ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00768989
Conditions: HIV
Keywords: Combination Therapy
Sponsor: Bristol-Myers Squibb
Start date: 2008-11-01; Completion date: 2010-05-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

Detailed description:

Arms: arm 1: Atazanavir 300 mg twice daily + Raltegravir 400 mg twice daily arm 2: Atazanavir, 300 mg once daily, + Ritonavir, 100 mg once daily, + Tenofovir 300 mg/Emtricitabine, 200 mg once daily
Interventions: intervention 1: Atazanavir intervention 2: Raltegravir intervention 3: Atazanavir intervention 4: Ritonavir intervention 5: Tenofovir/Emtricitabine
Intervention descriptions: intervention 1: Capsules, Oral, 300 mg, twice daily, 96 weeks intervention 2: Tablet, Oral, 400 mg, twice daily, 96 weeks intervention 3: Capsules, Oral, 300 mg, once daily, 96 weeks intervention 4: Capsules, Oral, 100 mg, once daily, 96 weeks intervention 5: Tablet, Oral, 300-mg Tenofovir/200-mg Emtricitabine, once daily, 96 weeks

Protocol documents:
Clinical trial NCT00859898
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Metformin Dapagliflozin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs
Sponsor: AstraZeneca
Start date: 2009-04-01; Completion date: 2010-05-01
Enrollment: 1093 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study

Detailed description:

Arms: arm 1: Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks

Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks arm 2: Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.

Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks. arm 3: Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks

Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
Interventions: intervention 1: Dapagliflozin intervention 2: Metformin XR intervention 3: Metformin XR intervention 4: dapagliflozin matching Placebo intervention 5: metformin HCl Modified Release matching Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, once daily, 24 weeks intervention 2: Tablets, Oral, up to 2000 mg, once daily, 24 weeks intervention 3: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks intervention 4: Tablets intervention 5: Tablets

Protocol documents:
Clinical trial NCT00924781
Conditions: Anemia Chronic Kidney Disease
Keywords: Anemia associated with chronic kidney disease (CKD) Hemodialysis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-06-01; Completion date: 2010-05-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating agents.

Detailed description:
This study consists of a 12-week base study (MK2578-003-AM03) and an optional 40-week extension study (MK2578-003-EXT12). Participants who complete 12 weeks of treatment in the base study will enter the extension on the most recent dose administered in the base study or a newly adjusted dose, if adjustment is required to bring Hg levels within range. Participants' doses of MK2578 will be adjusted upward or downward during the extension study to maintain Hb in the range of 10-12 g/dL.

Arms: arm 1: Participants were randomized to receive treatment every week (QW). arm 2: Participants were randomized to receive treatment QM. arm 3: Participants were randomized to receive treatment QW. arm 4: Participants were randomized to receive treatment QM. arm 5: Participants were randomized to receive treatment QW. arm 6: Participants were randomized to receive treatment QM.
Interventions: intervention 1: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline intervention 2: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline intervention 3: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
Intervention descriptions: intervention 1: MK2578 was to be administered intravenously (IV). Participants in Cohort 1 were to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to every week (QW) or once every 4 weeks (QM) dosing schedules within each cohort. intervention 2: MK2578 was to be administered IV. Participants in Cohort 2 were to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort. intervention 3: MK2578 was to be administered IV. Participants in Cohort 3 were to receive 1 mcg of MK2578 for every 200 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.

Protocol documents:
Clinical trial NCT00968617
Conditions: Anemia Chronic Kidney Disease
Keywords: Anemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-11-01; Completion date: 2010-05-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will define an effective starting dose for subcutaneous administration of MK2578 to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic kidney disease (CKD) who are not on dialysis while evaluating its safety.

Detailed description:

Arms: arm 1: MK2578 arm 2: MK2578 arm 3: MK2578 arm 4: darbepoetin alfa
Interventions: intervention 1: MK2578 intervention 2: MK2578 intervention 3: MK2578 intervention 4: Comparator: darbepoetin alfa
Intervention descriptions: intervention 1: MK2578 1.0 mcg/kg/month intervention 2: MK2578 2.0 mcg/kg/month intervention 3: MK2578 3.6 mcg/kg/month intervention 4: darbepoetin alfa

Protocol documents:
Clinical trial NCT00978627
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2009-08-01; Completion date: 2010-05-01
Enrollment: 548 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin detemir intervention 3: insulin aspart intervention 4: insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted. intervention 3: Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted. intervention 4: Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT00017563
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer
Sponsor: OHSU Knight Cancer Institute
Start date: 2000-09-01; Completion date: 2010-05-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer.

Detailed description:
OBJECTIVES:

* Determine the 5-year freedom from prostate-specific antigen (PSA) recurrence in patients treated with this regimen.
* Define the maximum tolerated dose of neoadjuvant docetaxel and mitoxantrone followed by prostatectomy in patients with high-risk localized prostate cancer. (Phase I completed as of 2/15/02)
* Determine the toxicity of this regimen in these patients.
* Determine the PSA response rate and pathologic response rate in patients treated with this regimen.
* Determine the clinical response in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the surgical margin status at time of prostatectomy in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of mitoxantrone. (Phase I completed as of 2/15/02)

Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3. Treatment repeats once a week for a total of 4 courses.

Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is determined. (Phase I completed as of 2/15/02)

Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Arms: arm 1: Drug: Docetaxel-35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Drug: Mitoxantrone-Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Procedure/Surgery: Conventional Surgery- Prostatectomy will be scheduled 2-4 weeks after the last dose of chemotherapy
Interventions: intervention 1: docetaxel intervention 2: mitoxantrone hydrochloride intervention 3: conventional surgery
Intervention descriptions: intervention 1: 35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. intervention 2: Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks. intervention 3: Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.

Protocol documents:
Clinical trial NCT00084864
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2002-09-01; Completion date: 2010-05-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells.

PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma (cancer) of the prostate.

Detailed description:
OBJECTIVES:

* Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate.
* Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients.
* Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.
* Determine the acute effects of this regimen on serum PSA in these patients.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a two-stage, randomized, pilot study.

* Stage 1: Patients are randomized to 1 of 2 treatment arms.

  * Arm I: Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery. Within 48 hours of the last dose, patients undergo radical prostatectomy.
  * Arm II: Patients receive no study drugs, but undergo radical prostatectomy.
* Stage 2: If sufficient activity is seen with the dexamethasone and calcitriol regimen in stage 1, the study is expanded and additional patients are randomized to 1 of 4 treatment arms.

  * Arm I: Patients receive dexamethasone and calcitriol as in stage 1, arm I.
  * Arm II: Patients receive oral dexamethasone once daily on days 1-4.
  * Arm III: Patients receive oral calcitriol once daily on days 2-4.
  * Arm IV: Patients undergo radical prostatectomy as in stage 1, arm II. In arms I, II, and III, patients undergo radical prostatectomy as in stage 1, arm I.

Patients are followed at 1, 3, and 12 months.

PROJECTED ACCRUAL: A total of 20-80 patients (20 for stage 1 \[10 per treatment arm\] and 60 for stage 2) will be accrued for this study within 2 years.

Arms: arm 1: Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery. arm 2: No study drugs before surgery. arm 3: Patients receive oral dexamethasone once daily on days 1-4. arm 4: Patients receive oral calcitriol once daily on days 2-4.
Interventions: intervention 1: calcitriol intervention 2: dexamethasone intervention 3: clinical observation
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: No intervention before surgery

Protocol documents:
Clinical trial NCT00112671
Conditions: Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Bladder Cancer Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Regional Transitional Cell Cancer of the Renal Pelvis and Ureter Stage III Bladder Cancer Stage IV Bladder Cancer Transitional Cell Carcinoma of the Bladder
Sponsor: National Cancer Institute (NCI)
Start date: 2005-04-01; Completion date: 2010-05-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sorafenib works in treating patients with advanced or metastatic cancer of the urinary tract. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the efficacy (response rate and stable disease rate) of Bay 439006 given to patients with advanced or metastatic urothelial cancer.

II. To assess the toxicity, time to progression and response duration of Bay 439006 given to patients with advanced or metastatic urothelial cancer.

III. To measure Ras mutational status and EGFR/HER2 on archival specimens. To determine baseline and post-treatment levels of pERK, pAKT, VEGFR2, CD31, Ki-67/MIB-1, and cleaved caspase 3 and to explore the relationship between these correlative endpoints and clinical outcome.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

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

After completion of study treatment, patients are followed within 3 weeks and then every 3 months thereafter.

Arms: arm 1: Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sorafenib tosylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally 400mg orally twice daily intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00130520
Conditions: Ovarian Neoplasms
Keywords: advanced ovarian cancer refractory ovarian cancer primary peritoneal cancer
Sponsor: University of Arizona
Start date: 2005-06-01; Completion date: 2010-05-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).

Detailed description:
Erlotinib and bevacizumab, novel biologics, offer a new regimen for the treatment of ovarian cancer in women who are refractory to standard drug regimens. Because bevacizumab is an anti-angiogenesis drug and erlotinib is an EGFR receptor inhibitor their combination would lead to the inhibition of multiple signal transduction pathways and the reversal of cancer progression in this difficult to treat population. The study seeks to determine the efficacy and safety of the EGFR receptor inhibitor, erlotinib plus the anti-angiogenesis VEGF ligand inhibitor bevacizumab in women with platinum and taxane refractory ovarian cancer.

The study design is a non-randomized, open label, single center Phase II trial using a Simon two stage design. Eligible patients are women who have a histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary or primary peritoneal carcinoma who have relapsed or are refractory to therapy after primary treatment of their disease.

Patients will be treated with erlotinib 150 mg/day orally and bevacizumab 10mg/kg every two weeks plus or minus one day intravenously. Forty patients will be enrolled in the study. Initially 20 eligible patients will be accrued. If one or no confirmed response is observed, the trial will be closed and the agents considered inactive. Otherwise, 20 additional eligible patients will be accrued for a total of 40 patients. Eight or more responses out of 40 will be considered evidence warranting further study of the agents provided other factors, such as progression-free and overall survival, also appear favorable.

Previous studies of this combination in non-small cell lung cancer, renal cell carcinoma and metastatic breast cancer have indicated a potential synergistic effect for these two agents. Preliminary data for the use of bevacizumab in advanced ovarian cancer indicates that this agent has single-agent activity. As a result, the researchers are interested in exploring the role of the combination of erlotinib and bevacizumab in advanced ovarian cancer.

Arms: arm 1: None
Interventions: intervention 1: bevacizumab intervention 2: erlotinib
Intervention descriptions: intervention 1: 10mg/kg every two weeks IV-bevacizumab intervention 2: 150mg daily by mouth-erlotinib

Protocol documents:
Clinical trial NCT00149734
Conditions: Schizophrenia
Keywords: Schizophrenia Ondansetron P50 sensory gating Evoked potentials 5-HT3 receptors Atypical antipsychotics
Sponsor: University of Colorado, Denver
Start date: 2005-01-01; Completion date: 2010-05-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics.

Detailed description:
Schizophrenia is a devastating brain disorder. Most people with schizophrenia have difficulty filtering out unimportant auditory information. They have an inability to appropriately inhibit, or gate, sensory information that enters the ear. Standard treatments do not address this problem. When the drug ondansetron is taken in addition to typical antipsychotic drugs, P50 auditory gating improves. However, ondansetron has not been used with some of the newer, atypical antipsychotic drugs. This study will evaluate the effect of combining ondansetron with newer, atypical antipsychotic drugs on P50 auditory gating.

Participants in this double-blind study will be randomly assigned to receive either ondansetron or placebo for 3 months. Upon completion of the first 3 months, participants will be crossed over to receive the other treatment for an additional 3 months. All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole. Auditory gating will be assessed using computerized cognitive testing and functional magnetic resonance imaging (fMRI) at baseline and Months 3 and 6. Vital signs and evoked potentials will be assessed at Weeks 1, 3, and 6. Clinical symptoms and cognitive abilities will also be evaluated to determine the effectiveness of ondansetron.

Arms: arm 1: Participants will take ondansetron then placebo plus an atypical antipsychotic drug arm 2: Participants will take placebo then ondansetron plus an atypical antipsychotic drug
Interventions: intervention 1: Ondansetron followed by placebo intervention 2: Placebo followed by Ondansetron
Intervention descriptions: intervention 1: Participants will take 16mg of ondansetron daily for the first three months followed by 3 months of placebo. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period. intervention 2: Participants will take placebo daily for the first three months followed by 3 months of 16mg of ondansetron daily. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.

Protocol documents: