ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00544882
Conditions: Healthy
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2007-10-31; Completion date: 2008-03-31
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.

Detailed description:
Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior to beginning the Cycle 1 baseline cycle. After completing screening, all enrolled participants continued to receive the same regimen of 150 μg DSG /20 μg EE combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1 (the Run-In phase). Following completion of Cycle 1, participants were randomly assigned to receive either DR-1021 or Mircette during Cycle 2. All participants who completed Cycle 2 were to receive Kariva during Cycle 3; however, participants were only followed for the first 21 days of this 28-day regimen, after which they were considered study completers.

Arms: arm 1: After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). arm 2: After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
Interventions: intervention 1: DR-1021 intervention 2: Mircette® intervention 3: Kariva®
Intervention descriptions: intervention 1: Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets. intervention 2: Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets. intervention 3: Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Protocol documents:
Clinical trial NCT00838383
Conditions: Cardiac Surgery Subjects Subjects Undergoing CABG and/or Cardiac Valve Replacement
Keywords: multi-center placebo-controlled randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB
Sponsor: Pfizer
Start date: 2006-08-10; Completion date: 2008-03-31
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: sitaxsentan (Thelin) intervention 2: sitaxsentan (Thelin) intervention 3: Placebo
Intervention descriptions: intervention 1: sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. intervention 2: Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. intervention 3: Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.

Protocol documents:
Clinical trial NCT00101660
Conditions: Chronic Myeloid Leukemia Philadelphia-Positive Myeloid Leukemia
Keywords: Chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph+CML)
Sponsor: Bristol-Myers Squibb
Start date: 2005-02-01; Completion date: 2008-04-01
Enrollment: 387 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.

Detailed description:

Arms: arm 1: Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Tablets; oral; 70 mg BID, depending on response

Protocol documents:
Clinical trial NCT00101907
Conditions: Lung Cancer Pancreatic Cancer Esophageal Cancer
Keywords: Advanced Cancer AMG 706 Panitumumab Gemcitabine-Cisplatin
Sponsor: Amgen
Start date: 2004-12-01; Completion date: 2008-04-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.

Detailed description:

Arms: arm 1: Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle. arm 2: AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle. arm 3: AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle. arm 4: AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle. arm 5: AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle. arm 6: AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.
Interventions: intervention 1: AMG 706 intervention 2: Panitumumab intervention 3: Gemcitabine intervention 4: Cisplatin
Intervention descriptions: intervention 1: AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1. intervention 2: Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle. intervention 3: Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2. intervention 4: Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

Protocol documents:
Clinical trial NCT00109772
Conditions: Complex Regional Pain Syndrome, Type I
Keywords: CRPS RSDS Pain CC-5013 Revlimid Complex Regional Pain Syndrome Reflex Sympathy Dystrophy Syndrome Lenalidomide CRPS Type I Celgene
Sponsor: Celgene Corporation
Start date: 2005-02-01; Completion date: 2008-04-01
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.

Detailed description:
This is a multicenter, double-blind, placebo-controlled study in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.

One hundred eighty (180) subjects diagnosed with unilateral CRPS Type 1 will be enrolled and randomized to receive orally either 10 mg/day of lenalidomide or placebo (90 subjects per treatment arm). For each subject, the study consists of three phases: Pre-randomization Phase (2 weeks), Treatment Phase (12 weeks) and Extension Phase where subjects have the opportunity to receive lenalidomide treatment as long as a benefit is derived from the drug. Subjects who complete all 12 weeks of the treatment phase may be eligible to receive lenalidomide in the extension phase. Subject may continue in the extension phase as long as a benefit is derived from the drug.

Arms: arm 1: 10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure. arm 2: Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Interventions: intervention 1: lenalidomide intervention 2: Placebo
Intervention descriptions: intervention 1: Two 5 mg capsules taken one time per day intervention 2: Two placebo capsules taken one time per day

Protocol documents:
Clinical trial NCT00252720
Conditions: Type 1 Diabetes
Keywords: Diabetes mellitus type 1
Sponsor: AstraZeneca
Start date: 2001-08-01; Completion date: 2008-04-01
Enrollment: 1850 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.

Detailed description:

Arms: arm 1: candesartan cilexetil 32 mg once daily arm 2: control
Interventions: intervention 1: candesartan
Intervention descriptions: intervention 1: 32 mg oral tablet

Protocol documents:
Clinical trial NCT00252733
Conditions: Type 1 Diabetes
Keywords: Diabetes Mellitus, Insulin-Dependent
Sponsor: AstraZeneca
Start date: 2001-06-01; Completion date: 2008-04-01
Enrollment: 5238 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, beneficially influences the rate of change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including secondary prevention studies of diabetic retinopathy in both type 1 and type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.

Detailed description:

Arms: arm 1: Placebo arm 2: candesartan cilexetil
Interventions: intervention 1: candesartan cilexetil
Intervention descriptions: intervention 1: 32 mg once daily oral tablet given over 60 months

Protocol documents:
Clinical trial NCT00261495
Conditions: Pain
Keywords: chronic noncancer pain pain analgesia analgesic opioid oxycodone hydromorphone
Sponsor: Janssen Pharmaceutica N.V., Belgium
Start date: 2006-03-01; Completion date: 2008-04-01
Enrollment: 504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).

Detailed description:
Conventional immediate-release forms of hydromorphone and oxycodone have a relatively short duration of action that require dosing every 4 to 6 hours. To counterbalance the drawback of repeated opioid intake, sustained-release formulations of oxycodone and hydromorphone were developed that allow twice-daily dosing. Subsequently, a novel, once-daily, extended-release hydromorphone formulation was developed to further enhance ease of treatment and improve effectiveness in the treatment of severe pain. This is a randomized, open-label, comparative, parallel-group, 24-week flexible-dose study in patients with chronic noncancer pain severe enough to require continuous opioid therapy. Patients will receive either 8 mg of sustained-release hydromorphone, taken once daily or 10 mg of controlled-release oxycodone, taken twice daily. Individual adjustments in dosing will be performed to achieve satisfactory pain control, up to a maximum daily dosage of 32 mg for hydromorphone and 80 mg for oxycodone. The primary efficacy outcome will be the determination of the dose of hydromorphone that produces a level of pain control that is equal to the pain control provided by oxycodone (equi-analgesic dose). Safety will be monitored throughout the study. The study hypothesis is that sustained-release hydromorphone taken once daily is well tolerated and is not inferior with regard to pain control to controlled-release oxycodone taken twice daily.

Amendment:

Amendment was made to the duration of the study from duration of '24 weeks' to '52 weeks' in order to collect long-term safety and efficacy data. OROS hydromorphone 8, 16, or 32 mg tablets QD or SR oxycodone 10, 20, or 40 mg tablets BID. Individual adjustments in dosing performed to achieve satisfactory pain control over 24 weeks. Amendment: treatment duration was extended to 52 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: OROS hydromorphone HCl intervention 2: Oxycodone
Intervention descriptions: intervention 1: 8 to 32 mg once daily for 52 weeks (flexible dosing) intervention 2: 10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)

Protocol documents:
Clinical trial NCT00400179
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Sponsor: Taiho Oncology, Inc.
Start date: 2005-05-01; Completion date: 2008-04-01
Enrollment: 1053 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm). Patients will be stratified by number of metastatic sites (one vs. more than one), locally advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or non-measurable disease, and center.

Detailed description:

Arms: arm 1: In Arm A, S-1 25 mg/m² was administered orally BID from Day 1 through Day 21 followed by a recovery period from Days 22 through Day 28. On Day 1, the morning dose of S-1 was administered before cisplatin 75 mg/m2 administration as a 1- to 3-hour IV infusion. This regimen was repeated every 4 weeks. S-1 was administered one hour before or one hour after a meal with a glass of water (approximately 100 mL). arm 2: In Arm B, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion (CIV) over 120 hours (on Days 1 through 5). This regimen was repeated every 4 weeks. 5-FU CIV followed cisplatin infusion on Day 1. All 5-FU used in this study was commercially available product.
Interventions: intervention 1: S-1/Cisplatin intervention 2: 5-FU/cisplatin
Intervention descriptions: intervention 1: In Arm A, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth (NPO 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with approximately 8 ounces of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour IV infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin. intervention 2: In Arm B, 5-FU 1000 mg/m2/24 hours was administered CIV on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin.

Protocol documents:
Clinical trial NCT00026494
Conditions: Metastatic Cancer
Keywords: tumors metastatic to brain
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2001-07-01; Completion date: 2008-04-01
Enrollment: 49 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.

PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases.

Detailed description:
OBJECTIVES:

* Determine the maximum tolerated dose of vinorelbine when administered in combination with temozolomide in patients with recurrent brain metastases (phase I accrual completed).
* Determine the safety and feasibility of this treatment regimen in these patients.
* Determine the efficacy of this treatment regimen, in terms of objective radiographic response and overall and progression-free survival, in these patients.

OUTLINE: This is a dose-escalation study of vinorelbine.

Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and oral temozolomide once daily on days 1-7 and 15-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-35 patients will be treated at that dose level.

Patients are followed every 3-4 months.

PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion of this study and 20-35 patients will be accrued for the phase II portion of this study within 2 years.

Arms: arm 1: Patients will be treated with vinorelbine on days 1 and 8 of each cycle; temozolomide will be administered on days 1 to 7 and 15 to 21 of each cycle. The dose level of temozolomide will be given at a dose of 150 mg/m2/day. A cycle will be defined as 28 days of treatment.
Interventions: intervention 1: temozolomide intervention 2: vinorelbine tartrate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00084487
Conditions: Extensive Stage Small Cell Lung Cancer Limited Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-04-01; Completion date: 2008-04-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.

Detailed description:
OBJECTIVES:

I. Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy.

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

III. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15 months.

Arms: arm 1: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: becatecarin
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00094107
Conditions: Melanoma Skin Neoplasms
Keywords: melanoma antiangiogenesis
Sponsor: Pfizer
Start date: 2004-12-01; Completion date: 2008-04-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2 study being conducted at multiple centers in the United States and France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Axitinib [AG-013736]
Intervention descriptions: intervention 1: VEGFR \[vascular endothelial growth factor Receptor\] and PDGFR \[Platelet-Derived Growth Factor Receptor\] inhibitor: Single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.

Protocol documents:
Clinical trial NCT00096785
Conditions: Hepatitis B Chronic Disease
Keywords: chronic hepatitis B infection
Sponsor: Bristol-Myers Squibb
Start date: 2004-12-01; Completion date: 2008-04-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: entecavir intervention 2: adefovir
Intervention descriptions: intervention 1: Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks intervention 2: Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks

Protocol documents: