ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00660907
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin efficacy safety metformin Type 2 diabetes
Sponsor: AstraZeneca
Start date: 2008-03-01; Completion date: 2013-01-01
Enrollment: 1217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Detailed description:

Arms: arm 1: dapagliflozin plus metformin arm 2: glipizide plus metformin
Interventions: intervention 1: dapagliflozin intervention 2: glipizide intervention 3: metformin hydrochloride
Intervention descriptions: intervention 1: Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks intervention 2: Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks intervention 3: Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks

Protocol documents:
Clinical trial NCT00806156
Conditions: Tumor Ovarian Cancer
Sponsor: Nektar Therapeutics
Start date: 2008-10-01; Completion date: 2013-01-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced platinum-resistant ovarian cancer.

Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 145 mg/m\^2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional patients.

Detailed description:

Arms: arm 1: NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients. arm 2: NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Interventions: intervention 1: NKTR-102 q14d intervention 2: NKTR-102 q21d
Intervention descriptions: intervention 1: NKTR-102 given on a q14 day schedule intervention 2: NKTR-102 given on a q21 day schedule

Protocol documents:
Clinical trial NCT00853827
Conditions: Coronary Artery Disease (CAD) Coronary Atherosclerosis
Keywords: CAD coronary artery disease coronary atherosclerosis coronary angiography IVUS intravascular ultrasound plasma renin activity renin angiotensin aldosterone system, direct renin inhibitors coronary atheroma
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2013-01-01
Enrollment: 613 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

Detailed description:

Arms: arm 1: None arm 2: Aliskiren 300 mg
Interventions: intervention 1: Placebo intervention 2: Aliskiren
Intervention descriptions: intervention 1: Placebo intervention 2: 300 mg

Protocol documents:
Clinical trial NCT01178125
Conditions: Contraception Female Contraception
Keywords: Pregnancy Prevention Oral Contraceptives
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-08-01; Completion date: 2013-01-01
Enrollment: 2858 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.

Detailed description:

Arms: arm 1: desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
Interventions: intervention 1: DR-102
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01289782
Conditions: Hepatitis C
Keywords: Hepatitis C TMC435 HCV Hep C Genotype 1
Sponsor: Janssen R&D Ireland
Start date: 2011-02-01; Completion date: 2013-01-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.

Detailed description:
This is a randomized, double-blind (neither physician nor participants know the name of the assigned drug), placebo-controlled study of TMC435 in participants who are infected with genotype 1 hepatitis C virus (HCV), who have never received treatment for HCV infection before. Participants in this study will also receive two other drugs for their HCV infection called peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV). The purpose of the study is to investigate if TMC435 is superior to placebo in reducing plasma levels of HCV ribonucleic acid (RNA) to an undetectable level 12 weeks after the end of treatment. For the first 12 weeks, participants will take either TMC435 or placebo, plus PegIFNα-2a and RBV. For the next 12 weeks, participants will take PegIFN alpha-2a and RBV only. After that, some participants will continue to take PegIFN alpha-2a and RBV for up to 24 additional weeks and some will stop taking PegIFN alpha-2a and RBV depending on response-guided treatment criteria. The study doctor will inform each participant about how to take their study medication and when they should stop taking it. After a participant stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. The total duration of the study is 78 weeks (including screening). Participants will be monitored for safety throughout the study.

Arms: arm 1: TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 24 or 48 weeks arm 2: Placebo 150 mg capsule once daily for 12 weeks in addition to PegIFNα-2a and RBV for 48 weeks
Interventions: intervention 1: Placebo intervention 2: TMC435 intervention 3: Peginterferon alpha-2a (PegIFN alpha-2a) intervention 4: Ribavirin (RBV)
Intervention descriptions: intervention 1: 150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 48 weeks intervention 2: 150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 24 or 48 weeks intervention 3: One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks. intervention 4: 200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.

Protocol documents:
Clinical trial NCT00025506
Conditions: Recurrent Uterine Corpus Sarcoma Uterine Carcinosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2001-09-01; Completion date: 2013-01-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well thalidomide works in treating patients with carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or disappear but may still be in the body) despite treatment. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

Detailed description:
OBJECTIVES: Primary I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine carcinosarcoma.

II. Determine the nature and degree of toxicity of this drug in these patients.

Secondary I. Determine the partial and complete response rates in patients treated with this drug.

II. Determine the duration of PFS and overall survival of patients treated with this drug.

III. Determine the effect of this drug on initial performance status and histological grade in these patients.

IV. Correlate serum and plasma biomarkers, including vascular endothelial growth factor and basic fibroblast growth factor, with clinical outcome (i.e., PFS) in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 3 years.

Arms: arm 1: Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Thalidomide
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given orally

Protocol documents:
Clinical trial NCT00070317
Conditions: Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Stage I Cervical Cancer
Sponsor: Gynecologic Oncology Group
Start date: 2004-06-01; Completion date: 2013-01-01
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.

Detailed description:
OBJECTIVES:

I. Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using preoperative or intraoperative lymphatic mapping, in patients with stage IB1 cervical cancer.

II. Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients.

OUTLINE: This is a multicenter study.

Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.

Arms: arm 1: Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Interventions: intervention 1: Isosulfan Blue intervention 2: Lymph Node Mapping intervention 3: Lymphangiography intervention 4: Methylene Blue intervention 5: Radionuclide Imaging intervention 6: Sentinel Lymph Node Biopsy intervention 7: Technetium Tc-99m Sulfur Colloid intervention 8: Therapeutic Conventional Surgery
Intervention descriptions: intervention 1: Undergo lymphangiography using isosulfan blue or methylene blue intervention 2: Undergo lymphatic mapping intervention 3: Undergo lymphangiography using isosulfan blue or methylene blue intervention 4: Undergo lymphangiography using isosulfan blue or methylene blue intervention 5: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid intervention 6: Undergo complete pelvic and low para-aortic lymphadenectomy intervention 7: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid intervention 8: Undergo radical hysterectomy

Protocol documents:
Clinical trial NCT00084747
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage II multiple myeloma stage III multiple myeloma
Sponsor: Jonsson Comprehensive Cancer Center
Start date: 2004-06-01; Completion date: 2013-01-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving bortezomib as maintenance therapy after autologous stem cell transplantation may kill more cancer cells and prolong remission.

PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma.

Detailed description:
OBJECTIVES:

* Determine response rate, as defined by resolution of bone marrow plasmacytosis and monoclonal paraproteinemia, in the first year after autologous peripheral blood stem cell transplantation in patients with intermediate or advanced multiple myeloma treated with adjuvant bortezomib.
* Compare progression-free survival of patients treated with adjuvant bortezomib with historical controls treated with autologous transplantation alone.
* Determine the toxicity of this drug in these patients (phase I).

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.

Arms: arm 1: None
Interventions: intervention 1: bortezomib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00166166
Conditions: Hyperlipidemia
Keywords: hyperlipidaemia EDHF FMD
Sponsor: Emory University
Start date: 2002-07-01; Completion date: 2013-01-01
Enrollment: 174 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.

Detailed description:
The vascular endothelium synthesizes at least four potent vasodilator substances: nitric oxide (NO), prostacyclin, carbon monoxide and endothelium-derived hyperpolarizing factor (EDHF) that contribute to vasodilator tone, and to inhibition of platelet activation and inflammation. EDHF release is stimulated by receptor-dependent agonists such as acetylcholine and bradykinin (BK), and leads to hyperpolarization of the underlying smooth muscle cells presumably by opening Ca2+-activated K+ channels. Indirect pharmacological evidence suggests that EDHF is a cytochrome P450-derived arachidonic acid metabolite, presumably an epoxide. Although the pivotal role of NO to conduit vessel dilation in response to acute increases in shear stress is well known, its' contribution to dilation with sustained increases in flow are minimal, and may be due to EDHF release.

Arms: arm 1: Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine arm 2: Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
Interventions: intervention 1: Tetraethylammonium (TEA) intervention 2: L-NG-monomethyl Arginine (L-NMMA) intervention 3: Bradykinin intervention 4: Sodium nitroprusside intervention 5: Acetylcholine intervention 6: Saline intervention 7: Fluconazole
Intervention descriptions: intervention 1: 5 minute intra-arterial infusion of Tetraethylammonium at 1 mg/min intervention 2: 5 minute intra-arterial infusion of L-NMMA 8 μmol/min intervention 3: Intra-arterial infusion of bradykinin at 100, 200, and 400 ng/min. Each dose will be given for 5 minutes. intervention 4: Intra-arterial infusion of sodium nitroprusside at 1.6 and 3.2 mg/min. Each dose will be given for 5 minutes. intervention 5: Intra-arterial infusion of acetylcholine at 7.5, 15 and 30 μg/min. Each dose will be given for 5 minutes. intervention 6: 5 minute intra-arterial infusion of 0.9% saline at 2.5ml/min intervention 7: 5 minute intra-arterial infusion of fluconazole at 0.4 mg/L/min

Protocol documents:
Clinical trial NCT00217399
Conditions: Recurrent Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-06-01; Completion date: 2013-01-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib together with anastrozole may reduce drug resistance and allow the tumor cells to be killed. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with anastrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the clinical benefit rate of sorafenib in combination with anastrazole in women with estrogen receptor- and/or progesterone receptor-positive metastatic breast cancer.

II. Determine the recommended phase II dose of sorafenib when administered with anastrozole in these patients.

SECONDARY OBJECTIVES:

I. Determine the toxic effects of this regimen in these patients. II. Determine the changes in Raf-MAPK and VEGF-signaling pathways in tumor tissue and stroma before and after treatment with this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of sorafenib.

PHASE I: Patients receive oral sorafenib twice daily and oral anastrozole once daily on days 1-28.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.

PHASE II: Patients receive sorafenib at the MTD and anastrozole as in phase I.

After completion of study treatment, patients are followed every 4-8 weeks.

Arms: arm 1: PHASE I: Patients receive oral sorafenib twice daily and oral anastrozole once daily on days 1-28.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.

PHASE II: Patients receive sorafenib at the MTD and anastrozole as in phase I.
Interventions: intervention 1: sorafenib tosylate intervention 2: anastrozole
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT00280241
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia Fludarabine Cyclophosphamide Rituximab
Sponsor: University of Pittsburgh
Start date: 2004-06-01; Completion date: 2013-01-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study will look at the effects (good or bad) of administering cyclophosphamide, fludarabine, and rituximab. Clinical studies with combination therapy have shown higher response rates than using single drugs, and this study will evaluate the side effects and effectiveness of this combination.

Detailed description:
This study is designed to expand on the highly successful combination of rituximab, fludarabine and cyclophosphamide for patients with previously untreated CLL. Responses in the range of 90-98% with 55% complete responses are reported. However, bone marrow toxicity has been a significant problem. This trial is designed to reduce the bone marrow toxicity by decreasing the doses of fludarabine and cyclophosphamide, but doubling the dose of rituximab with a maintenance dose of rituximab for up to two years, to maintain or even enhance efficacy.

Arms: arm 1: None
Interventions: intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Rituximab
Intervention descriptions: intervention 1: Fludarabine is usually administered by IV infusion over 30 minutes or longer. intervention 2: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour. intervention 3: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.

Protocol documents: