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NCT ID: NCT00195559 Completed - Clinical trials for Premenstrual Syndrome

Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

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

The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.

NCT ID: NCT00195546 Completed - Menopause Clinical Trials

Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

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

Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

NCT ID: NCT00195468 Completed - Kidney Failure Clinical Trials

Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

Start date: March 2004
Phase: Phase 4
Study type: Interventional

Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).

NCT ID: NCT00195455 Completed - Postmenopause Clinical Trials

Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.

Start date: February 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.

NCT ID: NCT00195351 Completed - Appendicitis Clinical Trials

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

Start date: September 2005
Phase: Phase 4
Study type: Interventional

This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).

NCT ID: NCT00192647 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Induction Dosing With Peginterferon Alfa-2a (40KD) and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1

Start date: September 2004
Phase: Phase 4
Study type: Interventional

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with Pegasys and ribavirin, compared to standard-dose treatment without induction dosing, in treatment-naive participants with CHC, genotype 1. The anticipated time on study treatment is 48 weeks, and the target sample size is 500 or more individuals.

NCT ID: NCT00191854 Completed - Breast Cancer Clinical Trials

Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line

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

The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.

NCT ID: NCT00191620 Completed - Clinical trials for Non-Small-Cell Lung Carcinoma

Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.

Start date: March 2004
Phase: Phase 2
Study type: Interventional

The purposes of this study are to determine: How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer. The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.

NCT ID: NCT00191152 Completed - Breast Cancer Clinical Trials

A Phase III Trial For Patients With Metastatic Breast Cancer

Start date: February 2002
Phase: Phase 3
Study type: Interventional

This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

NCT ID: NCT00191100 Completed - Cancer of Cervix Clinical Trials

Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

Start date: May 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.