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NCT ID: NCT00513253 Withdrawn - Healthy Subjects Clinical Trials

A Phase I Study to Test Alternate Oral Formulations vs the Current Tablet Formulation of Lapatinib

Start date: April 2008
Phase: Phase 1
Study type: Interventional

This study is designed to estimate the relative bioavailability of alternative lapatinib oral formulations compared to the current tablet formulation.

NCT ID: NCT00594971 Withdrawn - Neoplasms Clinical Trials

A Shared Care Approach for Seriously Ill Cancer Patients Between General Practice, Discharge Department and a Specialist Palliative Care Team

Start date: April 2008
Phase: N/A
Study type: Interventional

Background: Approximately one third of all deaths in Denmark are caused by cancer. Both Danish and international research shows that the majority of terminally ill cancer patients wish to die at home. In Denmark only about 25% has this wish fulfilled. The General Practitioner (GP) has traditionally had the full responsibility for the palliative care of terminally ill cancer patients. In recent years changes have been made to the organisation of palliative care: some hospitals have set up specialised palliative care teams and in some areas of Denmark hospices have been established. Recent research defines a problem when it comes to communication between the hospital and general practice when the patient is being discharged. This is often done in a way that can cause the patient to feel "left in limbo", especially if it is not completely clear to the patient and his or her relatives who has the responsibility for the palliative care. Objective: 1. To describe consequences for patients, relatives and health care professionals of three different ways of organising palliative care 2. To collect data which describes patients who are candidates to a shared care approach between general practice and a specialised palliative care team 3. To collect data which describes the palliative phase (place of death and palliative care, admissions to hospital, involvement of GP and district nurse etc.) 4. To describe terminally ill cancer patients and their relatives expectations of the health care system 270 terminally ill cancer patients will be invited to take part in the study. Data will be collected by interview with patients and questionnaires for patients, relatives and involved health care professionals.

NCT ID: NCT00615524 Withdrawn - Clinical trials for Hormone-receptor Positive Breast Cancer

Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Start date: April 2008
Phase: Phase 2
Study type: Interventional

This study is being conducted to compare the efficacy and safety of exemestane alone or in combination with pazopanib in postmenopausal women who have hormone receptor positive breast cancer and have failed therapy with tamoxifen, anastrazole or letrozole.

NCT ID: NCT00627627 Withdrawn - Breast Cancer Clinical Trials

A Study to Evaluate the Antitumor Activity and Safety of IPI-504 in Patients With Advanced Breast Cancer

Start date: April 2008
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the antitumor activity following treatment with IPI-504 in patients with breast cancer.

NCT ID: NCT00643110 Withdrawn - Type 1 Diabetes Clinical Trials

Milk as Treatment for Hypoglycemia

Start date: April 2008
Phase: N/A
Study type: Interventional

Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.

NCT ID: NCT00653900 Withdrawn - Clinical trials for Perioperative Bleeding

Platelet Function Testing Help and Intraoperative Bleeding Risk for Patients Who Are on Plavix Prior to Surgery

Start date: April 2008
Phase:
Study type: Observational

A large number of patients are currently on Antiplatelet inhibition using aspirin or Plavix therapy (A Thieno pyridine - ADP mediated platelet inhibitor). A group of these patients often require Cardiac and/or Vascular surgical procedures. These patients are at a higher risk for perioperative bleeding complications and higher re-operation/re-exploration for bleeding and subsequent blood product transfusions. The aim of this protocol is to assess platelet function via the "Verify Now" device prior to surgery. The Verify Now device requires a small drop of fresh blood for each sample and is an FDA approved device. The investigators initial goal is to establish if a certain degree of platelet function abnormality can predict a higher bleeding complication or higher transfusions (Phase I, 20 patients). This initial study will allow us to determine a sample size for Phase II. Phase II will maintain the same protocol, however after completion of Phase I, a more accurate sample size determination can be made. Additionally, the investigators want to establish if knowledge of platelet dysfunction will change procedure technique or preparation to lower bleeding and/or lead to cancellation/rescheduling of procedure (Phase III). Participants will be those patients who are taking plavix and are undergoing vascular or cardiac surgery. They will undergo a platelet function evaluation measured as Platelet Response Unit (PRU) via the "verify now" device on admission/pre surgery. This test involves taking 1 drop of blood from the patient, one time, before the procedure. The Verify Now device is FDA approved. Perioperative bleeding will be assessed by absolute drop in hematocrit immediate post-op compared to the immediate preoperative value. An additional discharge hematocrit will be used if no blood products have been used during the initial hospital stay. Hematocrit evaluation via a complete blood count is a part of standard patient care. Additionally, utilization of blood products (factors, PLT, PRBC's, etc.) will be assessed. In order to conduct the research, patients will be identified by reviewing the OR schedule. All consecutive patients on ASA/Plavix will be mailed a letter in order to introduce them to the study. The letter provides a phone number to call if the patient does NOT want to receive a phone call from the investigative staff. This letter is uploaded under item 18-02 of the study application. If patients do not call the office, then the investigative staff will call the potential participants to introduce the study. Final consent will be completed in PACU on arrival at the hospital for planned surgical procedure. A Hematocrit will be performed on the consented patient preoperatively, immediately post-op, and at discharge. A PRU will be assessed using a few drops of the patients' blood preoperatively (PACU). Patients' records will be reviewed to assess use of blood products. No additional follow up is required. Patients' care will be no different than current standard of care, other than the 1 "verify now" test, which is done before the procedure.

NCT ID: NCT00661050 Withdrawn - Clinical trials for Cystitis, Interstitial

Treatment of Interstitial Cystitis/Painful Bladder Syndrome Using Alternative Techniques: Exercise, Meditation, Tai Chi

Start date: April 2008
Phase:
Study type: Observational

Complementary and alternative medicine (CAM) is the term for medical products and/or practices that are not part of the current standard of care. Standard care is what medical doctors, doctors of osteopathy and allied health professionals, such as registered nurses and physical therapists, practice. Alternative medicine means treatments that you use instead of standard ones. Complementary medicine means nonstandard treatments that you use along with standard ones. The purpose of this study is to determine whether there is any improvement in symptoms reported by patients with chronic painful bladder syndrome when participating in alternative medical therapy/ exercise and meditative techniques. The specific alternative techniques participants will be randomized to in this trial include: Tai Chi instruction or walking exercise combined with sitting meditation.

NCT ID: NCT00661336 Withdrawn - Melanoma (Skin) Clinical Trials

A Phase I Trial of Normothermic Isolated Limb Infusion (ILI) With Melphalan Plus Buthionine Sulfoximine (BSO) in Patients With Locally Advanced Malignant Melanoma

Start date: April 2008
Phase: Phase 1
Study type: Interventional

RATIONALE: Buthionine sulfoximine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving buthionine sulfoximine together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given as an isolated limb infusion together with buthionine sulfoximine in treating patients with persistent or recurrent stage III malignant melanoma.

NCT ID: NCT00661973 Withdrawn - Asthma Clinical Trials

Inhaled Corticosteroids on Airway Smooth Muscle in Asthma

Start date: April 2008
Phase: Phase 4
Study type: Interventional

The main objective is to evaluate how treatment with inhaled corticosteroids (ICS) affects the characteristics of airway smooth muscle (ASM) cells from asthmatic subjects. Our hypothesis is that airway smooth muscle cell dysfunction plays an important role in the pathogenesis of asthma, and that treatment with inhaled corticosteroids reverses the abnormalities in airway smooth muscle cell function.

NCT ID: NCT00662051 Withdrawn - Asthma Clinical Trials

Oral Contraceptives and Asthma Control

Start date: April 2008
Phase: N/A
Study type: Observational

Asthma is a chronic inflammatory disorder of the airways affecting approximately 15 million individuals in the U.S. The rate of asthma exacerbations among women is twice that of men after adolescence, and a large proportion of females with asthma report worsened asthma symptoms during different phases of the menstrual cycle. Hormonal influences have been hypothesized to account for these differences. Decreased peak flow rates and increased symptoms have been found in females during the premenstrual phase of the menstrual cycle when estrogen and progesterone levels are low. Estrogen and progesterone have both been found to reduce smooth muscle contractility and increase bronchial smooth muscle relaxation. A perimenstrual shift toward a Th2 (allergic) phenotype characterized by a decreased interferon-gamma to interleukin-10 ratio has been demonstrated in healthy women not using oral contraceptives compared to midcycle; however, the effect was blunted in healthy oral contraceptive pill users, implying hormonal modulation of the allergic phenotype. Several case reports have demonstrated a therapeutic benefit of oral contraceptives in decreasing asthma exacerbations and corticosteroid requirements. Human studies have demonstrated that estrogen decreases pro-inflammatory cytokine generation, neutrophil recruitment, and inhibits inducible nitric oxide synthase activity, which could lead to lower exhaled nitric oxide levels. The measurement of the fractional concentration of exhaled nitric oxide (FENO) is a non-invasive method to assess airway inflammation in adults and children with asthma. The hypotheses of the current study are that women using oral contraceptives will have lower FENO levels and better asthma control as assessed by the Asthma Control TestTM during different phases of the menstrual cycle. This study may identify clinically important changes in FENO levels and asthma control during the menstrual cycle and modification of these effects by oral contraceptive pills. This data may lead to future studies aimed at identifying therapeutic roles for hormones in asthma therapy in women.