ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00327015
Conditions: Diabetes
Sponsor: AstraZeneca
Start date: 2006-05-01; Completion date: 2008-12-01
Enrollment: 1306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

Detailed description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication

Arms: arm 1: PLUS open-label pioglitazone (as needed as rescue medication) arm 2: PLUS open-label pioglitazone (as needed as rescue medication) arm 3: PLUS open-label pioglitazone (as needed as rescue medication) arm 4: PLUS open-label pioglitazone (as needed as rescue medication)
Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Metformin intervention 4: Placebo intervention 5: pioglitazone
Intervention descriptions: intervention 1: Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) intervention 2: Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT) intervention 3: Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) intervention 4: Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) intervention 5: Tablets, Oral, 15-45 mg, as needed (12 months LT)

Protocol documents:
Clinical trial NCT00361842
Conditions: Colorectal Neoplasms
Keywords: Colorectal cancer Colorectal carcinoma Colonic cancer Rectal cancer
Sponsor: Jazz Pharmaceuticals
Start date: 2006-07-01; Completion date: 2008-12-01
Enrollment: 65 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks.

Detailed description:
CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. The two drugs are present inside the liposome in a fixed 1:1 molar ratio. CPX-1 was developed as a means of delivering and preserving a fixed 1:1 molar ratio of the two drugs. This ratio was found in vitro and in vivo models of cancer to have synergistic anti-cancer activity and preservation and delivery of this ratio is important because other ratios of these two drugs have been found to be antagonistic or only additive. Both floxuridine and irinotecan HCl are active chemotherapeutic agents, each approved for clinical use in the United States and Canada for colorectal cancer. Current practice routinely administers 5- fluorouracil with irinotecan in combination regimens in first or second line treatment without the means of preserving the synergistic ratio.

Arms: arm 1: None
Interventions: intervention 1: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
Intervention descriptions: intervention 1: CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.

Protocol documents:
Clinical trial NCT00463866
Conditions: Asthma
Keywords: Asthma
Sponsor: AstraZeneca
Start date: 2007-03-01; Completion date: 2008-12-01
Enrollment: 8424 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Detailed description:

Interventions: intervention 1: Budesonide/formoterol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00473889
Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin

Detailed description:

Arms: arm 1: vorinostat; IV paclitaxel; IV carboplatin arm 2: Placebo; IV paclitaxel; IV carboplatin
Interventions: intervention 1: vorinostat intervention 2: Comparator: paclitaxel intervention 3: Comparator: carboplatin intervention 4: Comparator: placebo
Intervention descriptions: intervention 1: vorinostat 400 mg capsules once daily. Up to 6 months of treatment intervention 2: intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment intervention 3: intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment. intervention 4: vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

Protocol documents:
Clinical trial NCT00483548
Conditions: Bipolar Disorder Depression, Bipolar
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-10-01; Completion date: 2008-12-01
Enrollment: 298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.

Detailed description:

Arms: arm 1: Active treatment, double-blind, randomized treatment arm arm 2: Inactive, placebo treatment, double-blind, randomized arm
Interventions: intervention 1: Ziprasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day. intervention 2: Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm

Protocol documents:
Clinical trial NCT00501969
Conditions: Advanced Stage Parkinson's Disease
Keywords: Rotigotine Neupro®
Sponsor: UCB Pharma
Start date: 2004-08-01; Completion date: 2008-12-01
Enrollment: 395 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

Detailed description:
This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa

Arms: arm 1: Rotigotine
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine trans-dermal patches once daily:

20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)

Protocol documents:
Clinical trial NCT00503698
Conditions: Chronic Kidney Disease End-Stage Renal Disease
Sponsor: Novo Nordisk A/S
Start date: 2007-07-01; Completion date: 2008-12-01
Enrollment: 712 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.

The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.

Detailed description:
The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.

Arms: arm 1: Somatropin once daily from week 0 to end of trial arm 2: Placebo once daily to end of trial
Interventions: intervention 1: somatropin intervention 2: placebo
Intervention descriptions: intervention 1: 20 mcg/kg/day, injected s.c. (under the skin) intervention 2: Placebo injected s.c (under the skin)

Protocol documents:
Clinical trial NCT00504881
Conditions: Epilepsy
Keywords: Epilepsy Brivaracetam Partial Onset Seizures
Sponsor: UCB Pharma SA
Start date: 2007-10-01; Completion date: 2008-12-01
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.

Detailed description:

Arms: arm 1: Matching Placebo tablets administered twice a day arm 2: A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Interventions: intervention 1: Placebo intervention 2: Brivaracetam
Intervention descriptions: intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period

Protocol documents:
Clinical trial NCT00594386
Conditions: Parkinson's Disease
Keywords: Rotigotine Neupro
Sponsor: UCB Pharma
Start date: 2002-08-01; Completion date: 2008-12-01
Enrollment: 258 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease.

Detailed description:
This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.

Arms: arm 1: None
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine transdermal patches:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours.

After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

Protocol documents:
Clinical trial NCT00672620
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Drug Therapy Major Depressive Episode
Sponsor: Takeda
Start date: 2008-04-01; Completion date: 2008-12-01
Enrollment: 611 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.

Detailed description:
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.

The study enrolled 611 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 2.5 mg
* Vortioxetine 5 mg
* Duloxetine 10 mg
* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 12 weeks. Participants made 8 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Arms: arm 1: Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. arm 3: Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsules, orally, once daily for 1 week after the treatment period. arm 4: Placebo-matching capsules, orally, once daily for up to 9 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Duloxetine intervention 3: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Duloxetine capsules intervention 3: Placebo-matching capsules

Protocol documents:
Clinical trial NCT00057681
Conditions: Bipolar Disorder
Keywords: Mania
Sponsor: Washington University School of Medicine
Start date: 2003-02-01; Completion date: 2008-12-01
Enrollment: 379 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.

Detailed description:
Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.

Arms: arm 1: Participants will receive treatment with lithium for 8 to 16 weeks arm 2: Participants will receive treatment with valproate for 8 to 16 weeks arm 3: Participants will receive treatment with risperidone for 8 to 16 weeks
Interventions: intervention 1: Lithium carbonate intervention 2: Valproate intervention 3: Risperidone
Intervention descriptions: intervention 1: Titrated until blood level is 1.1 to 1.3 mEq/L intervention 2: Titrated until blood level is 111 to 125 ug/mL intervention 3: Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID

Protocol documents:
Clinical trial NCT00065429
Conditions: Small Cell Lung Cancer
Sponsor: ImmunoGen, Inc.
Start date: 2003-04-01; Completion date: 2008-12-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors.

Detailed description:
The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and the MTD was determined by the Phase I portion of the trial (60mg/m2).

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II. arm 6: None arm 7: None
Interventions: intervention 1: BB-10901
Intervention descriptions: intervention 1: I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.

Protocol documents:
Clinical trial NCT00084617
Conditions: Adenocarcinoma of the Gastroesophageal Junction Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Mixed Adenocarcinoma of the Stomach Recurrent Gastric Cancer Stage IIIA Gastric Cancer Stage IIIB Gastric Cancer Stage IIIC Gastric Cancer Stage IV Gastric Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-03-01; Completion date: 2008-12-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the total response rate of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma.

II. To assess the duration of total responses of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 18 months.

Arms: arm 1: Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: oxaliplatin intervention 2: irinotecan hydrochloride intervention 3: capecitabine
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given orally

Protocol documents:
Clinical trial NCT00087152
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-06-01; Completion date: 2008-12-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with capecitabine works in treating women with progressive stage IV breast cancer.

Detailed description:
OBJECTIVES:

* Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine.
* Determine the 6-month progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Correlate, preliminarily, c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate\* once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: \*If the patient tolerates the starting dose of imatinib mesylate in course 1, the dose will be increased in subsequent courses.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-70 patients (25-45 patients with measurable disease and 25 with non-measurable disease) will be accrued for this study within 2 years.

Arms: arm 1: None
Interventions: intervention 1: Capecitabine intervention 2: Imatinib mesylate
Intervention descriptions: intervention 1: 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle intervention 2: 400 mg by mouth daily

Protocol documents:
Clinical trial NCT00091442
Conditions: Breast Cancer
Keywords: Breast Cancer Advanced breast cancer Breast Tumors Cancer of Breast Human Mammary Carcinoma Mammary Neoplasms, Human DOXIL Docetaxel
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2004-09-01; Completion date: 2008-12-01
Enrollment: 751 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.

Detailed description:
This is a randomized (the study medication is assigned by a random order), active control (study medication will be compared with available standard care of treatment), parallel-group (each treatment group will be treated simultaneously at the same time and each participant only receives one treatment regimen as assigned), open-label (both the investigator and the participant know the intervention received by the participant), multicenter study designed to determine if women with locally advanced or metastatic breast cancer, who were previously treated with prior anthracycline therapy in the neoadjuvant (administration of treatment before surgery) or adjuvant setting (administration of treatment after surgery), and who also had a disease-free interval of at least 12 months since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL to docetaxel therapy. Approximately 751 participants will be randomly assigned to either receive docetaxel monotherapy or DOXIL in combination with docetaxel therapy. Treatment is to continue until disease progression or the occurrence of unacceptable treatment related toxicity. Safety evaluations will include assessments of adverse events which will be recorded from the first study related procedure until 30 days after the last dose of medication; clinical laboratory tests and tests for cardiac function (multiple gated acquisition scan/echocardiogram and electrocardiogram) which will be monitored throughout the study.

Arms: arm 1: DOXIL and docetaxel combination therapy: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. arm 2: Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
Interventions: intervention 1: Docetaxel intervention 2: DOXIL
Intervention descriptions: intervention 1: Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle intervention 2: DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Protocol documents: