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NCT ID: NCT00491296 Not yet recruiting - Bladder Cancer Clinical Trials

Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia

Start date: June 2007
Phase: N/A
Study type: Observational

PURPOSE: We determined whether Synergo therapy- intravesical chemotherapy instillation combined with hyperthermia instillation is associated with elevated prostate specific antigen (PSA). MATERIALS AND METHODS: We will treat 25 consecutive patients with bladder cancer with a 6-week course of Synergo therapy, followed by cystoscopy at 6 weeks. Blood samples for PSA determination will obtain before each synergo therapy application and at cystoscopy with each patient also serving as a control. Evaluating changes in PSA level in patients undergoing treatment with Synergo delivered local hyperthermia combined with intravesical instillation of Mitomycin C for adjuvant treatment or pt. with recurrent tu of bladder post TURT with BCGtreatment.

NCT ID: NCT00491270 Not yet recruiting - Premature Birth Clinical Trials

Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery

Start date: January 2011
Phase: Phase 3
Study type: Interventional

To determine whether screening of pregnant women with history of previous preterm delivery or with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth.

NCT ID: NCT00491231 Recruiting - Clinical trials for Orthostatic Hypotension

Is Orthostatic Hypotension Associated With Nondipping Hypertension

Start date: July 2007
Phase: N/A
Study type: Observational

The aim of the study is to evaluate whether orthostatic hypotension is associated with nondipping hypertension. Methods and patients: 400 subjects who are referred for 24hABPM will be filled questioner regarding their medical background and medications. All patients will be subjected to orthostatic test before connection to the 24 ABPM. The orthostatic changes in blood pressure and heart rate will be correlated to the changes in blood pressure and heart rate from day to night as recorded by the 24H ABPM.

NCT ID: NCT00490308 Not yet recruiting - Infertility Clinical Trials

The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment

Start date: August 2007
Phase: Phase 1
Study type: Interventional

To evaluate whether treatment with Estradiol supplementation during the luteal phase improves IVF outcomes Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a GnRH analog will receive 4 mg estradiol valerate in the luteal phase.Patient's followup will include E2 progesterone and BHCG 14 days after embryo transfer and vaginal ultrasound on day 21 and 28 after embryo transfer

NCT ID: NCT00490139 Completed - Neoplasms, Breast Clinical Trials

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ALTTO
Start date: May 16, 2007
Phase: Phase 3
Study type: Interventional

This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.

NCT ID: NCT00489723 Recruiting - Kidney Stones Clinical Trials

Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ?

Start date: May 2007
Phase: N/A
Study type: Observational

The purpose of this study is to determine if there is a role of prophylactic therapy with tamsulosin prior extracorporeal shock wave lithotripsy to avoid development of steinstrasse. 150 persons that will go to Extracorporeal shock wave lithotripsy will randomize to 2 groups. Group 1 -of 75 persons will recieve tamsulosin 0.4 mg x 1/d 2 days before the lithotripsy . Group 2 - of 75 persons will not recieve tamsulosin. 48 hour after the ESWL all 2 group will take abdominal radiograph to evaluate the presence of steinstrasse.

NCT ID: NCT00489112 Recruiting - Clinical trials for Distal Ureterolithiasis

The Use of Medical-Expulsive Therapy With Alfuzocine xl 10mg x1/d for Distal Ureterolithiasis.a Randomized Prospective Study

Start date: n/a
Phase: Phase 4
Study type: Interventional

We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m. 75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.No significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.Randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. Potential side effects and complications of the drugs were discussed. The expulsion rate will the primary end-point of this study.

NCT ID: NCT00488774 Terminated - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

Start date: August 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).

NCT ID: NCT00488631 Completed - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: September 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.

NCT ID: NCT00488085 Recruiting - Clinical trials for Crohn’s Disease, Obesity

Crohn’s Disease, Obesity and Disease Severity

CROHN_OBESE
Start date: June 2007
Phase: N/A
Study type: Observational

The aim of our study is to suggest possible underlying mechanisms for the observed clinical differences in disease severity and behavior of overweight and obese patients with crohn's disease(BMI > 25 kg/m²)as compare to non-obese crohn's patients with a normal or low weight ( BMI ≤ 25) by measuring metabolic\nutritional variables and cytokine levels.