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Drug Updates
- ACCOLATE
- Benlysta 120 mg
- Protopic 0.1% ointment
- Aminophylline injection BP 500 mg/2 ml
- Gastrocote Liquid
- Equasym XL 10 mg, 20 mg or 30 mg Capsules
- Tazocin 2g/0.25g and 4g/0.5g Powder for Solution for Injection or Infusion
- Imodium Plus Caplets GSL
- Ilaris 150mg powder for solution for injection
- Voltarol 25mg, 50mg Rapid Tablets
- E45 Itch Relief Cream
- Lescol XL 80 mg Prolonged Release Tablets
- Onbrez Breezhaler 300 microgram inhalation powder, hard capsules
- Heparin calcium 25,000 I.U./ml Solution for injection or concentrate for solution for infusion
- Kamillosan Ointment
- Hyoscine Hydrobromide 400 micrograms/ml Solution for Injection
- Abilify Tablets, Orodispersible Tablets, Oral Solution (Otsuka & Bristol-Myers Squibb)
- Anugesic HC Cream
- Arimidex 1mg Film-Coated Tablet
- Avodart 0.5mg soft capsules
- Gabapentin 100 mg Capsules
- Dovonex Ointment
- Premique Low Dose 0.3mg/1.5mg Modified Release Tablets
- Premique 0.625mg/5mg Coated Tablets
- Innohep 20,000 IU/ml and Innohep syringe 20,000 IU/ml
- NovoRapid 100 U/ml in a vial, NovoRapid Penfill 100 U/ml, NovoRapid FlexPen 100 U/ml, NovoRapid FlexTouch 100 U/ml
- Accupro Tablets 5mg, 10mg, 20mg & 40mg
- Acular
- Betaferon
- Cimzia 200 mg solution for injection
- Olanzapine 2.5mg Film-coated Tablets
- Pentasa Slow Release Tablets 1g
- COZAAR 2.5 mg/ml powder and solvent for oral suspension
- Daktarin Gold 2% Cream
- Edronax 4mg Tablets
- COZAAR 12.5 mg, 25 mg, 50 mg and 100 mg Film-Coated Tablets
- Tobi 300 mg/5 ml Nebuliser Solution
- Elocon Cream
- Famciclovir 125 mg Tablets
- Famciclovir 250mg Tablets
Acne
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Patient Preference Study Comparing Two Clindamycin / Benzoyl Peroxide Gels
Clinicalstudyresults.org (Oct 2007)
This was a multicenter study conducted by qualified investigators at 2 clinical sites in the U.S. 30 patients were planned to be enrolled at each site (total of 60 patients).
ADHD
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NICE (Jan 2008)
The advice in the NICE guideline covers: * the care, treatment and support that children, young people and adults with ADHD should be offered * how families and carers can support people with ADHD. It does not specifically look at: * the treatment of children younger than 3 years * the treatment of conditions other than ADHD.
Alzheimer’s Disease
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Clinicalstudyresults.org (Jun 1999)
The primary objectives were to: • Assess whether treatment with celecoxib 200 mg twice daily (BID) would statistically significantly limit or attenuate the progression of Alzheimer’s Disease as measured by the change in the Alzheimer’s Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) composite score and the Clinician’s Interview-Based Impression of Change Plus (CIBICPlus) score • Evaluate the safety of celecoxib at 200 mg BID in the elderly population suffering from Alzheimer’s Disease during long-term treatment The secondary objectives were to: • Evaluate the change from Baseline after one year of treatment in the Behavioral Pathology in Alzheimer’s Disease (Behave-AD) score, the Nurses Observation Scale for Geriatric Patients (NOSGER) score, the scores for the recall and recognition scales of the ADAS, the Mini-Mental State Exam (MMSE) score, and the scores of the Pharmacoeconomic (PE) and Quality of Life surveys (QOL) [SF-36] • Additional assessments included the Montgomery-Asbers Depression Rating Scale (MADRS) to confirm that depression was not playing an interfering role
Anemia
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Roche: Clinical Trials (May 2005)
This was an open, randomized, multicenter, dose escalation study investigating the effect of 3 doses of Mircera (methoxy polyethylene glycol-epoetin beta) and 3 different dosing intervals on renal anemia in patients not on dialysis.
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Clinicalstudyresults.org (May 2006)
The primary objective was to evaluate whether the efficacy of darbepoetin alfa SF is equivalent to that of darbepoetin alfa RB for the treatment of anemia in subjects with CKD who were receiving hemodialysis as measured by the mean change in hemoglobin between baseline and the evaluation period and the ratio of dosing requirements between baseline and the evaluation period.
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Study of Transplant Related Anemia Treated with Aranesp (STRATA; Study 20030139)
Centerwatch (Nov 2004)
Anemia develops in some patients with chronic kidney disease after successful renal transplantation, is often untreated, and constitutes an unrecognized medical need. In this patient population, the most common cause of anemia is graft dysfunction; however, some patients may develop anemia even if the graft is functioning normally. This nonregistrational, multicenter, prospective, single-arm study was designed to describe the effects of darbepoetin alfa on anemia recovery and health-related quality of life in subjects with anemia and renal transplant. The objective of this study was to assess the effect of darbepoetin alfa administered subcutaneously on the hemoglobin concentrations of renal transplant recipients 6 months or longer after renal transplant.
Arthritis
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Clinicalstudyresults.org (Jul 2001)
Primary objective: To compare the efficacy of celecoxib, rofecoxib, and placebo in relieving the signs and symptoms of a flare of osteoarthritis (OA) of the knee. Secondary objective: To compare the overall safety of celecoxib 200 mg once daily (QD) and rofecoxib 25 mg QD to placebo.
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Clinicalstudyresults.org (Nov 2002)
The primary objective of this study was to evaluate the efficacy and safety of celecoxib, acetaminophen, and placebo in a randomized, double-blind, crossover clinical trial in ambulatory patients with osteoarthritis (OA) of the hip or knee.
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Clinicalstudyresults.org (Oct 2000)
Protocol No. N91-99-02-047: A Multicenter, Double-Blind, Parallel Group Study Comparing the Effects on Renal Function and the Incidence of Gastroduodenal Ulcer Associated with Valdecoxib 20 mg BID and 40 mg BID with that of Naproxen 500 mg BID in Patients with Osteoarthritis or Rheumatoid Arthritis. Agrawal N, Paperiello B, Zhao WW, Kent JD, Recker DP, Verburg KM. Supratherapeutic doses of valdecoxib have a reduced incidence of gastroduodenal ulcers compared with conventional therapeutic doses of naproxen in osteoarthritis and rheumatoid arthritis patients [abstract]. Arthritis Rheum. 2001;44(suppl):S372. Abstract 1917. Agrawal N, Paperiello B, Zhao WW, Kent JD, Recker DP, Verburg KM. Supratherapeutic doses of valdecoxib have a reduced incidence of gastroduodenal ulcers compared with conventional therapeutic doses of naproxen in osteoarthritis and rheumatoid arthritis patients [abstract]. Gut. 2001;49(suppl III):1. Abstract 2157. Pfizer will use reasonable efforts to include accurate and up-to-date information on the ClinicalStudyResults.org web site. However, because the status of studies often changes, Pfizer can make no, and makes no, warranties or representations of any kind as to the currency or completeness of the information contained therein. You agree that access to and use of information posted by Pfizer on the ClinicalStudyResults.org web site is at your own risk. Pfizer disclaims all warranties, express or implied, including warranties of merchantability of fitness for a particular purpose. Pfizer shall not be liable for any damages, including without limitation, direct, incidental, consequential, indirect or punitive damages, arising out of access to, use of, or inability to use information posted by Pfizer on the ClinicalStudyResults.org web site, or any errors or omissions in the content thereof. The ClinicalStudyResults.org web site is maintained by PhRMA, a trade association of which Pfizer is a member.
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Clinicalstudyresults.org (Jun 2005)
A Multicenter, Randomized, Parallel-Group, 4-Week, Double-Blind and Active Comparator-Controlled Study to Assess the Efficacy, Safety and Tolerability of MK-0663 Tablet 60 mg Once Daily Versus Diclofenac Sodium 75 mg Two Times Daily In the Treatment of Chinese Patients with Osteoarthritis of the Knee or Hip.
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Roche: Clinical Trials (Jan 2005)
This randomized, double-blind, double-dummy, controlled, multifactorial study evaluated nine different treatment regimens in a 3 x 3 configuration, comprising three different dose levels of MabThera (rituximab) (including placebo) and three different corticosteroid regimens (including placebo), along with methotrexate (MTX), and folate. Approximately 40 RF-positive patients were enrolled into each of the nine possible combinations.
Asthma
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Clinicalstudyresults.org (May 2005)
To compare the effect of 160 ?g ciclesonide/day with 400 ?g budesonide/day on lung function, symptoms and use of rescue medication including the onset of effect in patients with bronchial asthma
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Corticosteroids for the treatment of chronic asthma in adults and children aged 12 years and over
Clinicaltrials.gov (Jan 2008)
This guidance covers the use of inhaled corticosteroids to treat adults and children aged 12 years and over with chronic asthma in the NHS in England and Wales. It is written for people with chronic asthma but it may also be useful for their families or carers or anyone with an interest in the condition.
Back Pain
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Clinicalstudyresults.org (Dec 2003)
To evaluate the efficacy and tolerability of a single dose of parecoxib 40 mg IM compared with diclofenac in the treatment of acute low back pain.
Bladder cancer
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Electrically-stimulated intravesical chemotherapy for superficial bladder cancer
Clinicaltrials.gov (Jan 2008)
This procedure, also known as electromotive drug administration (EMDA) of intravesical chemotherapy, can be used for patients with bladder cancer, either before or after surgery. A solution including a chemotherapy drug is injected into the bladder using a thin tube inserted through the urethra. At the same time, an electrode is inserted in the bladder and other electrodes are placed on the skin of the lower abdomen. An electric current is then created with the aim of improving absorption of the chemotherapeutic drugs.
Bone Cancer
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Experimental Drug for Osteosarcoma Improves Overall Survival
National Cancer Institute (Feb 2008)
The study - conducted by the Children's Oncology Group - was the largest final-stage randomized trial in this disease and included 662 patients with newly diagnosed nonmetastatic osteosarcoma.
Brain cancer
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Palliative Radiation Extends Survival for Elderly Patients with Glioblastoma
National Cancer Institute (Mar 2007)
The investigators enrolled 81 patients 70 years of age or older with glioblastoma into the trial. All patients had good functional status. Forty-two received supportive care alone, including antiseizure medication, physical and psychological support, and access to a palliative care team. The other 39 patients received supportive care and radiation therapy (50 Gy in doses of 1.8 Gy per day, given 5 days a week).
Breast Cancer
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Roche: Clinical Trials (Jan 2007)
This was a prospective, randomized, open label, multicenter trial to compare therapy with taxotere + epirubicin with or without Xeloda (capecitabine) in patients with metastatic or locally advanced breast cancer
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Clinicalstudyresults.org (Feb 2005)
The study was designed to analyze 40 fully evaluable patients (including clinical evaluability, pharmacokinetic, tumor and skin samples evaluability). The non-evaluability rate was initially estimated to be 20%. A maximum of 50 patients were to be recruited in order to obtain 40 fully evaluable patients. In June 2004, on the basis of the actual non-evaluability rate (41%), the maximum number of recruited patients was increased to 65 in order to obtain 40 fully evaluable patients. The sponsor decided to stop the patient recruitment on 30 December 2004. A total of 59 patients were actually enrolled in the study.
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Roche: Clinical Trials (Jan 2006)
This study was set up as a three-arm, randomized, open-label, multi-center study in women with primary breast cancer that overexpress HER2, comparing the effect of 1 year or 2 years of Herceptin treatment and standard adjuvant treatment without Herceptin.
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Age, Type of Chemotherapy Affect Women's Chances of Menstruating after Breast Cancer Treatment
National Cancer Institute (Mar 2006)
This observational study found that premenopausal breast cancer patients were more likely to return to their normal menstrual cycles after chemotherapy-induced amenorrhea if they were younger than 35 and if their chemotherapy had been an anthracycline-based regimen. The breast cancer hormone treatment tamoxifen also disrupted some women’s menstruation, but the modest effect disappeared after three years.
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Clinicalstudyresults.org (Feb 2006)
The primary objective of this study was to evaluate the safety and efficacy of anastrozole (daily 1 mg dose) for the treatment of McCune-Albright Syndrome (MAS) in girls up to the age of 10 years, receiving treatment for 1 year. The tolerability and safety of study treatment was assessed by assessment of adverse events, withdrawals and laboratory data. The efficacy of study treatment was assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity. Secondary objectives included assessments of pubertal progression through Tanner Staging and mean ovarian and uterine volume as assessed by ultrasound, bone growth by assessment of predicted adult height for children aged over 6 years and pharmacokinetic assessment.
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Anastrozole, Tamoxifen, and Bone Loss on the ATAC Trial
National Cancer Institute (Mar 2008)
Postmenopausal women taking the drug anastrozole (Arimidex®) to prevent a recurrence of breast cancer suffered more bone loss than women taking tamoxifen (Nolvadex®), even while anastrozole provided better protection against relapse, according to a substudy of a major clinical trial comparing the two drugs. Doctors and patients need to consider all risks and benefits when deciding on the best adjuvant approach for women with hormone-positive, early-stage breast cancer.
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Bevacizumab for the first-line treatment of metastatic breast cancer
Clinicaltrials.gov (Jan 2008)
NICE is unable to recommend the use in the NHS of bevacizumab in combination with paclitaxel for the first-line treatment of metastatic breast cancer because no evidence submission was received from the manufacturer or sponsor of the technology
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Boost Radiation Beneficial in Early-Stage Breast Cancer
National Cancer Institute (Aug 2007)
In women with early-stage breast cancer who had been treated with breast-conserving lumpectomy and radiation, an additional “boost” dose of radiation to the original tumor site reduced the risk of cancer coming back in the same breast, though it did not help them live longer.
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Roche: Clinical Trials (Nov 2002)
This was an expanded access, Phase IV, open-label, non-randomized, multi-center study of patients with metastatic breast cancer with tumors that overexpress HER2, who were not eligible for other Herceptin studies. Patients received weekly intravenous (iv) Herceptin 2 mg/kg for a minimum of 8 weeks and until disease progression, in combination with either paclitaxel 100 mg/m2 or docetaxel 175 mg/m2 3 times weekly for 18 weeks.
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NICE (Jan 2007)
Gemcitabine, which is combined with another medicine called paclitaxel to treat metastatic breast cancer, is only recommended as a possible treatment for people with metastatic breast cancer in situations where two other treatments could also be used as alternatives. Other treatments that doctors could use in the same situation are a medicine called docetaxel (given on its own) and docetaxel combined with another medicine called capecitabine.
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Heart Problems From Trastuzumab (Herceptin®) Do Not Increase in the Short Term
National Cancer Institute (Jun 2007)
It’s known that women with HER2-positive breast cancer who take the drug trastuzumab (Herceptin®) in addition to chemotherapy are at greater risk of heart problems during treatment. Now a study has shown that the incidence of such problems does not increase in the short term and that many women regain heart health after an initial decline. However, the long-term effects of trastuzumab on the heart remain to be determined.
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Paclitaxel Versus Docetaxel for Early Breast Cancer
National Cancer Institute (Mar 2008)
In a study comparing different dosing schedules of two common breast cancer drugs, weekly treatment with the drug paclitaxel (Taxol) in addition to standard chemotherapy proved most effective in extending overall survival and disease-free survival among women with early-stage breast cancer. Treatment with the drug docetaxel (Taxotere) every three weeks improved patients’ disease-free survival and is also an acceptable choice.
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Clinicalstudyresults.org (Nov 2004)
A multicenter study to provide data on the safety and efficacy of pegfilgrastim administered on the same day as chemotherapy versus next day, as measured by the duration of grade 4 neutropenia
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Study Confirms Risk of Bone Loss for Patients Taking Exemestane
National Cancer Institute (Jan 2007)
Women who switched to the drug exemestane (Aromasin®) after taking tamoxifen (Nolvadex®) to prevent a breast cancer relapse lost more bone density and had a higher risk of bone fractures than women who continued taking tamoxifen, an international study has concluded.
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Taxane Combinations Marginally Better than Anthracyclines for Metastatic Breast Cancer
National Cancer Institute (Mar 2008)
Combined data from eleven clinical trials showed that patients receiving taxanes (paclitaxel or docetaxel) for the treatment of newly diagnosed advanced breast cancer lived about as long as those receiving anthracyclines (epirubicin or doxorubicin). As single-agents, however, the anthracyclines offered better progression-free survival. Combinations based on taxanes provided better response rates and also better progression-free survival than those based on anthracyclines.
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Whole Brain Radiation May be Postponed in Cancer Patients with Limited Metastasis to the Brain
National Cancer Institute (Jun 2006)
Patients who received stereotactic radiosurgery for four or fewer contained metastases to the brain lived as long, and had comparable radiation side effects and mental functioning, as patients who were also treated with whole brain radiation. However, the radiosurgery-only patients had higher recurrence in their brain and were more likely to require salvage treatment.
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Zoledronic Acid Improves Early Breast Cancer Treatment
National Cancer Institute (Jun 2008)
The addition of zoledronic acid (Zometa) to adjuvant endocrine therapy in premenopausal women with early stage breast cancer significantly improves clinical outcomes beyond those achieved with endocrine therapy alone, researchers reported at the ASCO annual meeting.
Cervical Cancer
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Clinicalstudyresults.org (Feb 2007)
The objectives of the study were the evaluation of the efficacy and safety of a neoadjuvant treatment with irinotecan HCL and cisplatin (CDDP) in subjects with locally advanced cervical cancer. The primary endpoint was response rate. Secondary endpoints were the rate of complete pathological response, progression free survival, overall survival, and clinical safety including surgical morbidity and laboratory determinations.
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Cisplatin Plus Topotecan Gives Patients with Advanced Cervical Cancer More Time
National Cancer Institute (Jun 2005)
Women with advanced or recurrent cervical cancer who were treated with a combination of cisplatin (Platinol®) and topotecan (Hycamtin®) lived a few months longer, and went longer without their disease progressing, than patients who received cisplatin alone. The additional toxicity did not significantly affect their quality of life compared to the cisplatin-only patients.
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Incomplete Excision a Risk for Those With Precancerous Cervical Intraepithelial Neoplasia (CIN)
National Cancer Institute (Nov 2007)
Surgery to remove abnormal cells on the cervix can prevent a precancerous condition known as cervical intraepithelial neoplasia (CIN) from progressing to cervical cancer. In some cases, however, abnormal cells are not completely removed, leaving an “involved margin.” A combined analysis of previous studies has shown that after surgery for CIN, women with involved margins have a substantially higher risk of the disease coming back than women whose margins were clear of abnormal cells.
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Long-Term Data Support Cisplatin-Based Chemoradiation for Cervical Cancer
National Cancer Institute (Jun 2007)
Women with cervical cancer that had spread locally or regionally who received the chemotherapy drug cisplatin in addition to radiation therapy lived significantly longer than women who received the drug hydroxyurea in addition to radiation therapy.
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Vaccine Against Cervical Cancer Virus is Effective for More than Four Years
National Cancer Institute (Apr 2006)
An experimental vaccine that protects against two types of a virus that can cause cervical cancer remained highly effective for up to 4.5 years and caused very few adverse effects, an international team of researchers reports.
Chronic Kidney disease
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NICE (Jan 2008)
The advice in the NICE guideline covers: * the tests doctors should use to diagnose long-term kidney problems (chronic kidney disease) * the best treatment and care for adults diagnosed with chronic kidney disease, and when they should be referred to specialist renal services * the general management of chronic kidney disease from a variety of causes including diabetes, high blood pressure and cardiovascular disease.
CML
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Registration of Children With CML and Treatment With Imatinib (CML-paed II)
Clinicaltrials.gov (Jan 2012)
Newly diagnosed pediatric patients (age < 19 years) with bcr-abl-positive CML will be treated with imatinib. Serial monitoring of treatment response is performed in one month intervals during the first three months of treatment and in three months intervals thereafter. Patients with non-response, poor response (either molecular, cytogenetic, or hematologic non-/poor response) or progress of the disease while under imatinib treatment will stop imatinib and undergo stem cell transplantation. All responders to imatinib treatment with an HLA matched donor will undergo stem cell transplantation not later than 2 years after diagnosis.
Colon Cancer
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Palifermin Reduces Chemo-Induced Mouth Sores in Colorectal Cancer Patients
National Cancer Institute (Nov 2006)
The drug palifermin reduced the frequency and severity of mouth sores caused by the chemotherapy drug fluorouracil in patients with advanced colorectal cancer. Patients who took palifermin were more likely than those taking a placebo to receive their full dose of chemotherapy.
Colorectal Cancer
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Roche: Clinical Trials (Jan 2008)
This was an open-label, multicenter, non-comparative, national phase II clinical trial to assess the safety and efficacy profiles of intermittent therapy with Xeloda (capecitabine) as first-line chemotherapy in patients with colorectal cancer metastases followed by a second line treatment option with Xeloda + oxaliplatin combination therapy
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Bevacizumab and cetuximab for the treatment of metastatic colorectal cancer
NICE (Jan 2007)
Bevacizumab in combination with 5-fluorouracil plus folinic acid, with or without irinotecan, is not recommended for people with metastatic colorectal cancer who have not been treated before. Cetuximab in combination with irinotecan is not recommended for people with metastatic colorectal cancer who have had previous treatment for the cancer that also included irinotecan. Consultants should not stop prescribing bevacizumab or cetuximab for people who were already taking it when the guidance was issued. These patients should be able to carry on taking bevacizumab or cetuximab until they and their consultants decide that it is the right time to stop treatment
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Chemotherapy Delays Recurrence of Liver Metastases from Colorectal Cancer
National Cancer Institute (Jan 2006)
In patients with colorectal cancer that had spread to the liver, recurrence of disease was delayed longer in those who received chemotherapy in addition to surgery than in those who had surgery alone, a new study has found. However, the study did not definitively show that adding chemotherapy to surgery lengthened patients’ lives overall.
Congestive Heart Failure
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Centerwatch (Jan 2008)
This randomized, double-blind study evaluated the use of plasma NT-proBNP measurements to improve the diagnostic accuracy of congestive heart failure and the predication of clinical outcomes in patients who present to emergency departments with acute dyspnea.
Diabetes
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Continuous subcutaneous insulin infusion for the treatment of diabetes (review)
Clinicaltrials.gov (Jan 2008)
This guidance replaces NICE technology appraisal guidance 57 issued in February 2003. The review and re-appraisal of the use of continuous subcutaneous insulin infusion for the treatment of diabetes mellitus has resulted in a change in the guidance. Specifically there has been a change to the recommendation on the use of continuous subcutaneous insulin infusion in children younger than 12 years with type 1 diabetes mellitus.
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Clinicaltrials.gov (Jan 2008)
This guidance covers the care and treatment of pregnant women with diabetes in the NHS in England and Wales. It also covers the care of their newborn babies. It is written for women who have diabetes or develop it in pregnancy, but it may also be useful for their families or for anyone with an interest in the condition. July 2008: Since publication, the information on the therapeutic indications, contraindications and use in pregnancy and lactation of drugs used in diabetes management and retinal assessment (specifically insulins, the oral hypoglycaemic agents metformin and glibenclamide, and tropicamide) has been corrected to follow the relevant summaries of product characteristics (SPCs) (July 2008). Changes have been made to the NICE guideline, the full guideline and the quick reference guide. 'The recommendation on the use of the rapid-acting insulin analogues aspart and lispro in pregnant women with diabetes (this is recommendation 1.1.6.2 in the NICE guideline) is now as follows: Healthcare professionals should be aware that data from clinical trials and other sources do not suggest that the rapid-acting insulin analogues (aspart and lispro) adversely affect the pregnancy or the health of the fetus or newborn baby
Diabetes Type 1
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Clinicalstudyresults.org (Dec 2004)
Primary Objective: The primary objective of the present study was to investigate the short- and long-term effect of quinapril on wall thickness and distensibility of 2 large arteries (common carotid artery and abdominal aorta) and 1 medium sized artery (radial artery). The measurement of wall thickness and distensibility of a third large artery (i.e., the femoral artery) was planned in the original protocol but was not performed. Secondary Objectives: The secondary objectives of the study were: • To investigate the correlation between modification of structure and function by treatment and concomitant changes in clinic blood pressure, 24-hour ambulatory blood pressure, albumin excretion rate (AER), glucose and lipid profile • To evaluate the safety and tolerability of quinapril
Diabetes Type 2
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Clinicalstudyresults.org (Jun 2001)
An increase in fluid-related adverse events (AEs), including edema and congestive heart failure (CHF) was observed in subjects receiving 8mg/day RSG with fixed doses of background insulin compared to insulin therapy alone. In this study, the RSG dose was to be slowly increased and the insulin dose decreased whilst still maintaining glycaemic control in subjects with type 2 diabetes mellitus who had no prior history of CHF (New York Class I to IV inclusive)
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Clinicalstudyresults.org (Jan 2004)
Primary Objectives: To examine the effect of exenatide subcutaneous (SC) injection for 28 days on glucose control as measured by glycosylated hemoglobin specific A1c fraction (HbA1c) in subjects with type 2 diabetes mellitus, and to assess the safety and tolerability of exenatide SC injection for 28 days in subjects with type 2 diabetes mellitus. Secondary Objectives: To examine the effect of exenatide SC injection for 28 days in subjects with type 2 diabetes mellitus on serum fructosamine concentration, body weight, postprandial blood glucose concentrations, and fasting plasma glucose concentrations.
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Clinicalstudyresults.org (Sep 2005)
Primary Objectives were to assess the effects of subcutaneously injected exenatide administered two times a day in subjects with type 2 diabetes treated with metformin, a sulfonylurea, or metformin/sulfonylurea combination on 1) glycemic control as measured by HbA1c, and 2) long term safety. Secondary Objectives were to examine the long-term effects of subcutaneously injected exenatide administered BID in subjects with type 2 diabetes treated with metformin, a sulfonylurea, or metformin/sulfonylurea combination on fasting concentrations of plasma glucose, fasting concentrations of lipids, body weight, and appearance of anti-exenatide antibodies.
Drug Interaction Study
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Clinicalstudyresults.org (Oct 2005)
Primary: To estimate the effect of efavirenz on the pharmacokinetics of voriconazole at steady-state and to estimate the effect of voriconazole on the pharmacokinetics of efavirenz at steady-state Secondary: To estimate the effect of efavirenz administration on the pharmacokinetics of voriconazole N-oxide metabolite at steady-state and to evaluate the safety and tolerability of voriconazole and efavirenz administered alone or in combination
Eczema
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Clinicalstudyresults.org (Mar 2006)
The primary objective of this study was to assess the safety of long-term use of cetirizine dry syrup (CTZ) in children (? 2 years of age or older but < 15 years old) with various type of cutaneous disease accompanied with pruritus. Subjects included in the study were considered to require long term therapy of 12 weeks.
Epilepsy
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Clinicalstudyresults.org (Feb 2004)
Women with epilepsy are more likely to experience polycystic ovary syndrome (PCOS) than are women in the general population. PCOS is a reproductive endocrine disorder characterized by signs and symptoms of androgen excess and associated with metabolic and cardiovascular abnormalities. However, there is little prospective data regarding PCOS in women taking antiepileptic drugs (AEDs). This study was designed to address the paucity of prospective data about the prevalence and development of components of PCOS in women with epilepsy starting treatment with lamotrigine (LTG) or valproate (VPA).
Esophageal Cancer
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Patients With Esophageal Cancer May Be Able to Avoid Surgery
National Cancer Institute (Apr 2007)
In this randomized clinical trial, patients with esophageal cancer lived just as long after receiving chemoradiation therapy alone as did those whose chemoradiation therapy was followed by surgery.
Fungal infection
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Clinicalstudyresults.org (Jun 2003)
The study objective was to determine the efficacy and safety of intravenous micafungin (FK463) versus placebo as prophylactic therapy for invasive fungal infections in patients in the ICU who were considered to be at high risk for invasive fungal infection.
GERD
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Clinicalstudyresults.org (Apr 2007)
The primary objective of this study was to compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg (E40), lansoprazole 30 mg (L30) and pantoprazole 40 mg (P40) taken orally, once daily (qd) in Hispanic patients with symptomatic gastroesophageal reflux disease (GERD). The secondary objectives of this study were: 1. To compare nocturnal intragastric acid control in Hispanic patients with symptomatic GERD taking E40, L30, or P40 qd 2. To compare integrated gastric acidity (IGA) during the 24-hour monitoring period on Day 5 among Hispanic patients with symptomatic GERD taking E40, L30, or P40 qd 3. To assess the short-term safety and tolerability of E40, L30, and P40 qd in Hispanic patients with symptomatic GERD
Gout
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Clinicalstudyresults.org (May 2005)
This was a double-blind, parallel-group, multicenter, randomized, activecomparator- controlled, 5-day study. Patients with acute gout was randomly assigned to receive ETORICOXIB 120 mg once daily (N=90) or indomethacin 75 mg 2 times daily (N=90) for 5 days. The primary efficacy endpoint is: Patient assessment of pain. The secondary efficacy endpoints are: Patient Global Assessment of Response to Therapy; Investigator Global Assessment of Response to Therapy; Tenderness of the study joint; Swelling of the study joint and Proportion of patients discontinuation due to lack of efficacy.
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Febuxostat for the management of hyperuricaemia in people with gout
Clinicaltrials.gov (Jan 2008)
Febuxostat is recommended as a possible treatment for chronic hyperuricaemia in people with gout only if: * they can't take the medicine allopurinol for medical reasons or * the side effects of allopurinol are so bad that the person either has to stop taking it or can't be given the most effective dose. People who were already taking febuxostat when the guidance was issued should be able to carry on taking it until they and their healthcare professional(s) decide that it is the right time to stop treatment.
Head and Neck Cancer
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Cetuximab (Erbitux®) Plus Chemo Extends Survival in Advanced Head and Neck Cancer
National Cancer Institute (Sep 2008)
Patients with recurrent or metastatic squamous cell carcinoma of the head and neck who received cetuximab (Erbitux®) in addition to standard chemotherapy lived about three months longer than those receiving chemotherapy alone.
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Chemotherapy During Radiation Treatment Improves Outcomes in Nasopharyngeal Cancer
National Cancer Institute (Jan 2006)
Researchers analyzed data from a number of international clinical trials and found that adding chemotherapy to the standard radiation treatment for nasopharyngeal cancer reduced the risk of death, and also of cancer recurrence. The modest but real benefit was evident primarily when the chemotherapy was given during the course of radiation therapy, rather than before or after.
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Frozen Glove Reduces Skin and Nail Damage from Docetaxel Chemotherapy
National Cancer Institute (Jul 2005)
Patients who wore an experimental “frozen glove” to keep their hands very cold during intravenous chemotherapy with docetaxel (Taxotere®) had much less subsequent damage to the nails and skin of their hands, according to a French study.
Heart Failure
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Clinicalstudyresults.org (Mar 2004)
To evaluate the efficacy of varying doses of YM087 in patients who have decompensated chronic heart failure as measured by the change in (1) Patient and Clinician Global Assessments; (2) Visual Analog Scale (VAS) scores for global and respiratory status; (3) Patient and Clinician Dyspnea Assessments; (4) respiratory rate (RR); (5) fluid balance; (6) clinical signs of heart failure; (7) body weight; (8) the duration of the index hospitalization (from the time of randomization); and (9) vital status (morbidity and mortality).
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Roche: Clinical Trials (Mar 2006)
This is an open-label, prospective study of the tolerability of Dilatrend in elderly patients. Patients were recruited primarily from private cardiology practices. Dilatrend was uptitrated to ≥6.25 mg twice daily. The investigator performed assessments at Time 0 (prior to commencement of Dilatrend) and after 6 months of Dilatrend therapy.
Hepatitis B
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Clinicalstudyresults.org (Dec 2002)
Primary: The primary objectives of this study were to compare the effect of eplerenone plus standard therapy versus placebo plus standard therapy on (1) the rate of all cause mortality and (2) the rate of cardiovascular (CV) mortality/CV hospitalization. CV hospitalization was defined as hospitalization for heart failure [HF], recurrent acute myocardial infarction [AMI], stroke, or ventricular arrhythmia, while CV mortality/CV morbidity was defined as the time to first occurrence of either CV death or CV hospitalization, in patients with HF after AMI. All cause mortality was defined as any mortality adjudicated as follows: CV mortality (defined as sudden cardiac death, recurrent AMI, HF, stroke or other CV mortality, including aneurysm or pulmonary embolism); non-CV mortality (including sepsis, pneumonia, cancer, and other non- CV mortality); unwitnessed death or unknown reason for death. Secondary: The secondary objectives of this study were to compare the 2 treatment groups for the following: time to CV mortality (as previously described); all cause mortality/hospitalization; and CV mortality/nonfatal AMI. All cause hospitalization was defined as: CV hospitalizations; hospitalizations for other CV reasons (defined as: atrial flutter, atrial fibrillation, supraventricular tachycardia; angina [stable or unstable]; other CV hospitalizations, including peripheral vascular disease, hypotension, elective CV surgery, or other CV procedures; non-CV hospitalizations [defined as: pneumonia;
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Clinicalstudyresults.org (May 2004)
The hypothesis of this study is that adding entecavir 1.0 mg to lamivudine will be superior to adding placebo to lamivudine in reducing HBV DNA levels from baseline in HIV/HBV co-infected subjects who had experienced recurrence of HBV viremia on a lamivudine-containing HAART regimen.
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Clinicalstudyresults.org (Feb 2007)
This open-label extension study was performed as a statistically significant difference favoring eplerenone over placebo for both of the primary endpoints was reported in Eplerenone Post-Acute Myocardial Infarction (AMI) Heart Failure Efficacy and Survival Study (EPHESUS). The objective of this open-label extension study was to provide eplerenone to subjects who did not permanently discontinue study medication during the EPHESUS Study or EPHESUS Double-Blind Extension. All subjects in the open-label extension study were to receive eplerenone until the drug was commercially available for the heart failure indication in the respective country, but no longer than 30 months (36 months for selected sites in Israel) after the first visit of the open-label extension study or until other plans were made by the sponsor to supply drug.
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Entecavir for the treatment of chronic hepatitis B
Clinicaltrials.gov (Jan 2008)
Entecavir is recommended as a possible treatment for people with chronic hepatitis B.
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Telbivudine for the treatment of chronic hepatitis B
NICE (Jan 2008)
Telbivudine is not recommended for people with chronic hepatitis B. Healthcare professionals should not stop prescribing telbivudine for people who were already taking it when the guidance was issued.These patients should be able to carry on taking telbivudine until they and their healthcareprofessionals decide that it is the right time to stop treatment.
Hepatitis B, Chronic
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Prevention of Recurrent Hepatitis B After Liver Transplantation
Roche: Clinical Trials (Feb 2008)
This was a non-randomized, open-label, single arm study to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.
Hepatitis C
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A Study of Roferon-A (Interferon Alfa-2a) in Patients With Chronic Hepatitis C
Centerwatch (Jan 2009)
This study will evaluate the safety and tolerability of interferon alfa-2a in combination with ribavirin in patients with chronic hepatitis C. Patients who have never received prior interferon therapy, and patients who have relapsed after prior interferon therapy, will be eligible for this trial. the anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. Target sample size is 5000.
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Clinicalstudyresults.org (Dec 1995)
Chronic hepatitis C is a significant cause of morbidity and mortality in man. An effective, well tolerated treatment for this disease is highly desirable. The absence of reliable in vitro and in vivo models to predict the activity of lamivudine against the hepatitis C virus justifies this study in man. Lamivudine has been studied in subjects with HIV and chronic hepatitis B infection, and has shown significant activity. These results do not preclude a small pilot study in subjects with chronic hepatitis C infection.
HIV
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Clinicalstudyresults.org (Jun 2006)
Study M03-613 was a Phase 2, randomized, open-label, multicenter study in ARV-naïve, HIV-infected adults designed to assess the safety, tolerability, antiviral activity, and metabolic effects of a protease inhibitor (PI) induction/maintenance regimen and an RTI only regimen. The planned duration of this study was at least 96 weeks.
HIV Infections
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Roche: Clinical Trials (Mar 2007)
This was a prospective, multicenter, single-arm, open-label, 24-week study to assess the efficacy and safety of treatment with darunavir/ritonavir + Fuzeon + a background antiretroviral regimen in Fuzeon-naive HIV-1 infected patients.
Hodgkin Lymphoma
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Lower-Toxicity Treatment Effective in Some Cases of Early-Stage Hodgkin's Lymphoma
National Cancer Institute (Jul 2006)
An experimental low-intensity four-drug chemotherapy regimen plus limited radiation therapy improved cancer-free survival in patients with early-stage Hodgkin’s lymphoma who had a favorable outlook. However, patients with an unfavorable outlook did better with standard six-drug chemotherapy plus limited radiation therapy.
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PET Can Strongly Predict Likelihood of Early Relapse in Hodgkin Lymphoma
National Cancer Institute (Aug 2007)
positron emission tomography (PET) scan taken after two cycles of standard chemotherapy in patients with advanced Hodgkin lymphoma was able to predict with 92-percent accuracy how effective a complete course of the chemotherapy would be. The PET scan was able to distinguish between patients who would achieve long-term control of their disease and patients whose disease would progress during treatment or immediately thereafter or would later relapse. This procedure can be used to identify Hodgkin lymphoma patients who might benefit from a switch to more-intensive chemotherapy.
Hypertension
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Clinicalstudyresults.org (Jan 2006)
The primary objective of this study was to determine if trandolapril/verapamil SR (Tarka®) was superior to amlodipine/benazepril (Lotrel®) in the reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy. Albuminuria was to be determined as the urine albumin:creatinine ratio (UACR). The secondary objectives of this study were: 1. To compare the effects of Tarka and Lotrel on changes in blood pressure (BP) and BP control, proteinuria, estimated glomerular filtration rate (GFR). 2. To compare antihypertensive drug use in each treatment group by drug, dose, and class. 3. To compare the safety profile of Tarka and Lotrel by evaluating lipid parameters, glycemic control, quality of life using the 36-Item Short Form Health Survey (SF-36), and adverse events. 4. From a substudy, to explore the effects of Tarka and Lotrel on serum high-sensitivity C-reactive protein (hsCRP), urinary malondialdehyde (MDA) and carbonylated proteins as oxidative stress markers, urinary monocyte chemotactic protein-1 (MCP-1) as an inflammatory marker, transforming growth factor-? (TGF- ?) as a profibrotic marker, proteinuria selectivity index, and ambulatory blood pressure parameters.
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Clinicalstudyresults.org (Feb 2000)
To assess the difference in antihypertensive efficacy between the treatment regimens (candesartan cilexetil and losartan) at Double-blind Week 8.
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Roche: Clinical Trials (Feb 2005)
This was an open-label, parallel group, controlled study of the efficacy, safety, and dose-response of cilazapril (Inhibace) compared with atenolol in the treatment of patients with arterial hypertension on diuretic therapy in the presence of concomitant atherosclerosis risk factors. Patients were randomized to Group A, atenolol 50 mg/day, or Group B, Inhibace 2.5 mg/day, and were treated for 6 weeks.
Influenza
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Clinicalstudyresults.org (Aug 2006)
Multicentre, open, controlled, randomised study (1:1) with 2 groups, each subdivided into two age groups of subjects aged 18-60 years, and subjects aged >60 years. Data from the groups receiving the currently registered vaccine are presented. Data from the investigational vaccine, which is not yet approved or marketed, are not reported at this time.
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Clinicalstudyresults.org (Jul 2006)
Previous attempts to develop an oral formulation of zanamivir were limited by poor bioavailability. One strategy to overcome this issue is to combine zanamivir with paracellular permeability enhancing excipients in order to improve its absorption. In this study, the Intelisite technology was used to deliver zanamivir to the mucosa of the small intestine, with the bioenhancing excipients in close proximity. This method of delivery was expected to provide the optimal conditions to maximize the effect of the excipients (i.e. limited dilution in gastric fluids). The purpose of this study was to evaluate the relative bioavailability of four oral formulations of zanamivir coadministered with bioenhancing excipients delivered to the proximal jejunum compared to the bioavailability of of unenhanced zanamivir delivered to the proximal jejunem. In the event that the reference treatment resulted in inadequate serum zanamivir concentrations, an oral aqueous solution of zanamivir was to be evaluated as an alternate reference treatment. If significant improvement in bioavailability was observed with these novel formulations, an enteric coated, bioenhanced, oral zanamivir formulation could be pursued further.
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An Open-Label, Multi-center Study of the Patient Instructional Leaflet for RELENZA DISKHALER.
Clinicalstudyresults.org (Mar 2000)
Zanamivir (ZAN) for inhalation is delivered directly to the respiratory tract via the dry powder inhaler system, the Diskhaler. The Patient Instructional Leaflet (PIL), for use of the Diskhaler, containing color pictures and detailed instructions, was developed through an intensive process of testing in numerous consumer groups.
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An Open-Label, Multi-center Study of the Patient Instructional Leaflet for RELENZA DISKHALER.
Clinicalstudyresults.org (Mar 2000)
Primary Objective To evaluate subject assembly and use of the Diskhaler using the ZAN PIL in subjects with influenza-like illness.
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Roche: Clinical Trials (Jan 2008)
This was an open-label study to collect safety data on the use of Tamiflu for 6 weeks for the prevention of influenza in children during the influenza season.
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Centerwatch (Jan 2008)
This was an open-label study to collect safety data on the use of Tamiflu for 6 weeks for the prevention of influenza in children during the influenza season.
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clinicaltrials.gov (Jan 2007)
This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.
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Oseltamivir, amantadine and zanamivir for the prophylaxis of influenza (including a review of TA67)
NICE (Jan 2008)
NICE has said that its recommendations about oseltamivir and zanamivir should not reduce efforts to give vaccination (also called the flu jab) to people for whom it is recommended in national guidelines. The guidance does not cover widespread epidemics. Oseltamivir and zanamivir are recommended to prevent flu if all of the following apply: * The amount of flu virus going around is enough that if someone has a flu-like illness it is likely that it has been caused by the flu virus * The person is in an at-risk group (see page 4). * The person has been in contact with someone with a flu-like illness and can start treatment within 36 hours (for zanamivir) or within 48 hours (for oseltamivir) * The person has not been effectively protected by vaccination
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Clinicaltrials.gov (Jan 2008)
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Sub
Irritable bowel symdrome
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Clinicaltrials.gov (Jan 2008)
"The advice in the NICE guideline covers the care of adults with irritable bowel syndrome, including: *the support, treatment and advice people should be offered by their GP in diagnosing and helping to manage their irritable bowel syndrome *circumstances when people need to be referred to a specialist for further tests. It does not specifically look at: *irritable bowel syndrome in children and young people under 18 years *people with other gastrointestinal disorders such as non-ulcer dyspepsia (indigestion with no obvious cause) or coeliac disease. "
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Clinicaltrials.gov (Jan 2008)
The advice in the NICE guideline covers the care of adults with irritable bowel syndrome, including: * the support, treatment and advice people should be offered by their GP in diagnosing and helping to manage their irritable bowel syndrome * circumstances when people need to be referred to a specialist for further tests. It does not specifically look at: * irritable bowel syndrome in children and young people under 18 years * people with other gastrointestinal disorders such as non-ulcer dyspepsia (indigestion with no obvious cause) or coeliac disease.
Kidney Cancer
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Sorafenib Increases the Risk of High Blood Pressure
National Cancer Institute (Jan 2008)
Combined data from nine studies showed that patients receiving the standard amount of sorafenib (Nexavar), an anticancer drug that interferes with a tumor’s blood supply, run a significant risk of high blood pressure (hypertension). Doctors should closely monitor these patients during treatment and prescribe anti-hypertension drugs as needed.
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Sunitinib and Temsirolimus: Two New Targeted Drugs for Advanced Kidney Cancer
National Cancer Institute (Jun 2006)
In separate clinical trials, two new targeted drugs - sunitinib (Sutent®) and temsirolimus - have shown positive results in patients with advanced kidney cancer, offering new standards of care.
Kidney Disease
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Clinicalstudyresults.org (May 2006)
The primary objective was to evaluate whether the efficacy of darbepoetin alfa SF is equivalent to that of darbepoetin alfa RB for the treatment of anemia in subjects with CKD who were receiving hemodialysis as measured by the mean change in hemoglobin between baseline and the evaluation period and the ratio of dosing requirements between baseline and the evaluation period.
Kidney Transplantation
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Centerwatch (Apr 2007)
This was a prospective, open label, multicenter study to determine whether pediatric renal transplant patients were able to mount a primary immune response, while treated with Zenapax. The study was not fully recruited, and only a small number of patients contributed to the analysis.
Leukemia
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Clinicalstudyresults.org (Jul 2005)
The primary objective of this study was to compare the major cytogenetic response (MCyR) rates of dasatinib after a minimum follow-up of 6 months when administered once daily (quaque die, QD) relative to dasatinib administered twice daily (bis in die, BID) in the treatment of subjects with chronic phase chronic myelogenous leukemia (CP CML) resistant to imatinib.
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Clinicaltrials.gov (Jan 2017)
Nordic Society of Paediatric Haematology and Oncology (NOPHO) Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults With Acute Lymphoblastic Leukemia. Efficacy of Individualised 6MP Dosing During Consolidation Therapy.
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Allogeneic (Donor) Stem-Cell Transplant Boosts Survival in Ph-Negative, Standard-Risk ALL
National Cancer Institute (Nov 2007)
In the largest-ever clinical trial of treatment for adults with acute lymphoblastic leukemia (ALL), patients with standard-risk, Philadelphia-chromosome-negative ALL lived significantly longer after chemotherapy-induced first remission when they received allogeneic (donor) stem-cell transplantation instead of continued chemotherapy. Surprisingly, high-risk Ph-negative patients benefited less from having a stem-cell donor than the standard-risk patients. Autologous (self) stem-cell transplantation was less effective than continued chemotherapy for those patients without a stem-cell donor.
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Low-Dose Cytarabine Improves Survival of Older Patients with Leukemia
National Cancer Institute (Mar 2007)
Low doses of the chemotherapy drug cytarabine increased overall survival compared with the drug hydroxyurea in patients with acute myeloid leukemia who were not healthy enough to receive the standard treatment of high-dose, intensive chemotherapy.
Liver Cancer
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Single-Agent Pemetrexed in Patients with Advanced or Metastatic Hepatoma
Clinicalstudyresults.org (Mar 2007)
This Phase II multi-center study was conducted to assess the response rate and toxicity profile of single agent pemetrexed in first-line treatment of patients with advanced or metastatic hepatoma.
Lung Cancer
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Cisplatin-Based Chemotherapy Improves Survival in Non-Small Cell Lung Cancer
National Cancer Institute (Jun 2006)
Combined data from five large randomized clinical trials confirmed that cisplatin-based chemotherapy extends survival for patients with stage II or stage III non-small cell lung cancer. The benefit did not differ with different chemotherapy regimens, and was not affected by variables such as age, gender, or tumor type.
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Elderly Benefit From Chemotherapy After Surgery for Early Non-Small Cell Lung Cancer
National Cancer Institute (Jun 2006)
Elderly patients with early-stage non-small cell lung cancer who received chemotherapy following surgery lived longer than those who’d had surgery alone, without an increase in treatment-related toxicity or hospitalization. These results provide more evidence that chemotherapy should not be withheld from elderly patients on the basis of age alone
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Erlotinib (Tarceva®) Extends Survival in Advanced Lung Cancer
National Cancer Institute (Jul 2005)
Erlotinib (Tarceva®) prolonged survival in patients with advanced non-small cell lung cancer who had progressed after standard chemotherapy
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Erlotinib for the treatment of non-small cell lung cancer
NICE (Jan 2008)
Erlotinib is recommended as an alternative to docetaxel for patients with non-small-cell lung cancer (NSCLC) who have already tried one chemotherapy regimen but it has not worked. Erlotinib should be used only when the manufacturer provides the drug at the same overall treatment cost as docetaxel. This cost includes the cost of giving the drug, treatments for any side effects and the cost of monitoring patients to check that treatment is working. If the overall treatment cost is equal, specialists should discuss with patients the potential benefits and risks of erlotinib and docetaxel before deciding which treatment to use. Erlotinib is not recommended for people with locally advanced or metastatic NSCLC who cannot take docetaxel and have already tried one chemotherapy regimen but it has not worked. Erlotinib is not recommended for people who have already tried two chemotherapy regimens, including docetaxel, but they haven't worked.
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Lung cancer: diagnosis and treatment
NICE (Jan 2005)
The NICE lung cancer clinical guideline covers the full range of care that should be available from the NHS to adults who have lung cancer, or whose doctors think they may have lung cancer. They include how the diagnosis should be made and the treatments that should be offered at different times.
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Radiotherapy Can Prevent Spread of Small-Cell Lung Cancer to the Brain
National Cancer Institute (Jun 2007)
Radiation therapy to the head, given to patients who had responded to chemotherapy for advanced small-cell lung cancer, reduced by about two-thirds the risk that patients’ tumors would spread to the brain, thus extending patients’ lives. These findings are likely to change the standard of care for this group of patients.
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Sorafenib Increases the Risk of High Blood Pressure
National Cancer Institute (Feb 2008)
Combined data from nine studies showed that patients receiving the standard amount of sorafenib (Nexavar), an anticancer drug that interferes with a tumor’s blood supply, run a significant risk of high blood pressure (hypertension). Doctors should closely monitor these patients during treatment and prescribe anti-hypertension drugs as needed.
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Whole Brain Radiation May be Postponed in Cancer Patients with Limited Metastasis to the Brain
National Cancer Institute (Jun 2006)
Patients who received stereotactic radiosurgery for four or fewer contained metastases to the brain lived as long, and had comparable radiation side effects and mental functioning, as patients who were also treated with whole brain radiation. However, the radiosurgery-only patients had higher recurrence in their brain and were more likely to require salvage treatment.
Major Depressive Disorder
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A placebo- and paroxetine-controlled study of efficacy and safety
Roche: Clinical Trials (Jan 2006)
This double-blind randomized study compared the effect of RO0675930, paroxetine and placebo on the symptoms of major depressive disorder. Patients were randomized to receive either RO0675930 50 mg, 200 mg or 400 mg, paroxetine 20 mg or placebo; all drugs were given orally, once daily for 6 weeks.
Multiple Myeloma
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National Cancer Institute (Feb 2006)
In this randomized trial, multiple myeloma patients treated with high-dose chemotherapy and radiation therapy (HDT) followed by stem-cell transplantation fared no better than those treated with standard chemotherapy in terms of progression-free survival or overall survival. These findings conflict with earlier trials; further studies are required to clarify the issue.
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Lower Dose of Thalidomide May Be Just as Effective in Multiple Myeloma
National Cancer Institute (Jun 2006)
Cutting the daily dose of the drug thalidomide from 400 mg to 100 mg significantly reduced the drug’s potentially severe side effects in patients with multiple myeloma that had come back or stopped responding to treatment, and without a significant impact on survival
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Thalidomide a Beneficial Option for Elderly Multiple Myeloma Patients
National Cancer Institute (Dec 2007)
Patients aged 75 and over with newly diagnosed multiple myeloma who received the drug thalidomide in addition to standard therapy (melphalan and prednisone) survived on average 17.6 months longer than patients who received standard therapy plus a placebo. The thalidomide group suffered worse side effects, however, and was more likely to discontinue treatment. Thalidomide is a treatment option for older patients who can tolerate the drug’s side effects.
Non-Hodgkin's Lymphoma
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Clinicalstudyresults.org (Jan 2003)
The objective of this study was to evaluate the efficacy and safety of sibutramine 15 mg daily when given to obese subjects for up to 5 years.
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Roche: Clinical Trials (Aug 2005)
This was an open-label, multicenter, randomized study of the efficacy and safety of MabThera plus a chemotherapy regimen compared with a chemotherapy regimen alone in patients with diffuse large B-cell non-Hodgkin’s lymphoma. Patients were randomized to receive either CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or CHOP plus MabThera for 6 cycles.
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Initial Treatment with Rituximab is a New Standard for Elderly Patients with B-Cell Lymphoma
National Cancer Institute (Jul 2006)
Elderly patients with B-cell lymphoma stayed disease-free for significantly longer when they were treated with the drug rituximab. Patients benefited from rituximab whether they got it with their initial standard chemotherapy or as maintenance therapy afterward. These findings establish a new standard of care for the treatment of elderly patients with B-cell lymphoma.
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Radiation Might be Avoided for Older Patients with Good Prognosis Non-Hodgkin's Lymphoma
National Cancer Institute (Jan 2007)
Current standards call for radiation therapy in addition to chemotherapy in the treatment of localized, early-stage, aggressive non-Hodgkin’s lymphoma. But in this trial, chemotherapy alone was just as effective in promoting survival among patients over 60, suggesting that similar patients might be able to avoid the added toxicity of radiation therapy.
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Rituximab Benefits Younger Patients with Good-Prognosis Diffuse Large-B-Cell Lymphoma
National Cancer Institute (May 2006)
Addition of the drug rituximab (Rituxan®, a monoclonal antibody) to a standard chemotherapy regimen for diffuse large-B-cell lymphoma significantly increased survival for patients with good-prognosis disease who were younger than 60.
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Rituximab Helps Patients with Recurrent Lymphomas
National Cancer Institute (Jun 2006)
Two studies from Germany showed the targeted therapy rituximab (Rituxan®) to be effective in treating recurrent or refractory follicular and mantle cell lymphomas. In the first study, adding rituximab to a standard chemotherapy regimen improved response rates, progression-free survival, and possibly overall survival - when compared to chemotherapy alone. In the second related study, patients whose recurrent lymphoma had been responsive to the same rituximab combination had their outcomes further improved when they continued to receive rituximab-alone for maintenance.
Non-Small Cell Lung Cancer
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Roche: Clinical Trials (Jan 2007)
This was a multi-center, randomized, double-blind study to investigate the effect of adding two different doses of Avastin (bevacizumab) to cisplatin and gemcitabine on progression-free survival in patients with advanced or recurrent non-squamous non-small cell lung cancer.
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Erlotinib for the treatment of non-small cell lung cancer
Clinicaltrials.gov (Nov 2008)
Erlotinib is recommended as an alternative to docetaxel for patients with non-small-cell lung cancer (NSCLC) who have already tried one chemotherapy regimen but it has not worked. Erlotinib should be used only when the manufacturer provides the drug at the same overall treatment cost as docetaxel. This cost includes the cost of giving the drug, treatments for any side effects and the cost of monitoring patients to check that treatment is working. If the overall treatment cost is equal, specialists should discuss with patients the potential benefits and risks of erlotinib and docetaxel before deciding which treatment to use. Erlotinib is not recommended for people with locally advanced or metastatic NSCLC who cannot take docetaxel and have already tried one chemotherapy regimen but it has not worked. Erlotinib is not recommended for people who have already tried two chemotherapy regimens, including docetaxel, but they haven't worked. Healthcare professionals should not stop prescribing erlotinib for people who were already taking it when the guidance was issued. These patients should be able to carry on taking erlotinib until they and their specialist decide that it is the right time to stop treatment.
Obesity
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Clinicalstudyresults.org (Jan 2003)
The objective of this study was to evaluate the efficacy and safety of sibutramine 15 mg daily when given to obese subjects for up to 5 years.
Osteoarthritis
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The care and management of osteoarthritis in adults
Clinicaltrials.gov (Jan 2008)
The advice in the NICE guideline covers the treatment, advice and support that people who have osteoarthritis should be offered by their healthcare professional and when being referred to specialist care. This includes: * diagnosis * education * exercise and physiotherapy * medicines * alternative therapies * surgery. It does not specifically look at the care and management of related conditions (for example, rheumatoid arthritis and joint pain).
Osteoporosis
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NICE (Jan 2008)
Whether or not a postmenopausal woman with osteoporosis is offered one of these drugs to prevent bone fractures will depend on her age, her bone density and how many risk factors for fracture and indicators of fragile bones she has. In principle, alendronate is recommended as a possible treatment for preventing bone fractures in postmenopausal women who have had osteoporosis diagnosed but have not had a fracture. If a woman can't take alendronate, risedronate and etidronate are recommended under certain circumstances as possible alternative treatments to prevent fractures. If a woman can't take alendronate or either risedronate or etidronate, then strontium ranelate is recommended under certain circumstances as a possible alternative treatment to prevent fractures. Raloxifene is not recommended as a treatment for preventing fractures in postmenopausal women with osteoporosis who have not had a fracture.
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Roche: Clinical Trials (Jan 2000)
This was an open-label, single-arm, multicenter study in patients undergoing corticosteroid therapy. All patients received intermittent iv Bonviva, and changes in BMD and bone markers were measured.
Ovarian Cancer
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Impact of Intraperitoneal Chemotherapy on Quality of Life During Ovarian Cancer Treatment
National Cancer Institute (Feb 2007)
Women with ovarian cancer treated with a combination of intraperitoneal (IP) and intravenous (IV) chemotherapy reported more side effects and a lower quality of life during their treatment compared to women receiving IV chemotherapy only. However, at the end of one year only neurological symptoms (such as tingling in the hands and feet) remained worse for the IV/IP chemotherapy group; otherwise, the women’s quality of life was about the same
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Review Confirms Effectiveness of Intraperitoneal Chemotherapy for Advanced Ovarian Cancer
National Cancer Institute (Nov 2006)
Combined data from 60 randomized clinical trials of advanced ovarian cancer showed that multidrug chemotherapy using a platinum-based drug and a taxane-based drug delivered directly into the abdomen (intraperitoneal chemotherapy) can help women survive a median of 5.5 years.
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Ultrasound Expertise Important in the Diagnosis of Ovarian Cancer
National Cancer Institute (Feb 2008)
Improving the quality of diagnostic ultrasound scans could significantly reduce unnecessary surgeries in women with suspected ovarian cancer who, in fact, have benign disease, according to a study by British researchers.
Pancreatic
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Gemcitabine Plus Standard Chemoradiation Improves Survival in Patients with Pancreatic Head Tumors
National Cancer Institute (Jun 2006)
The combination of radiation therapy and the drug 5-flurouracil (5-FU) is frequently used in addition to surgery in the treatment of pancreatic cancer. In this trial, adding gemcitabine to this standard chemoradiation regimen improved overall survival in patients with the most common kind of pancreatic tumors: those located in the head of the pancreas.
Prostate Cancer
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Roche: Clinical Trials (Jan 2006)
This was an open-label, multicenter, phase II, single arm, efficacy and safety study of pertuzumab in patients with prostate cancer. Simon’s two-stage design was implemented to allow for early termination due to lack of efficacy. An interim analysis was carried out after the 23rd evaluable patient had undergone 3 cycles of treatment.
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Frozen Glove Reduces Skin and Nail Damage from Docetaxel Chemotherapy
National Cancer Institute (Jul 2005)
Patients who wore an experimental “frozen glove” to keep their hands very cold during intravenous chemotherapy with docetaxel (Taxotere®) had much less subsequent damage to the nails and skin of their hands, according to a French study
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Gabapentin Helps Hot Flashes From Prostate Cancer Treatment
National Cancer Institute (Jun 2007)
The drug gabapentin (Neurontin®) effectively reduced the intensity and duration of hot flashes in a clinical trial of more than 200 men receiving hormonal treatment for their prostate cancer.
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Higher Radiation Dose Reduces Recurrence of Local Prostate Cancer
National Cancer Institute (Sep 2005)
Men with early-stage prostate cancer who got higher doses of radiation were half as likely to see their cancer return in five years as men who received the conventional dose. This is the first large trial to show a high-dose radiation benefit in the treatment of low-risk patients.
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Post-Surgery Radiation of Some Benefit in Advanced Prostate Cancer
National Cancer Institute (Nov 2006)
Prostate cancer that has spread beyond the affected gland is likely to come back after surgery. A new study shows that radiation treatment after surgery can reduce the risk of recurrence by about 50 percent. However, such treatment does not help patients live any longer and many experience difficult side effects from the radiation
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Prostate cancer: diagnosis and treatment
Clinicaltrials.gov (Jan 2008)
This guideline covers the tests, treatment, care and support that men who have suspected or diagnosed prostate cancer should be offered. It does not specifically look at the care of men with rare cancers of the prostate (for example, small-cell carcinoma and rhabdomyosarcoma).
Rectal Cancer
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Chemoradiation Before Surgery Helps Prevent Local Relapse of Rectal Cancer
National Cancer Institute (Oct 2004)
Patients with clinical stage II or stage III cancer of the rectum who received radiation and chemotherapy before surgery had fewer problems afterwards and a lower risk that their cancer would come back in the rectum, compared with patients who had radiation and chemotherapy after surgery. However, the before-surgery approach did not reduce the risk of cancer recurring elsewhere in the body or result in patients’ living any longer
Renal Cell Cancer
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Roche: Clinical Trials (Jan 2007)
This was a multicenter, randomized, (2 treatment arms), double-blind study to compare the efficacy and safety of Avastin (bevacizumab) + interferon alfa-2a (IFN) versus placebo + IFN in patients with metastatic renal cell carcinoma. The interim analysis of overall survival and the final analysis of progression-free survival are reported here.
Respiratory tract infections
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Clinicaltrials.gov (Jan 2008)
This guidance is about the care and treatment of people with respiratory tract infections (RTIs) in the NHS in England and Wales. It explains guidance (advice) from NICE (the National Institute for Health and Clinical Excellence). It is written for adults and parents of children aged 3 months and older, but it may also be useful for families or carers or for anyone with an interest in the condition
Rhrumatoid arthritis
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"Abatacept for the treatment of rheumatoid arthritis "
Clinicaltrials.gov (Jan 2008)
Abatacept is not recommended for people with moderate to severe active rheumatoid arthritis who have already tried drugs known as disease-modifying anti-rheumatic drugs (including a 'TNF inhibitor'drug), which didn't work or weren't suitable. Healthcare professionals should not stop prescribing abatacept for people who were already taking it when the guidance was issued. These patients should be able to carry on taking abatacept until they and their specialist decide that it is the right time to stop treatment
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Abatacept for the treatment of rheumatoid arthritis
Clinicaltrials.gov (Jan 2008)
Abatacept is not recommended for people with moderate to severe active rheumatoid arthritis who have already tried drugs known as disease-modifying anti-rheumatic drugs (including a 'TNF inhibitor'drug), which didn't work or weren't suitable. Healthcare professionals should not stop prescribing abatacept for people who were already taking it when the guidance was issued. These patients should be able to carry on taking abatacept until they and their specialist decide that it is the right time to stop treatment
Stomach Cancer
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Adding Docetaxel Improves Survival in Stomach Cancer
National Cancer Institute (May 2005)
Addition of the drug docetaxel (Taxotere®) to other chemotherapy drugs used to treat advanced stomach cancer increased the number of patients surviving for at least two years. This finding offers a new treatment option for patients with this disease
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Limited Lymph Node Removal and Stomach Cancer
National Cancer Institute (Jun 2004)
Long-term follow-up of patients with stomach (gastric) cancer has shown that patients treated with more extensive surgery involving the removal of more lymph nodes did not live longer than those who received a more limited lymph node removal (dissection).
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Stomach Cancer Drug, S-1, Shows Promise in Japanese Trial
National Cancer Institute (Mar 2008)
In this Japanese clinical trial, patients with advanced, inoperable stomach cancer who received combination therapy with cisplatin and a drug called S-1 lived about two months longer than patients treated with S-1 alone. S-1 is not currently approved for use in the United States. Because S-1 is broken down by the body differently in patients of European and Japanese descent, many U.S. patients may not be able to tolerate the doses of the drug given in this study.
Stress
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Centerwatch (Jan 2006)
This was a randomized, double-blind, parallel group study to evaluate the efficacy and safety of 12 weeks’ treatment with alpha 1A/1L agonist in women with urinary incontinence.
Surgical site infection
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Prevention and treatment of surgical site infection
NICE (Jan 2008)
the advice in the NICE guideline covers: * adults and children who are going to have a cut through the skin for an operation. It does not specifically look at: * adults and children who are going to have an operation that does not involve a cut through the skin on the outside of the body * adults and children who are going to have procedures involving thintubes (called catheters) placed in blood vessels, tubes (called shunts) inserted into the body to divert fluid, thin flexible telescopes (called endoscopes) to view the inside of the body or metal pins used externally to treat broken bones.
Testicular Cancer
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Carboplatin May Be Less Toxic Than Radiation for Seminoma
National Cancer Institute (Jun 2008)
One shot of carboplatin appeared to be as effective as radiation therapy as a post-surgical treatment for early seminoma, a kind of testicular cancer. Carboplatin also appeared safer than radiation therapy, reducing the risk of second cancers. Further follow-up is needed to show whether the benefits last.
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Fewer CT Scans Needed after Surgery for Low-Risk, Early-Stage Testicular Cancer
National Cancer Institute (Jun 2006)
During the follow-up period after surgery, two computed tomography (CT) scans were just as effective as five CT scans in detecting relapse for patients with a certain kind of low-risk, early-stage testicular cancer
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Surgery May Prevent Rare Thyroid Cancer in At-Risk Children
National Cancer Institute (Nov 2005)
Forty-four of 50 children who carried a genetic mutation that causes a rare type of thyroid cancer, but who had no symptoms of the disease, remained disease-free five or more years after preventive surgery to remove the thyroid gland. However, longer follow-up is necessary to confirm that the complex procedure should be routinely done on all at-risk children.
Ulcerative colitis
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Infliximab for the treatment of acute exacerbations of ulcerative colitis
Clinicaltrials.gov (Jan 2008)
Infliximab is recommended as a possible treatment for people with acute, severely active ulcerative colitis only if: * ciclosporin is considered inappropriate for them, or * they are taking part in a research study (clinical trial)
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Infliximab for the treatment of acute exacerbations of ulcerative colitis
NICE (Jan 2008)
Infliximab is recommended as a possible treatment for people with acute, severely active ulcerative colitis only if: *ciclosporin is considered inappropriate for them, or *they are taking part in a research study (clinical trial)
Uterine Sarcoma
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Chemotherapy Superior to Whole-Abdominal Radiation Therapy for Uterine Sarcoma
National Cancer Institute (Jun 2006)
Chemotherapy with cisplatin and ifosfamide was more effective than whole-abdominal radiation therapy at extending survival in patients with uterine sarcoma. However, better therapies are still needed for patients with this rare form of uterine cancer.
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Ifosfamide Plus Paclitaxel Extends Life for Patients With Uterine Carcinosarcoma
National Cancer Institute (Feb 2007)
Women with a rare, aggressive form of uterine cancer who were treated with the drugs ifosfamide and paclitaxel lived a median of five months longer than women who were treated with ifosfamide alone.
Venous thromboembolism
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NICE (Jan 2008)
Dabigatran etexilate is recommended as a possible treatment to reduce the risk of venous thromboembolism in adults who have surgery to replace their hip or knee joint.
Vulvar Cancer
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Imiquimod May Help to Prevent Vulvar Cancer
National Cancer Institute (Apr 2008)
Women with a precancerous condition called vulvar intraepithelial neoplasia (VIN) were successfully treated with a drug that is applied to the affected areas as a cream. The drug, imiquimod (Aldara®), caused less discomfort and pain than standard surgical treatments. Although small, this study supports the conclusion that imiquimod should be the first-choice treatment for VIN.









