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NCT ID: NCT00403026 Recruiting - Clinical trials for Proliferative Diabetic Retinopathy

Intravitreal Bevacizumab for Retinal Disorders

Start date: August 2006
Phase: N/A
Study type: Interventional

Bevacizumab is an anti-VEGF agent used in approved for use in metastatic colorectal carcinoma (FDA Approved). This study analyzes the safety and efficacy of off-label Intravitreal Injection of bevacizumab (Avastin) for CNVM, Macular oedema due to diabetic retinopathy, vascular occlusion and other retinal disorders.

NCT ID: NCT00358943 Recruiting - Gaucher Disease Clinical Trials

International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry

Start date: April 1, 1991
Phase:
Study type: Observational [Patient Registry]

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The objectives of the Registry are: - To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. - To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. - To characterize the Gaucher disease population. - To evaluate the long-term effectiveness of imiglucerase and of eliglustat. Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

NCT ID: NCT00314483 Recruiting - Clinical trials for Graft vs Host Disease

Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of Graft Versus Host Disease

Start date: June 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Mesenchymal stem cells (MSC) have been shown to have immunosuppressive properties. Following a bone marrow/peripheral blood stem cell transplant, a proportion of patients develop a condition called ‘graft versus host disease’ (GVHD). In this condition the transplanted cells recognize the recipient as foreign and bring about an immune-mediated destruction of tissues. The treatment for this condition is to use drugs that will cause immunosuppression. A small subset of these patients develop a severe form of GVHD (Grade III or IV) which, in spite of the best currently available treatment, is associated with eventual death in more than 90% of cases. The investigators propose to use infusions of expanded MSC from the donor to treat this condition. A few reports on this approach have already been published in peer reviewed journals and preliminary results appear to be promising. The investigators are also aware that larger trials have been initiated to study this. After getting written informed consent, the investigators will infuse expanded MSC into patients who develop steroid-resistant GVHD.

NCT ID: NCT00231400 Recruiting - Pompe Disease Clinical Trials

Pompe Disease Registry Protocol

Start date: September 15, 2004
Phase:
Study type: Observational [Patient Registry]

The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. The objectives of the Registry are: - To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. - To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. - To characterize the Pompe disease population. - To evaluate the long-term effectiveness of alglucosidase alfa.

NCT ID: NCT00216268 Recruiting - Clinical trials for Japanese Encephalitis

Treatment of Japanese Encephalitis

Start date: July 2005
Phase: Phase 2
Study type: Interventional

Japanese encephalitis is the single largest cause of viral encephalitis in the world today. It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and south east Asia. There is presently no antiviral drug of proven benefit for this illness and treatment is mostly supportive. The drug Ribavirin is already in the market in use for other indications. It has been found useful in West Nile encephalitis and various hemorrhagic fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese encephalitis. To the best of our knowledge, this is the first such trial in the world. The study hypothesis is that children treated with ribavirin will be no different from those getting placebo in terms of mortality, length of hospital stay, days to return to consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month sequelae rate.

NCT ID: NCT00196742 Recruiting - Fabry Disease Clinical Trials

Fabry Disease Registry & Pregnancy Sub-registry

Start date: July 31, 2001
Phase:
Study type: Observational [Patient Registry]

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The primary objectives of the Registry are: - To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease; - To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; - To characterize and describe the Fabry population as a whole; - To evaluate the long-term safety and effectiveness of Fabrazyme® Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

NCT ID: NCT00193843 Recruiting - Mouth Neoplasms Clinical Trials

Oral Cancer Adjuvant Therapy (OCAT) Trial

Start date: June 2005
Phase: Phase 3
Study type: Interventional

To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead of 5 fractions / week improves local-regional control and / or overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral cavity.

NCT ID: NCT00193817 Recruiting - Cancer of Esophagus Clinical Trials

Three Field Radical Esophagectomy Versus Two Field Esophagectomy - a Prospective Trial

Start date: January 2005
Phase: Phase 3
Study type: Interventional

Surgery is the standard treatment for esophageal (food pipe) cancer. Esophageal cancer is known to spread to the lymph nodes (glands) adjacent to the esophagus. The extent of lymph nodes that need to be removed along with removal of the esophagus is a controversial topic. The basic surgery will remain the same i.e., the foodpipe in the chest will be removed and a new substitute will be created from the stomach and joined to the foodpipe in the neck. This will involve incisions in the chest, abdomen and neck. We intend to compare two types of lymphadenectomy (removal of lymph nodes) - the two field lymphadenectomy, whereby the lymph nodes in the abdomen and the lower half of the chest will be removed and three field lymphadenectomy, wherein lymph nodes in the abdomen, the whole chest and the lower neck will be removed. Both these procedures are practised widely worldwide and there is no definite scientific evidence showing the superiority of either of them. We are conducting this study to see whether one of these procedures is superior to the other. Seven hundred patients are expected to participate in this study.

NCT ID: NCT00144794 Recruiting - Clinical trials for Mucopolysaccharidosis I (MPS I)

Mucopolysaccharidosis I (MPS I) Registry

Start date: November 20, 2003
Phase:
Study type: Observational

The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities. The objectives of the Registry are: - To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase) - To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I - To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care

NCT ID: NCT00122746 Recruiting - Clinical trials for Cancer of the Cervix

Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients

Start date: December 2004
Phase: Phase 3
Study type: Interventional

The researchers plan: - To undertake clinical studies of radiotherapy with or without the administration of the chemotherapeutic agent cisplatin, known to be a radiosensitizer; - To perform pre-clinical studies of the radiosensitivity of human fibroblasts and cervical cancer cell lines in culture, with or without the addition of various HIV proteins or protease inhibitors, in order to determine the extent of any cellular radiosensitizing properties of these molecules; - To develop strategies for sensitizing tumour cells to radiation, specifically by down-regulating specific viral proteins that are known to be factors associated with resistance to radiotherapy.