriginal documentEfficacy and tolerability of EPs® 7630 film-coated tablets in patients (≥18 years old) with Acute Rhinopharyngitis (ARP)

    Efficacy and tolerability of EPs® 7630 film-coated tablets in patients (≥18 years old) with Acute Rhinopharyngitis (ARP)

    

46. 46Title (acute rhinopharyngitis)RespiratoryEfficacy and tolerability of EPs® 7630 film-coated tablets in patients (≥ 18 years old) with acute rhinopharyngitis: The acute inflammation of nose and throat regions (acute rhinopharyngitis) with symptoms such as nasal congestion, runny nose, sore throat and headache, is one of the most common illnesses worldwide. Though mostly caused by viruses, these infections are often treated unnecessarily with antibiotics in the beginning stages. Therefore, alternative therapy concepts, e.g. therapy with herbals are desired both by doctors and patients. EPs® 7630 is an herbal extract prepared from the roots of Pelargonium sidoides (also known as "South African Geranium") in formulation of either solution or film-coated tablet. No animal substance is used in EPs® 7630 preparation and manufacturing process. Purpose of this clinical trial is to determine whether EPs® 7630 film-coated tablets possess a beneficial effect in the therapy of acute rhinopharyngitis (inflammation of nose and throat), as well as the safety and tolerability. A number of previous studies conducted in both adults and children (aged from one year old) have shown good safety and tolerability profile of EPs® 7630 in all age groups.

    Efficacy and tolerability of EPs® 7630 film-coated tablets in patients (≥ 18 years old) with acute rhinopharyngitis: The acute inflammation of nose and throat regions (acute rhinopharyngitis) with symptoms such as nasal congestion, runny nose, sore throat and headache, is one of the most common illnesses worldwide. Though mostly caused by viruses, these infections are often treated unnecessarily with antibiotics in the beginning stages. Therefore, alternative therapy concepts, e.g. therapy with herbals are desired both by doctors and patients. EPs® 7630 is an herbal extract prepared from the roots of Pelargonium sidoides (also known as "South African Geranium") in formulation of either solution or film-coated tablet. No animal substance is used in EPs® 7630 preparation and manufacturing process. Purpose of this clinical trial is to determine whether EPs® 7630 film-coated tablets possess a beneficial effect in the therapy of acute rhinopharyngitis (inflammation of nose and throat), as well as the safety and tolerability. A number of previous studies conducted in both adults and children (aged from one year old) have shown good safety and tolerability profile of EPs® 7630 in all age groups.

47. 47Disclosure of Medical InformationPatient rights & privacyI authorize the above-named source to release or disclose the following information: Any medical records or other information regarding my treatment, hospitalization, and/or outpatient care for my condition(s), including psychological or psychiatric condition(s), alcohol and/or drug abuse, or any HIV-related information. (In accordance with Federal confidentiality rules (42 CFR Part 2), State Mental Health Procedures Act and Act 148)

    I authorize the above-named source to release or disclose the following information: Any medical records or other information regarding my treatment, hospitalization, and/or outpatient care for my condition(s), including psychological or psychiatric condition(s), alcohol and/or drug abuse, or any HIV-related information. (In accordance with Federal confidentiality rules (42 CFR Part 2), State Mental Health Procedures Act and Act 148)

48. 48Title (lung cancer)OncologyPhase IIb/IIIRandomisedDouble-blind

    Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib: You are being asked to take part in a research study involving the collection of tumor material from your biopsy and a sample of your blood for genetic research of your tissue. The genetic testing in this research is looking for EGFR mutation. EGF is a receptor that can be found on a cancer cell. When EGF is stimulated, the growth of cancer cells is accelerated. The main purpose of this study is to do laboratory tests on your tissue and blood sample to find out how the study drug may work, and to better understand why the study drug may work well in some patients but not others.

49. 49National Marrow Donor ProgramPatient rights & privacyOriginal documentA statement of what research participants should be told before agreeing to take part in a study, and of their right to leave it at any time.

    

50. 50Title (Multiple Sclerosis)NeurologyRandomisedDouble-blindPlacebo-controlledDose-comparison

    A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis: The purpose of this study is to find out if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to find out if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for your disease to get worse. The safety of BG00012, how well you tolerate it, and the effect it may have on tests and evaluations used to assess MS are also goals of this study.

51. 51Title (Disseminated Intravascular Coagulation)HaematologyPhase 2bRandomisedDouble-blindPlacebo-controlled

    A Randomized, Double-Blind, Placebo-Controlled, Phase-2b Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation: This study will involve an experimental drug called ART-123 that is used for the treatment of subjects like you who have DIC and sepsis. An experimental drug is one that has not been approved by the U.S. Food and Drug Administration (FDA) or by the national health authority in your country. (Note: ART-123 was recently approved in Japan for treatment of DIC.) ART-123 is a protein called thrombomodulin that stops blood from clotting and prevents the loss of platelets from the blood.

52. 52Title (Major Depressive Disorder)PsychiatryRandomisedDouble-blindPlacebo-controlledFixed-dose

    A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder: You are being asked to take part in a research study sponsored by [withheld] Research & Development Centre (Europe) Ltd. The purpose of this study is to assess the effectiveness, safety, and tolerability of 3 different doses of the study drug, Lu AA21004 (1 mg, 5 mg and 10 mg) compared with placebo (a non-active drug/a "dummy" drug). The placebo will be a look-alike drug that has no active drug in it.

53. 53[withheld] DNA Banking ProgramBiobanking & geneticsWhen you're sick, you want a medicine that works quickly and effectively to make you feel better and help fix whatever is wrong. To make sure that's just what you get, researchers are working hard to understand how to make medicines that can help the greatest number of people possible. Because even though our bodies are 99 percent the same, we have small differences that make us individuals – our genes – and those genes affect how medicines work inside us. The material inside our genes, DNA, is as unique as you are. Right now, researchers are studying DNA from people around the world to help them develop better medicines. Right now, they're asking people just like you to help.

    When you're sick, you want a medicine that works quickly and effectively to make you feel better and help fix whatever is wrong. To make sure that's just what you get, researchers are working hard to understand how to make medicines that can help the greatest number of people possible. Because even though our bodies are 99 percent the same, we have small differences that make us individuals – our genes – and those genes affect how medicines work inside us. The material inside our genes, DNA, is as unique as you are. Right now, researchers are studying DNA from people around the world to help them develop better medicines. Right now, they're asking people just like you to help.

    As part of a [withheld] sponsored clinical trial, you have the opportunity to provide a sample of your DNA to help in this important research program. It's as simple as collecting an extra tube of blood. From that blood, scientists will collect the DNA and it will become part of a DNA bank that they will use for research.

54. 54NHS Care Records ServicePatient rights & privacyOriginal documentThe introduction to a patient leaflet about the information held in health records and how it will be accessed under the NHS Care Records Service.

    

55. 55Title (Atrial Fibrillation)CardiovascularPhase IIIRandomisedDouble-blindDouble-dummy

    A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects with Atrial Fibrillation – Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation (ENGAGE – AF): You are being asked to participate in a clinical study for a condition called Atrial Fibrillation. Atrial fibrillation (AF) is an abnormal heart rhythm which results in irregular heart beats. AF is the most common type of arrhythmia (a change in the rhythm of your heartbeat) in adults and becomes more common with increased age. Patients with AF are at increased risks for thromboembolic (blood clots) disease. Sometimes clots can break away and travel through the major blood vessels and the chamber of the heart eventually blocking smaller vessels throughout the body. The condition that occurs when a blood clot blocks smaller blood vessels in the brain is known as a stroke.

56. 56Title (Crohn's Disease)GastroenterologyPhase 3RandomisedBlindedPlacebo-controlled

    A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn's Disease: You are being asked to participate in this research study because you have been diagnosed with moderate to severe Crohn's Disease (CD) and have not responded well to at least one other therapy. In this study, an investigational drug called MLN0002 will be tested to see if it is effective in treating CD. MLN0002 is a monoclonal antibody and works by attaching itself to a particular kind of white blood cell and reducing inflammation. The term "monoclonal" refers to the fact that it is produced in a laboratory. MLN0002 is a new type of investigational drug that is being developed by scientists at Millennium, the sponsor of this study. The term "investigational" means that the drug is still being tested and is not approved for sale in (specify appropriate country/regulatory body).

    The main purpose of this study is to find out whether treatment with MLN0002 is effective and safe in treating your CD.

57. 57Trans FatsConsumer healthOriginal documentA consumer health leaflet, "Top 5 Things You Need to Know about Trans Fat", in question-and-answer form.

    

58. 58Protocol TitleOncologyReview of Tasigna dosing regimens and patient compliance in ENACT patients with imatinib-resistant / intolerant Ph+ CML CP or AP when transitioned from Glivec (imatinib) to Tasigna (nilotinib)

    Review of Tasigna dosing regimens and patient compliance in ENACT patients with imatinib-resistant / intolerant Ph+ CML CP or AP when transitioned from Glivec (imatinib) to Tasigna (nilotinib)

59. 59Protocol Title (Ulcerative Colitis)GastroenterologyPhase 3RandomisedBlindedPlacebo-controlled

    A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis: We are inviting you to participate in an optional study to collect blood for DNA research. Segments of the DNA called genes are responsible for passing particular traits such as eye color from parents to children. Just as some genes control eye and hair color, others affect the chances that we will get certain diseases or the way that our bodies respond to medicines. DNA analysis may predict how long a medicine stays in your body, whether you are likely to benefit from a drug, or whether you are likely to have a side effect from a particular drug. Your participation in this research is limited to only the requirement that the study doctor or personnel collect a sample of your blood for DNA one time. You do not need to participate in this optional study to participate in the main study, C13006. If you decide not to participate in this optional study and have a blood sample collected and stored for research, this will have no effect on your participation in Study C13006.

60. 60Title (MRI/Scan – Multiple Sclerosis)NeurologyDouble-blindPlacebo-controlledParallel-groupMulticentre

    A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis: The purpose of the Site Procedure Manual is to describe the process and procedures that will be used to assess site image quality, ensure that all sites use a standard subject prep and imaging format for the study and to outline how the imaging media will be sent to BMS for processing and analysis. An abdominal ultrasound to examine the pancreas will be performed at screening and every 24 weeks of the treatment period, and at end of study. The ultrasound examination will be performed according to local standards and will involve a local qualified expert (i.e. Gastroenterologist) to provide a final interpretation and report, if necessary. The findings will be captured in the Case Report Form (CRF). All reports with abnormal findings will be collected with the CRF (and translated into English as applicable).

    All ultrasounds with abnormal pancreatic findings must be followed by a Computed Tomography (CT) scan with contrast, or Magnetic Resonance Imaging (MRI) of the pancreas. These MRI and CT scan images must be forwarded to Biomedical Systems, the central reading center. The central CT scan/MRI reading results will be sent in parallel to the investigator, the Sponsor's medical expert and/or designee. Any pancreatic abnormality detected by CT scan or MRI should be reported as an alert term for expedited reporting to the sponsor's safety officer and as an Adverse Event (AE) or Serious Adverse Event (SAE), as per investigator judgment. In addition, the Independent Data Monitoring Committee (IDMC) expert will receive reports of any pancreatic abnormalities detected by CT scan or MRI and will provide the investigator with a clinical assessment of these cases.

61. 61Title (Influenza)VaccinesPhase IIIRandomisedDouble-blindActive comparator

    Randomized, double blind, active-controlled, multi-national, phase Ⅲ study to evaluate the effectiveness (immunogenicity) and safety of GC501 (influenza split vaccine) administered intramuscularly in healthy children aged from 6 months to < 18 years: 'GC501' developed by [withheld] Inc. is a fertile egg-derived influenza split vaccine that includes 3 types of inactivated influenza virus recommended by WHO for 2007-2008 or 2008-2009 season. 'GC501' was verified not to cause toxic findings, as evidenced by the result of a one time administration toxicity test and 4-week (1 per 2 weeks total of 2 intramuscular injections over 4 week period) and 6-week (1 per 2 weeks total of 3 intramuscular injections over 6 week period) repetitive administration toxicity test both performed using rats. Also, the final product drug of 'GC501' has been preceded by a 6-week long-term preservation test in 2~8°C and it was concluded that it is found suitable for stability study item standards.

62. 62Meningococcal ImmunizationVaccinesMeningococcal disease is any infection caused by bacteria called meningococci (muhnin-jo-cox-eye). This infection most often leads to severe swelling around the lining of the brain and spinal cord (meningitis) or infection of the bloodstream (meningococcemia). Less often, it leads to other less severe illnesses, like arthritis and pneumonia. Meningococcal disease is very serious. Even with treatment, approximately one out of every ten people who get it will die. And about two in ten survivors will have permanent problems including brain damage, hearing loss and limb amputations. The early symptoms of meningococcal disease can include fever, headache, body aches and a stiff neck. Because these early symptoms may be mild and similar to those of less serious viral illnesses like a cold or the flu, it would not be unusual for a person to delay seeking treatment. But symptoms can progress very fast, killing an otherwise healthy young person in 48 hours or less, so it is critical to seek medical attention quickly. Other symptoms that also may occur are nausea, vomiting, confusion, sleepiness, sensitivity to light and a rash (usually dark purple spots on the arms or legs).

    Meningococcal disease is any infection caused by bacteria called meningococci (muhnin-jo-cox-eye). This infection most often leads to severe swelling around the lining of the brain and spinal cord (meningitis) or infection of the bloodstream (meningococcemia). Less often, it leads to other less severe illnesses, like arthritis and pneumonia. Meningococcal disease is very serious. Even with treatment, approximately one out of every ten people who get it will die. And about two in ten survivors will have permanent problems including brain damage, hearing loss and limb amputations. The early symptoms of meningococcal disease can include fever, headache, body aches and a stiff neck. Because these early symptoms may be mild and similar to those of less serious viral illnesses like a cold or the flu, it would not be unusual for a person to delay seeking treatment. But symptoms can progress very fast, killing an otherwise healthy young person in 48 hours or less, so it is critical to seek medical attention quickly. Other symptoms that also may occur are nausea, vomiting, confusion, sleepiness, sensitivity to light and a rash (usually dark purple spots on the arms or legs).

63. 63Title (Multiple Sclerosis)NeurologyRandomisedDouble-blindPlacebo-controlledDose-comparison

    A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis: The purpose of this study is to find out if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to find out if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for your disease to get worse. The safety of BG00012, how well you tolerate it, and the effect it may have on tests and evaluations used to assess MS are also goals of this study.

64. 64Title (Ulcerative Colitis)GastroenterologyPhase 3RandomisedBlindedPlacebo-controlled

    A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis: The main purpose of this study is to find out whether treatment with MLN0002 is effective and safe in treating your UC

65. 65Title (Diabetes)DiabetesRandomisedDouble-blindPlacebo-controlledDose-ranging

    A double-blind, dose-ranging, placebo-controlled, randomized study to evaluate the safety and efficacy of INCB013739 plus metformin compared to metformin alone on glycemic control in type 2 diabetic subjects not adequately controlled by metformin monotherapy: The purpose of doing the optional examination is to understand how the study drug, INCB013739 affects the body's production of glucose and insulin by performing Cortrosyn stimulation tests. ACTH and Cortrosyn stimulation test measures the ability of the adrenal glands (a gland located on top of the kidneys) to respond to adrenocorticotropic hormone (ACTH) by producing cortisol appropriately. ACTH is a hormone produced in the pituitary gland (a small gland at the base of the brain) that stimulates the adrenal glands. In turn, the adrenal glands then make a hormone called cortisol. Cortisol is a hormone that helps control the heart rate, blood pressure, the way the body uses food, and other vital functions which helps your body manage stress.

66. 66Title (Atrial Fibrillation)CardiovascularPhase IIIRandomisedDouble-blindDouble-dummy

    A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects with Atrial Fibrillation – Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation: You are being asked to participate in a clinical study for a condition called Atrial Fibrillation. Atrial fibrillation (AF) is an abnormal heart rhythm which results in irregular heart beats. AF is the most common type of arrhythmia (a change in the rhythm of your heartbeat) in adults and becomes more common with increased age. Patients with AF are at increased risks for thromboembolic (blood clots) disease. Sometimes clots can break away and travel through the major blood vessels and the chamber of the heart eventually blocking smaller vessels throughout the body. The condition that occurs when a blood clot blocks smaller blood vessels in the brain is known as a stroke. Patients with AF are often on long-term blood-thinning drugs such as warfarin also known as coumadin to help prevent clots from forming. Warfarin and other blood thinners that are presently being used are effective but require certain food restrictions and monthly blood monitoring. The pharmaceutical company Daiichi Sankyo is developing a new blood thinner, DU-176b, which does not have food interactions and does not require monthly blood monitoring.

67. 67Clinical Study Visit Chart/Visit GuidePatient materials2 original documentsAn illustrated guide to the study procedures, including medical history, physical and psychological examination, fasting blood tests, vital signs, urine tests and an ECG.

    

68. 68Type-2 Diabetes Clinical Research StudyDiabetes2 original documentsA one-page summary of a phase III type 2 diabetes study: its objectives, design, three treatment groups and eligibility criteria.

    

69. 69Intraosseous InfusionEmergency medicine3 original documentsTitle page of the directions for use for an intraosseous infusion system.

    

70. 70Optimizing your HIV therapy through [withheld]HIVThis booklet has been developed to answer some of the common questions you may have about taking [withheld] therapy. While we hope it will be a good source of information, it will not tell you everything about [withheld]. If you have further questions about [withheld] or any other part of your HIV treatment, please be sure to talk to your doctor, nurse or pharmacist.

    This booklet has been developed to answer some of the common questions you may have about taking [withheld] therapy. While we hope it will be a good source of information, it will not tell you everything about [withheld]. If you have further questions about [withheld] or any other part of your HIV treatment, please be sure to talk to your doctor, nurse or pharmacist.

    You will find a notes section at the end of this booklet where you can jot down any questions you may have. If you happen to experience any serious side effects, or if you notice any side effects not listed in this booklet, please tell your doctor, nurse or pharmacist.

    Like all medicines, [withheld] has been prescribed specifically for you and your particular condition. It is very important that you do not share it with other people, as it may harm them, even if their symptoms are the same as yours.

    What is [withheld]?

    [withheld] is an oral tablet used for the treatment of HIV-1 (Human Immunodeficiency Virus type 1) infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). [withheld] is a type of anti-HIV drug referred to as a CCR5 antagonist. It must be taken in combination with other HIV drugs to provide the maximum benefit to you.

    What can [withheld] do for me?

    [withheld] can reduce the amount of HIV in the blood (called "viral load") and increase the number of CD4 (T) cells. This may keep your immune system healthy, so it can help fight infection.

    Like all current HIV therapies, [withheld] does not cure HIV infection or AIDS. People taking [withheld] may still develop infections or other conditions associated with HIV infection. Although [withheld] is not a cure for HIV or AIDS, it can help reduce your risks of getting illnesses associated with HIV infection (AIDS and opportunistic infection).

    Can I still pass on the HIV virus if I am taking [withheld]?

    While [withheld] can lower the amount of HIV virus in your blood, you can still pass on the virus to other people through sexual contact, sharing needles or other contact with your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom. This will lower the chance of contact with any body fluids such as semen, vaginal secretions or blood. To avoid passing on the HIV virus should you use intravenous medications or street drugs, you must never re-use or share needles.

    How does [withheld] work?

    HIV enters a type of blood cell called the CD4+ or T-cells by attaching to a receptor on the outside of the cell. These receptors are called CCR5 or CCXCR4. [withheld] works by blocking the CCR5 receptor, so that it is not available for the HIV virus to use to get inside the blood cell. The type of HIV virus that uses this receptor is called CCR5-tropic HIV. Your doctor may take blood samples to determine if you have been infected with CCR5-tropic HIV in which case [withheld] may be an appropriate treatment for you.

71. 71Patient DiaryRespiratoryOriginal documentA morning and evening patient diary page recording rescue medication use, symptoms, cough, wheeze, sputum and breathlessness on 0 to 3 scales.

    

72. 72Diabetes BrochureDiabetesOriginal documentA brochure inviting people whose type 2 diabetes is not controlled by metformin to take part in a study, with the eligibility criteria.

    

73. 73Clinical Trial Questionnaire ExcerptNeurologyOriginal documentQuestionnaire items on a patient's first hospital stay for stroke: living arrangement and employment before admission, nights spent in each ward, and discharge destination.

    

74. 74Title (Dengue Fever)VaccinesImmunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore (CYD28): Dengue is a disease caused by a virus that is spread by mosquito bites. People who catch dengue virus can get dengue fever, meaning that they will have high fever (up to 40°C for 3 to 7 days), often with severe headache, muscle and joint pains, pain behind the eyes, and skin rash. Dengue disease is sometimes more severe and can cause bleeding of the internal organs and a sudden decrease of the blood pressure (shock). Dengue can cause death in some cases, mainly in children. The purpose of this study is to evaluate the immunogenicity and safety of a new vaccine against dengue. "Immunogenicity" means the ability of the vaccine to stimulate the body to develop a defense mechanism against the disease, and "safety" means the way the vaccine is tolerated. The vaccine contains the four dengue serotypes.

    Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore (CYD28): Dengue is a disease caused by a virus that is spread by mosquito bites. People who catch dengue virus can get dengue fever, meaning that they will have high fever (up to 40°C for 3 to 7 days), often with severe headache, muscle and joint pains, pain behind the eyes, and skin rash. Dengue disease is sometimes more severe and can cause bleeding of the internal organs and a sudden decrease of the blood pressure (shock). Dengue can cause death in some cases, mainly in children. The purpose of this study is to evaluate the immunogenicity and safety of a new vaccine against dengue. "Immunogenicity" means the ability of the vaccine to stimulate the body to develop a defense mechanism against the disease, and "safety" means the way the vaccine is tolerated. The vaccine contains the four dengue serotypes.

75. 75Epinephrine auto-injectorEmergency medicineYou, or someone you care for, have been prescribed the Twinject epinephrine auto-injector, an emergency response treatment for severe allergic reactions. (The medical term for this is anaphylaxis.) This booklet will help to give you a better understanding of your allergy, and the emergency response treatment provided by your Twinject. You'll also learn about the Twinject 'Be Ready' Program, providing you and people you know with wide-reaching emergency treatment support.

    You, or someone you care for, have been prescribed the Twinject epinephrine auto-injector, an emergency response treatment for severe allergic reactions. (The medical term for this is anaphylaxis.) This booklet will help to give you a better understanding of your allergy, and the emergency response treatment provided by your Twinject. You'll also learn about the Twinject 'Be Ready' Program, providing you and people you know with wide-reaching emergency treatment support.

    What is anaphylaxis? It is a severe allergic reaction that can affect many body systems – upper and lower respiratory, skin, cardiovascular, and gastrointestinal. Anaphylaxis is an overreaction of the body's immune system by triggering allergen (the substance you are allergic to). It usually occurs soon after exposure, and can be mild to life-threatening. It may subside quickly with treatment, require more than one dose of epinephrine to manage, or reoccur, usually 1 to 8 hours later. Anaphylaxis requires immediate attention and treatment.

76. 76Typical Medical TerminologyMedical terminologyBrain and Spinal Cord · Anatomy of the Ear · DNA and Chromosomes · Brachytherapy · Normal vs. Cancer Cell · Neuron with Schwann Cell Covering · Female Reproductive System · Heart with Valves · Heart · Organs of the Thorax · Closed Head Injury · Deep Vein Thrombosis · Lung Mass with Thoracotomy and Biopsy · Surgical Bowel Resection and Colostomy · Acute Peritonitis · Perforation of Colon (Perforated Bowel) · MRI of the Head and Neck · Percutaneous Endoscopic Gastrostomy (PEG) Procedure · Median Episiotomy vs. Mediolateral Episiotomy · Ovarian (Ovary) Mass · Anatomy of the Adrenal Glands · Vitamin D Resistant Rickets with Bilateral Femur Fractures · Septic Surgical Wound Following Abdominal Surgery · Post-accident Shoulder Injuries · Progression of Breast Mass · Bowel Obstruction (Blocked Colon) · Breast Reduction Surgery · Lumbar Spine Injuries with Decompression Surgery · Classification of Skin Burns

    • ›Brain and Spinal Cord
    • ›Anatomy of the Ear
    • ›DNA and Chromosomes
    • ›Brachytherapy
    • ›Normal vs. Cancer Cell
    • ›Neuron with Schwann Cell Covering
    • ›Female Reproductive System
    • ›Heart with Valves
    • ›Heart
    • ›Organs of the Thorax
    • ›Closed Head Injury
    • ›Deep Vein Thrombosis
    • ›Lung Mass with Thoracotomy and Biopsy
    • ›Surgical Bowel Resection and Colostomy
    • ›Acute Peritonitis
    • ›Perforation of Colon (Perforated Bowel)
    • ›MRI of the Head and Neck
    • ›Percutaneous Endoscopic Gastrostomy (PEG) Procedure
    • ›Median Episiotomy vs. Mediolateral Episiotomy
    • ›Ovarian (Ovary) Mass
    • ›Anatomy of the Adrenal Glands
    • ›Vitamin D Resistant Rickets with Bilateral Femur Fractures
    • ›Septic Surgical Wound Following Abdominal Surgery
    • ›Post-accident Shoulder Injuries
    • ›Progression of Breast Mass
    • ›Bowel Obstruction (Blocked Colon)
    • ›Breast Reduction Surgery
    • ›Lumbar Spine Injuries with Decompression Surgery
    • ›Classification of Skin Burns

77. 77Title (Atrial Fibrillation)CardiovascularPhase IIIRandomisedDouble-blindDouble-dummy

    A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects with Atrial Fibrillation - Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation: Scientists do research to understand how our genes affect our features and health. Our genes are the things which make each one of us unique. They control many factors that make us who we are. Scientists now are working to understand if genes control whether we are more likely to have an adverse drug reaction or develop certain diseases. Genes are made up of DNA. DNA contains the bits of information that directs your body to perform all of its vital functions. Genetic research (that is research on genes) includes studying DNA to better understand how the body works.

78. 78Title (COPD)RespiratoryRandomisedDouble-blindPlacebo-controlledDouble-dummy

    A randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL (5 μg [2 actuations of 2.5 μg] and 10 μg [2 actuations of 5 μg]) delivered by the [withheld]® Inhaler, and 48 weeks of twice daily [withheld]® (12 μg) delivered by the [withheld]® Inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD): The purpose of this study is to determine how safe and effective an investigational drug called "BI 1744 CL" is when taken for a long period of time by patients with COPD. The BI 1744 CL will be given using a new inhaler called the [withheld]®. The [withheld]® is different from inhalers that are currently available. It delivers a slow-moving mist of medicine that is easy to inhale and travels deep into the lungs, where it may work better. The [withheld]® is environmentally friendly as it is not operated by propellants such as CFC-gases.

79. 79Deep vein Thrombosis StudyCardiovascularOriginal documentAn information sheet on a deep vein thrombosis prevention study: study medications, eligibility requirements and participation.

    

80. 80Patient Instruction SheetPatient materialsOriginal documentPatient instructions and restrictions for the days before treatment, and the hour-by-hour procedures on the first treatment day.

    

81. 81TitleDiabetesIs There a Way to Improve the Glucose Screening Test in Pregnant Women?: Study Purpose - The purpose of this research study is to find a way to make the usual sugar testing in pregnancy more accurate and reduce the number of repeat tests. Participants will be asked to have their usual sugar test done either on an empty stomach or after breakfast.

    Is There a Way to Improve the Glucose Screening Test in Pregnant Women?: Study Purpose - The purpose of this research study is to find a way to make the usual sugar testing in pregnancy more accurate and reduce the number of repeat tests. Participants will be asked to have their usual sugar test done either on an empty stomach or after breakfast.

    risks and benefits - If you participate in this study you may be able to avoid having to repeat a sugar test that has come back abnormal. Participating in this study will not expose you or your baby to any extra risks. If you have the test done on an empty stomach, you may have some slight discomfort from being hungry. Participation in this study may require an extra hour of your time.

82. 82Hepatitis BrochureHepatologyOriginal documentA recruitment brochure for a worldwide chronic hepatitis B study, with the criteria for taking part.

    

83. 83Thrombosis/Embolism brochuresCardiovascular2 original documentsA patient brochure on deep vein thrombosis and pulmonary embolism in hospitalised patients, and the risk factors for both.

    

84. 84Title (Intra-abdominal Infections)Infectious diseaseRandomisedDouble-blindMulticentre

    A prospective, multicenter, double-blind, randomized, comparative study to estimate the safety, tolerability and efficacy of NXL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections (cIAI) in hospitalized adults: You have a complicated intra-abdominal infection. Researchers want to find out if an investigational drug called NXL104 in combination with other antibiotics can help people with complicated intra-abdominal infections. NXL104 is an investigational drug. An "investigational drug" is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). NXL104 is intended to stop the effect of some specific enzymes that bacteria produce that can make antibiotics less effective. Therefore, NXL104 is intended to be given in combination with other antibiotics. This study will test an investigational combination of NXL104 with ceftazidime and metronidazole. Ceftazidime and metronidazole are approved (standard) antibiotics used to treat infections. However, the combination of NXL104 with ceftazidime and metronidazole is investigational. An "investigational combination" is a combination that is being tested and is not approved for complicated intra-abdominal infections by the U.S. Food and Drug Administration (FDA).

85. 85Title (Hepatitis-B)HepatologyPhase 3bRandomisedDouble-blindDouble-dummy

    A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects with Chronic Hepatitis B who are Resistant to Lamivudine: The purpose of this study is to compare the safety, tolerability and effectiveness of 240 weeks of treatment with tenofovir DF 300 mg once daily (QD) by itself versus tenofovir DF 300 mg plus emtricitabine 200 mg (both taken once daily as a single, fixed-dose combination pill) in patients who are resistant to lamivudine (a drug approved for the treatment of chronic hepatitis B in your country).

86. 86Patient Instruction SheetPatient materialsOriginal documentA patient instruction sheet listing restrictions during the treatment phase and in the three days before treatment.

    

87. 87Title (Rheumatoid Arthritis)RheumatologyRandomisedDouble-blindPlacebo-controlledDose-ranging

    A multi-centre randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy and immunogenicity of ART621 following multiple dose administration for 3 months in patients with rheumatoid arthritis concomitantly taking methotrexate: To find out if different doses of the experimental drug (ART621) can be used safely with methotrexate by rheumatoid arthritis patients. Your vital signs (blood pressure, pulse, and temperature), an electrocardiogram (test to measure the heart's electrical activity), blood and urine will be analysed in addition to physical examination and information on how you are feeling including any side effects you may be experiencing to determine safety of the experimental drug. We will also check your rheumatoid arthritis to see if there is any change to your condition. Participants will receive different doses of the experimental drug or placebo (no treatment) to determine effectiveness of the various drugs strengths. All participants will receive methotrexate.

88. 88Health/Wellbeing questionnaire ExcerptsPatient materials2 original documentsThe opening questions of a general health and well-being survey, rated from excellent to poor.

    

89. 89Heart and Stroke Foundation/Trans-FatsConsumer healthIndustrially-produced trans fat is formed during hydrogenation, a process used by the food industry to harden and stabilize liquid vegetable oils. Industrially-produced trans fat is more harmful to heart health than any other fat. Industrially-produced trans fat both increases the risk of heart disease by raising "bad" (LDL) cholesterol and lowering "good" (HDL) cholesterol, both of which are risk factors for cardiovascular disease. Trans fat also occurs naturally in some meats (e.g. beef and lamb) and dairy products. The Heart and Stroke Foundation is supporting the food service industry to restrict trans fat and saturated fat in food products to help reduce the risk of heart disease and stroke in British Columbians. The BC Government and Heart and Stroke Foundation of BC & Yukon are working together to support the BC food industry in restricting industrially-produced trans fat.

    Industrially-produced trans fat is formed during hydrogenation, a process used by the food industry to harden and stabilize liquid vegetable oils. Industrially-produced trans fat is more harmful to heart health than any other fat. Industrially-produced trans fat both increases the risk of heart disease by raising "bad" (LDL) cholesterol and lowering "good" (HDL) cholesterol, both of which are risk factors for cardiovascular disease. Trans fat also occurs naturally in some meats (e.g. beef and lamb) and dairy products. The Heart and Stroke Foundation is supporting the food service industry to restrict trans fat and saturated fat in food products to help reduce the risk of heart disease and stroke in British Columbians. The BC Government and Heart and Stroke Foundation of BC & Yukon are working together to support the BC food industry in restricting industrially-produced trans fat.

90. 90Cardiac Stent deviceCardiovascularOut-of-Scope Follow-up Study to Evaluate the Safety and Efficacy of the Neovasc Reducer: About 3 years ago you participated in a clinical study in which a stent-like device (Neovasc Reducer) was implanted in your heart. The goal of this study was to evaluate the safety and efficacy of this device. In this study your status was evaluated throughout the 6 months following the implantation. Since the termination of the study follow-up period no clinical evaluation of your angina status was performed. Therefore, now, 3 years following the implantation of this device, we wish to evaluate its long term clinical effect.

    Out-of-Scope Follow-up Study to Evaluate the Safety and Efficacy of the Neovasc Reducer: About 3 years ago you participated in a clinical study in which a stent-like device (Neovasc Reducer) was implanted in your heart. The goal of this study was to evaluate the safety and efficacy of this device. In this study your status was evaluated throughout the 6 months following the implantation. Since the termination of the study follow-up period no clinical evaluation of your angina status was performed. Therefore, now, 3 years following the implantation of this device, we wish to evaluate its long term clinical effect.

91. 91Bone Marrow RegistryHaematologyEvery day, thousands of patients with leukemia and other life-threatening diseases hope for a marrow donor who can make their transplant possible. Seventy percent of patients do not have a donor in their family. They depend on people like you.

    Every day, thousands of patients with leukemia and other life-threatening diseases hope for a marrow donor who can make their transplant possible. Seventy percent of patients do not have a donor in their family. They depend on people like you.

92. 92Swine Flu (Adapted from the Centers for Disease Control and Prevention)Infectious diseaseSwine Influenza (swine flu) is a respiratory disease of pigs caused by type A influenza viruses. Outbreaks of swine flu happen regularly in pigs. People do not normally get swine flu, but human infections can and do happen. Most commonly, human cases of swine flu happen in people who are around pigs but it's possible for swine flu viruses to spread from person to person also. Signs and symptoms of swine flu in people - The symptoms of swine flu in people are similar to the symptoms of regular human flu and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with swine flu. In the past, severe illness (pneumonia and respiratory failure) and deaths have been reported with swine flu infection in people. Like seasonal flu, swine flu may cause a worsening of underlying chronic medical conditions. Symptoms: Difficulty breathing or shortness of breath; Pain or pressure in the chest or abdomen; Sudden dizziness; Confusion; Severe or persistent vomiting.

    Swine Influenza (swine flu) is a respiratory disease of pigs caused by type A influenza viruses. Outbreaks of swine flu happen regularly in pigs. People do not normally get swine flu, but human infections can and do happen. Most commonly, human cases of swine flu happen in people who are around pigs but it's possible for swine flu viruses to spread from person to person also. Signs and symptoms of swine flu in people - The symptoms of swine flu in people are similar to the symptoms of regular human flu and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with swine flu. In the past, severe illness (pneumonia and respiratory failure) and deaths have been reported with swine flu infection in people. Like seasonal flu, swine flu may cause a worsening of underlying chronic medical conditions. Symptoms: Difficulty breathing or shortness of breath; Pain or pressure in the chest or abdomen; Sudden dizziness; Confusion; Severe or persistent vomiting.

93. 93Title (Schizophrenia)PsychiatryPhase 2RandomisedDouble-blindPlacebo-controlled

    A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients with Acute Schizophrenia.

94. 94Ulcerative ColitisGastroenterologyUlcerative Colitis (UC) can greatly affect your quality of life, constantly interrupting your daily activities. While there are a number of medications currently available for the treatment of UC, they are not always effective for every person, and some of these treatments may lose their effectiveness over time. Additionally, many current UC medications cause numerous unwanted side effects. For the purpose of this study, the investigational medication will be compared with placebo, a substance that looks like the investigational treatment but contains no active ingredients. However, participants will be allowed to continue taking most of their usual UC medications during the study treatment period. Study participants will also undergo a series of medical evaluations to monitor their safety and progress, including: physical exams, vital signs measurements, chest x-rays, and the collection of blood, urine, and stool samples.

    Ulcerative Colitis (UC) can greatly affect your quality of life, constantly interrupting your daily activities. While there are a number of medications currently available for the treatment of UC, they are not always effective for every person, and some of these treatments may lose their effectiveness over time. Additionally, many current UC medications cause numerous unwanted side effects. For the purpose of this study, the investigational medication will be compared with placebo, a substance that looks like the investigational treatment but contains no active ingredients. However, participants will be allowed to continue taking most of their usual UC medications during the study treatment period. Study participants will also undergo a series of medical evaluations to monitor their safety and progress, including: physical exams, vital signs measurements, chest x-rays, and the collection of blood, urine, and stool samples.

95. 95Ulcerative ColitisGastroenterologyPermitted Medications for the Treatment of UC: Patients may take the following UC treatments during study participation - Oral 5-ASA treatment and probiotics, provided that the patient was receiving the medication(s) at baseline, and that the dose(s) had been stable for 2 weeks immediately prior to enrollment. These medications should remain stable throughout the study. Oral corticosteroids that the patient is receiving at baseline, provided that the dose has been stable for the 4 weeks immediately prior to enrollment if corticosteroids have just been initiated, or the 2 weeks immediately prior to enrollment if corticosteroids are being tapered. Corticosteroid doses should remain stable until the patient meets the criteria for initiating a corticosteroid tapering regimen. Azathioprine or 6-mercaptopurine that the patient was receiving at baseline, provided that the dose has been stable for the 8 weeks immediately prior to enrollment. Dose(s) should remain stable throughout the study, unless the medication is discontinued due to a toxicity related to the medication. Even if the toxicity resolves, azathioprine or 6-mercaptopurine will not be re-started. Anti-diarrheals, as necessary for control of chronic diarrhea; stable doses are encouraged.

    Permitted Medications for the Treatment of UC: Patients may take the following UC treatments during study participation - Oral 5-ASA treatment and probiotics, provided that the patient was receiving the medication(s) at baseline, and that the dose(s) had been stable for 2 weeks immediately prior to enrollment. These medications should remain stable throughout the study. Oral corticosteroids that the patient is receiving at baseline, provided that the dose has been stable for the 4 weeks immediately prior to enrollment if corticosteroids have just been initiated, or the 2 weeks immediately prior to enrollment if corticosteroids are being tapered. Corticosteroid doses should remain stable until the patient meets the criteria for initiating a corticosteroid tapering regimen. Azathioprine or 6-mercaptopurine that the patient was receiving at baseline, provided that the dose has been stable for the 8 weeks immediately prior to enrollment. Dose(s) should remain stable throughout the study, unless the medication is discontinued due to a toxicity related to the medication. Even if the toxicity resolves, azathioprine or 6-mercaptopurine will not be re-started. Anti-diarrheals, as necessary for control of chronic diarrhea; stable doses are encouraged.

96. 96Title (Invasive Meningococcal Disease)VaccinesSafety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India: Meningococcal disease is caused by bacteria called Neisseria meningitidis (a type of germ). Meningococcal disease can occur in all age groups. Many people carry the bacteria in their nose or throat without any sign of infection. They eventually develop immunity, which protects them against future infections. However, in a small proportion of individuals, the bacteria invade the body and may cause a life-threatening infection, including meningitis (infection of the membranes covering the brain), meningococcemia (infection of the blood), infection of the joints, infection around the heart, and pneumonia. Even with proper treatment, the death rate is about 7% to 19% in patients with any type of meningococcal disease, and is as high as 18% to 53% in patients with an infection of the blood. About 20% of patients who survive meningococcal meningitis are left with serious neurological (brain or nerve) damage. Menactra® has been developed with the aim of offering longer protection against N. meningitidis serogroups A, C, Y, and W-135 among children, adolescents, and adults.

    Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India: Meningococcal disease is caused by bacteria called Neisseria meningitidis (a type of germ). Meningococcal disease can occur in all age groups. Many people carry the bacteria in their nose or throat without any sign of infection. They eventually develop immunity, which protects them against future infections. However, in a small proportion of individuals, the bacteria invade the body and may cause a life-threatening infection, including meningitis (infection of the membranes covering the brain), meningococcemia (infection of the blood), infection of the joints, infection around the heart, and pneumonia. Even with proper treatment, the death rate is about 7% to 19% in patients with any type of meningococcal disease, and is as high as 18% to 53% in patients with an infection of the blood. About 20% of patients who survive meningococcal meningitis are left with serious neurological (brain or nerve) damage. Menactra® has been developed with the aim of offering longer protection against N. meningitidis serogroups A, C, Y, and W-135 among children, adolescents, and adults.

97. 97Title (Acute Coronary Syndrome)CardiovascularPhase IIIRandomisedDouble-blind

    A Phase III, randomized, double-blind research study to determine if apixaban is superior to placebo for preventing the composite of cardiovascular death, myocardial infarction, or ischemic stroke, in subjects with a recent acute coronary syndrome (ACS).

98. 98COPD brochureRespiratoryOriginal documentA patient brochure for a once-daily COPD maintenance inhaler: why it is prescribed, how and when to take it, and important safety information.

    

99. 99Alzheimer's brochureNeurologyOriginal documentA brochure for patients and caregivers on Alzheimer's disease and a prescription medicine for it: how the disease progresses, what to expect from treatment and how to take it.

    

100. 100Title (ventricular systolic dysfunction)CardiovascularEffects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction:

     Effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction:

101. 101Depression Rating Questionnaire - Interview guide for the Montgomery and Asberg Depression Rating ScalePsychiatryThis interview guide is based on the Montgomery-Asberg Depression Rating Scale (MADRS). The scale itself has been retained in its original form, except for reversing the order of the first two items. This guide adds interview questions to aid in the assessment and application of the MADRS. Previous versions of this guide appeared in 1988, 1992, 1996, and 2005.

     This interview guide is based on the Montgomery-Asberg Depression Rating Scale (MADRS). The scale itself has been retained in its original form, except for reversing the order of the first two items. This guide adds interview questions to aid in the assessment and application of the MADRS. Previous versions of this guide appeared in 1988, 1992, 1996, and 2005.

     The SIGMA may be copied by individual researchers or clinicians for their own use without seeking permission from the publishers. The scale must be copied in full and all copies must acknowledge the following source: Williams JBW, Kobak KA. Development and reliability of a structured interview guide for the Montgomery-Asberg Depression Rating Scale (SIGMA). Br J Psychiatry 2008; 192: 52-58. Written permission must be obtained from the Royal College of Psychiatrists for copying and distribution to others or for replication (in print, online or by any other medium).

102. 102Refractive Error Quality of LifeOphthalmologyRAND hereby grants permission to use the "National Eye Institute Refractive Error Quality of Life Instrument-42 (NEI RQL-42)" in accordance with the following conditions which shall be assumed by all to have been agreed to as a consequence of accepting and using this document:

     RAND hereby grants permission to use the "National Eye Institute Refractive Error Quality of Life Instrument-42 (NEI RQL-42)" in accordance with the following conditions which shall be assumed by all to have been agreed to as a consequence of accepting and using this document:

     1. Although we do not recommend it, changes to the NEI RQL-42 may be made without the written permission of RAND. However, all such changes shall be clearly identified as having been made by the recipient.

     2. The user of this NEI RQL-42 accepts full responsibility, and agrees to hold RAND harmless, for the accuracy of any translations of the NEI RQL-42 into another language and for any errors, omissions, misinterpretations, or consequences thereof.

     3. The user of this NEI RQL-42 accepts full responsibility, and agrees to hold RAND harmless, for any consequences resulting from the use of the NEI RQL-42.

     4. The user of the NEI RQL-42 will provide a credit line when printing and distributing this document or in publications of results or analyses based on this instrument acknowledging that it was developed at RAND under the sponsorship of the National Eye Institute. The user will also cite the appropriate development papers.

103. 103Title (Retinal Vein Occlusion)OphthalmologyPhase 3RandomisedDouble-masked

     A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO): People with macular edema due to CRVO may develop leaky blood vessels in the back of the eye. This is partly caused by too much of a protein called Vascular Endothelial Growth Factor (VEGF). Fluid from these leaky blood vessels can build up and a swelling at the back of the eye (the retina) may occur. This swelling can lead to vision loss and may cause blindness. There is currently no proven treatment for the decreased vision that occurs with CRVO. The experimental drug, VEGF Trap-Eye, may block VEGF from causing fluid to leak from blood vessels in the eye. This study will test if VEGF Trap-Eye can improve vision in CRVO.

104. 104Title (Metastatic Breast Cancer)OncologyPhase 3RandomisedOpen-labelMulticentre

     A Randomized, Open-Label, Multicenter, Phase 3 Study of Epoetin Alfa plus Standard Supportive Care versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy: [withheld] Pharmaceutical Research & Development (the sponsor) are doing a research study with a drug called epoetin alfa. Two different epoetin alfa formulations are marketed by Johnson & Johnson, EPREX® (outside the U.S.) and PROCRIT® (within the U.S.). Other drugs that are similar to PROCRIT and EPREX and work the same way make up a class of drugs known as Erythropoiesis Stimulating Agents (ESA). Epoetin alfa is a form of recombinant human erythropoietin (r-HuEPO). This means that it is manufactured in the laboratory and is similar to the natural hormone. Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to increase the production of red cells in the bone marrow. Red blood cells contain hemoglobin, the red pigment inside the cell that carries oxygen to all the tissues in the body. Lack of red blood cells or hemoglobin means that you are anemic. Anemia results in many symptoms such as weakness, shortness of breath, fatigue, tiredness, and decreased activity. Regulatory agencies in approximately 90 countries around the world have approved epoetin alfa for use in patients with certain types of anemia, such as anemia associated with the treatment of cancer, kidney disease, surgery, and HIV-infected patients on certain antiviral therapy.

105. 105Pre-Surgery shower flyerPatient materialsOriginal documentA flyer for an antiseptic shower kit used before surgery: warnings, why the showers lower the risk of infection, and when to take each of the two showers.