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A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Ulcerative Colitis (UC)

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

Начало: 29.04.2013 Край: 01.06.2028 Възраст: 18–99 г.

Australia, Belgium, Canada +16 AbbVie NCT01848561

Активно (без набиране)

Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

Prostate Cancer

Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to four-year biochemical failure (PSA failure) by Phoenix definition post-treatment completion.

Начало: 04.04.2013 Край: 01.02.2027 Възраст: 35–85 г. Лечение

Australia, Italy, United States University of Miami NCT01794403

Активно (без набиране)

Survivorship of Attune Primary Total Knee Prosthesis

Noninflammatory Degenerative Joint Disease

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

Начало: 01.02.2013 Край: 01.02.2030 Възраст: 22–75 г. Лечение

Australia, Belgium, Canada +8 DePuy International NCT01754363

Активно (без набиране)

Continuous Monitoring of Prostate Position During Radiotherapy

Prostate Cancer

This study is investigating measurement of prostate motion during radiotherapy using the implanted gold markers. If motion is greater than 3mm then the beam will be stopped and position corrected (gating).

Начало: 01.01.2013 Край: 30.06.2028 Лечение

Australia Royal North Shore Hospital NCT01742403

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PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

Rheumatoid Arthritis With Adequate Bone Quality Inflammatory Arthritis Osteoarthritis, Hip Avascular Necrosis +2

This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.

Начало: 01.01.2013 Край: 01.12.2028 Възраст: 18–75 г.

Australia, Belgium, Canada +5 Zimmer Biomet NCT03372278

Активно (без набиране)

Depth of Anaesthesia and Long-term Survival: The Balanced Anaesthesia Follow-up Study

Post-Operative Confusion Long Term Adverse Effects Surgery--Complications Cognitive Dysfunction, Postoperative

Anaesthetic depth and complications after major surgery: an international, randomised controlled trial - The BALANCED trial. In this large, international, randomised controlled trial that enrolled patients aged 60 years and over with significant comorbidity and at increased risk of complications after major surgery, we found no evidence that light general anaesthesia (bispectral index 50) was superior to deep general anaesthesia (bispectral index 35) in reducing 1-year mortality. The BALANCED long term follow up study will look at whether depth of anesthesia affects long term (beyond 1 year) survival. The primary hypothesis is that targetting BIS 50 will result in superior long term survival compared to targetting BIS 35. The two secondary hypotheses are that BIS titration to BIS 50 will 1. reduce local cancer recurrence or metastatic spread and consequently improve long-term survival 2. reduce postoperative delirium and associated cognitive impairment and consequently improve long-term survival Both these mechanisms would be expected to take longer to manifest as reduced survival than 1-year all-cause mortality primary outcome in the Balanced trial. Trials of cancer outcomes often use 5-year survival or similar timeframes to determine evidence of clinical benefit. A steeper cognitive trajectory due to intermediate outcomes such as delirium and cognitive impairment may take longer than 1 year to produce a clinically important difference in survival 30. The 10.6% relative risk reduction seen in the Balanced trial could translate to a statistically and clinically meaningful survival difference in this high-risk population. This population may have 5-year survival of \~80% translating to an absolute survival difference of \~2% potentially (if the \~10% RRR is maintained beyond 1 year). The alternative is that there is no long-term mortality difference which would provide continuing clinical guidance of the safety of current practice in patients who are not at high risk of delirium. This study could provide a rationale for trials in larger populations (such as the total Balanced trial population) or targeted subgroups such as cancer and delirium to provide further mechanistic insights. Long-term survival is an important patient-centred outcome. The mechanisms described above may manifest in longer-term outcomes providing a clear rationale for the current trial.

Начало: 19.12.2012 Край: 31.08.2026 Възраст: от 60 г.

New Zealand Auckland City Hospital NCT04965324

Активно (без набиране) Фаза 2/3

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

Alzheimers Disease Dementia Alzheimers Disease, Familial

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

Начало: 01.12.2012 Край: 01.07.2028 Възраст: 18–80 г. Лечение

Argentina, Australia, Brazil +12 Washington University School of Medicine NCT01760005

Активно (без набиране) Фаза 2

Improving the Treatment for Women With Early Stage Cancer of the Uterus

Complex Endometrial Hyperplasia With Atypia Grade 1 Endometrial Endometrioid Adenocarcinoma

Currently the standard treatment for early stage endometrial cancer or endometrial hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and removal of both ovaries. While highly effective, this surgery carries significant side effects for: * young women who still wish to have children and would lose fertility; and * women with one or more disorders (or diseases) in addition to the early stage endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are at risk for surgical complications making surgery unsafe. This study will access a new approach to the treatment of endometrial cancer to spare women of having to undergo major surgery that may be unwanted or unnecessary. Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement therapy (HRT). However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. This research project will test to see if Mirena is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. Metformin is approved in Australia to treat Diabetes. However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an experimental treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. This means that it must be tested to see if it is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. Weight loss interventions are feasible and safe, and already being implemented by gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight induces a large biological effect (for example reduces incidence of diabetes by 58%, and hypertension by 26%).

Начало: 01.12.2012 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, New Zealand Queensland Centre for Gynaecological Cancer NCT01686126

Активно (без набиране) Фаза 3

Prostate Advances in Comparative Evidence

Prostate Cancer

This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.

Начало: 07.08.2012 Край: 01.12.2027 Възраст: от 18 г. Лечение

Canada, Ireland, New Zealand +1 Royal Marsden NHS Foundation Trust NCT01584258

Активно (без набиране) Фаза 2

A Study of LY2784544 in Participants With Myeloproliferative Neoplasms

Neoplasms, Hematologic

The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an intolerance to, failure of primary response to, or have demonstrated disease progression while on ruxolitinib.

Начало: 22.05.2012 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Canada, France +5 Eli Lilly and Company NCT01594723

Активно (без набиране)

Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®

Invasive Ductal Carcinoma Ductal Carcinoma in Situ

The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.

Начало: 08.05.2012 Край: 31.12.2029 Възраст: от 40 г. Лечение

Australia, Portugal, United States Xoft, Inc. NCT01644669

Активно (без набиране) Фаза 3

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

B Acute Lymphoblastic Leukemia B Acute Lymphoblastic Leukemia, BCR-ABL1-Like Central Nervous System Leukemia Testicular Leukemia

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

Начало: 29.02.2012 Край: 03.10.2026 Възраст: 1–31 г. Лечение

Australia, Canada, Ireland +4 National Cancer Institute (NCI) NCT02883049

Активно (без набиране) Фаза 2

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)

Metastatic Tumors

Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with older treatments. This improvement could help by reducing side effects and by improving the chance of controlling the cancer by more precisely treating the cancer. The purpose of this study is to compare SABR with current approaches of chemotherapy and conventional radiotherapy to assess the impact on overall survival and quality of life.

Начало: 01.11.2011 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, Canada, Netherlands +1 London Health Sciences Centre Research Institute OR Law NCT01446744

Активно (без набиране) Фаза 3

Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Acute Myeloid Leukemia Leukemia Cutis Myeloid Neoplasm Myeloid Sarcoma

This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.

Начало: 20.06.2011 Край: 30.09.2027 Възраст: до 29 г. Лечение

Australia, Canada, New Zealand +2 National Cancer Institute (NCI) NCT01371981

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Global Registry for Endovascular Aortic Treatment (GREAT)

Multiple Pathologies

Prospective, observational Registry to obtain data on device performance and clinical outcomes.

Начало: 01.12.2010 Край: 01.06.2027

Australia, Brazil, Italy +1 W.L.Gore & Associates NCT01658787

Активно (без набиране) Фаза 3

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

Acute Lymphoblastic Leukemia Adult B Lymphoblastic Lymphoma Ann Arbor Stage I B Lymphoblastic Lymphoma Ann Arbor Stage II B Lymphoblastic Lymphoma +6

This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Начало: 09.08.2010 Край: 31.03.2026 Възраст: 1–30 г. Лечение

Australia, Canada, Ireland +4 Children's Oncology Group NCT01190930

Активно (без набиране) Фаза 3

Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

Anaplastic Ependymoma Brain Ependymoma Cellular Ependymoma Clear Cell Ependymoma +2

The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and then either achieved a complete response or went on to have a complete resection would also benefit from maintenance chemotherapy. Children ages 1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that were not randomized. One arm studied patients with Grade II tumors located in the supratentorial compartment that were completely resected. One arm studied patients with residual tumor and those patients all received maintenance chemotherapy after focal radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Начало: 07.05.2010 Край: 31.03.2026 Възраст: 12–21 г. Лечение

Australia, Canada, New Zealand +1 Children's Oncology Group NCT01096368

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BAsel Syncope EvaLuation (BASEL IX) Study

Syncope

Syncope is a major health problem. In the emergency department (ED), the management of patients with syncope still remains a clinical challenge because underlying diseases and prognosis can be extremely various. Structural heart disease and primary electrical disorders are major risk factors for sudden cardiac death and mortality in patients with syncope. In contrast, patients with reflex syncope and exclusion of structural heart disease have an excellent prognosis. Therefore The investigators test the hypothesis that the use of a meticulous patient history, clinical examination and novel biomarkers can improve the rapid and accurate diagnosis of cardiac syncope in patients presenting to the ED and is able to improve risk stratification regarding adverse outcomes. The prospective multicenter cohort study is designed to enroll 720 patients presenting with transient loss of consciousness within the last 12 hours to the ED. Blood samples for the measurement of novel biomarkers will be obtained at presentation. All patients will be contacted by phone at 6, 12 and 24 months to determine major adverse events (death, resuscitation, recurrence of syncope, hospitalization for syncope).

Начало: 01.04.2010 Край: 01.12.2025 Възраст: от 40 г.

Argentina, Australia, Germany +6 University Hospital, Basel, Switzerland NCT01548352

Активно (без набиране) Фаза 2

Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Ovarian Cancer

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

Начало: 04.02.2010 Край: 31.12.2026 Възраст: 18–125 г. Лечение

Australia, Belgium, Canada +10 AstraZeneca NCT01081951

Активно (без набиране) Фаза 3

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

PRETEXT I Hepatoblastoma PRETEXT II Hepatoblastoma PRETEXT III Hepatoblastoma PRETEXT IV Hepatoblastoma

This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.

Начало: 14.09.2009 Край: 19.03.2026 Възраст: до 21 г. Лечение

Australia, Brazil, Canada +3 National Cancer Institute (NCI) NCT00980460

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