ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00959946
Conditions: Advanced Breast Cancer (Parts 1 and 2) Advanced Pancreatic Cancer (Part 1) Advanced Colorectal Cancer (Part 1) Advanced Cholangiocarcinoma (Part 1) Advanced Glioblastoma Multiforme (Part 1)
Keywords: Phase 1/2 2-part study bosutinib and capecitabine
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2011-03-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a research study in 2 parts assessing the following parameters of the combination of the study drug called bosutinib, and a drug called capecitabine: the safety, how well the subject's body handles the study drug, and preliminary anti-tumor activity as treatment for different types of cancers in part 1, and breast cancer only in part 2.

In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels of each drug in order to determine the highest tolerated dose of the combination study treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest tolerated dose to see how well the study treatment works to treat breast cancer. In addition, genetic research testing (research analyses involving genes and gene products) will be performed on biological samples from subjects.

Detailed description:
The study was prematurely discontinued following Part 1 evaluation, when the sponsor concluded that further translational biomarker analyses were needed to better define the breast tumor biomarkers that predict sensitivity to Src family kinase inhibitors. Thus the Sponsor made a determination to stop the study after Part 1 as communicated to investigators on 02Dec2010 . No subjects were enrolled into Part 2 of this study. The study was not terminated due to safety reasons.

Arms: arm 1: In part 1 (phase 1), ascending and descending multiple oral doses of bosutinib + capecitabine. Doses in part 1 include capecitabine 750 mg/m2 BID on days 1-14 + bosutinib 200 mg QD; capecitabine 625 mg/m2 BID on days 1-14 + bosutinib 300 mg QD. Depending on safety, capecitabine can also be administered at 1000 mg/m2 BID and bosutinib can be administered at 200 mg/m2 QD. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2).
Interventions: intervention 1: Bosutinib intervention 2: Capecitabine
Intervention descriptions: intervention 1: Doses in part 1 include bosutinib 200 mg QD; bosutinib 300 mg QD. Depending on safety bosutinib can be administered at 200 mg/m2 QD. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2). intervention 2: Doses in part 1 include capecitabine 750 mg/m2 BID on days 1-14; capecitabine 625 mg/m2 BID on days 1-14. Depending on safety, capecitabine can also be administered at 1000 mg/m2 BID. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2).

Protocol documents:
Clinical trial NCT00960440
Conditions: Arthritis, Rheumatoid
Keywords: randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy
Sponsor: Pfizer
Start date: 2009-10-01; Completion date: 2011-03-01
Enrollment: 399 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: CP-690,550 intervention 5: Placebo intervention 6: CP-690,550
Intervention descriptions: intervention 1: Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period. intervention 2: Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period. intervention 3: Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period. intervention 4: Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period. intervention 5: Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period. intervention 6: Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.

Protocol documents:
Clinical trial NCT00961571
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal cancer sunitinib capecitabine
Sponsor: Georgetown University
Start date: 2009-08-01; Completion date: 2011-03-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer.

All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until their cancer gets worse.

Detailed description:
This is a single-center, open-label, one-arm study. Patients will be stratified by prior adjuvant therapy and ECOG performance status at study entry.

In this study, we propose to obtain PET scans at baseline, 2 weeks, 8 weeks and 24 weeks from the initiation of treatment. Response at 2 weeks, 8 weeks and 24 weeks will be correlated to progression-free survival, overall survival and response according to RECIST criteria.

We will collect plasma and urine samples from enrolled patients before and four weeks after sunitinib treatment. The samples will be analyzed and results correlated with patient clinical outcomes in order to explore the underlying mechanism of sunitinib induced hypertension.

Arms: arm 1: Administration of sunitinib and capecitabine
Interventions: intervention 1: sunitinib and capecitabine
Intervention descriptions: intervention 1: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily

Protocol documents:
Clinical trial NCT00971932
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Recurrent and/or metastatic SCCHN
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-07-01; Completion date: 2011-03-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cetuximab intervention 2: Cisplatin/Carboplatin intervention 3: 5-Fluorouracil
Intervention descriptions: intervention 1: The initial dose of cetuximab will be 400 milligram per square meter (mg/m\^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m\^2 as an IV infusion over 60 minutes. intervention 2: Subjects will receive 100 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. If subject developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) will be administered as an IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle. intervention 3: Subjects will receive 1000 mg/m\^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle.

Protocol documents:
Clinical trial NCT00974090
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-09-01; Completion date: 2011-03-01
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea) intervention 2: Teneli / Teneli + SU
Intervention descriptions: intervention 1: Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea intervention 2: Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea

Protocol documents:
Clinical trial NCT00974974
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Sponsor: Impax Laboratories, LLC
Start date: 2009-09-01; Completion date: 2011-03-01
Enrollment: 471 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

Detailed description:
A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.

Arms: arm 1: Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066. arm 2: Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
Interventions: intervention 1: IPX066 intervention 2: IR CD-LD
Intervention descriptions: intervention 1: extended-release carbidopa-levodopa capsules intervention 2: immediate-release carbidopa-levodopa tablets

Protocol documents:
Clinical trial NCT00976937
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2009-08-01; Completion date: 2011-03-01
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index \[BMI\] greater than or equal to 30 kilogram per square meter \[kg/m\^2\]) type 2 diabetic patients less than 50 years of age, over a period of 24 weeks of treatment.

The primary objective of this study is to assess the efficacy of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24.

Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.

Detailed description:

Arms: arm 1: 2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24. arm 2: Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Lixisenatide Placebo intervention 3: Pen auto-injector intervention 4: Sitagliptin intervention 5: Sitagliptin Placebo intervention 6: Metformin
Intervention descriptions: intervention 1: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Administered orally once a day in the morning with or without food at approximately the same time each day. intervention 5: Administered orally once a day in the morning with or without food at approximately the same time each day. intervention 6: Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

Protocol documents:
Clinical trial NCT00985985
Conditions: Smoking
Keywords: smoking cessation nicotine lozenge nicotine replacement therapy
Sponsor: GlaxoSmithKline
Start date: 2009-05-01; Completion date: 2011-03-01
Enrollment: 723 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult cigarette smokers who are motivated to quit smoking. Successful quitters or participants who smoke occasionally will be followed up after week 24 till 12 months.

Detailed description:

Arms: arm 1: 2 mg nicotine lozenge arm 2: 2 mg placebo arm 3: 4 mg nicotine lozenge arm 4: 4 mg placebo
Interventions: intervention 1: Nicotine intervention 2: Placebo
Intervention descriptions: intervention 1: 2 mg or 4 mg nicotine lozenge intervention 2: placebo lozenge

Protocol documents:
Clinical trial NCT00986921
Conditions: Abortion
Keywords: Length of time for procedure to be completed Need for additional dilation Subject satisfaction with procedure
Sponsor: Boston University
Start date: 2009-10-01; Completion date: 2011-03-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

Detailed description:

Arms: arm 1: women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed. arm 2: Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure
Interventions: intervention 1: mifepristone 200 mg intervention 2: osmotic dilator insertion
Intervention descriptions: intervention 1: mifepristone would be given the day before the procedure intervention 2: osmotic dilators (3-6) would be inserted as usual the day before the procedure

Protocol documents:
Clinical trial NCT00993473
Conditions: Type 1 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2009-10-01; Completion date: 2011-03-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin.

Secondary objectives were to compare insulin glargine and NPH in terms of:

* rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia
* HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment
* percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment
* average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability

Detailed description:
Screening phase: 2 to 4 weeks

Treatment phase: 24 weeks

At randomization, patients were stratified with respect to their baseline HbA1c level (\<8.5% or ≥8.5%) and hypoglycemic event rate (number of CGMS hypoglycemic excursions \<0.5 or ≥0.5 events per 24 hours). Following randomization, trial basal insulin was initiated and up-titrated within the first 12 weeks to reach a stable dose.

Follow-up phase: 2 weeks

All Phases: 28 to 30 weeks

Arms: arm 1: Lantus given as basal insulin once a day in the morning by subcutaneous injection arm 2: Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day generally in the morning and /or at bedtime by subcutaneous injection
Interventions: intervention 1: Insulin glargine (HOE901) intervention 2: Neutral Protamine Hagedorn (NPH) insulin intervention 3: Insulin lispro
Intervention descriptions: intervention 1: 100 U/mL commercial solution for injection available as both disposable pen devices Solostar® each containing 300 U and as 10 mL vials each containing 1000 U

Dose: titrated to achieve the following glycemic targets without hypoglycemia:

* Fasting blood glucose (BG) between 90 and 145 mg/dL (5.0 to 8.0 mmol/L), inclusive,
* Bedtime BG between 120 and 180 mg/dL (6.7 to10.0 mmol/L), inclusive,
* Nocturnal BG between 80 and 162 mg/dL (4.4 to 9.0 mmol/L), inclusive; and
* HbA1c \<7.5%. intervention 2: NPH insulin 100 U/mL commercial (Huminsulin Basal) solution for injection available as both disposable pen devices (Huminsulin Basal Pen) each containing 300 U and as 10 mL vials each containing 1000 U

Dose: titrated to achieve glycemic targets as described above for insulin glargine intervention 3: Insulin lispro used as the principal bolus insulin; regular human insulin permitted. Administration: multiple injection before meals and/or at bedtime at the discretion of the Investigator.

Protocol documents:
Clinical trial NCT00994890
Conditions: Osteoarthritis, Knee Osteoarthritis, Hip
Keywords: Double-blind safety
Sponsor: Pfizer
Start date: 2009-11-17; Completion date: 2011-03-01
Enrollment: 679 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.

Detailed description:
Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tanezumab 2.5 mg intervention 2: Tanezumab 5 mg intervention 3: Tanezumab 10 mg
Intervention descriptions: intervention 1: Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year intervention 2: Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year intervention 3: Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year

Protocol documents:
Clinical trial NCT00996372
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2009-10-01; Completion date: 2011-03-01
Enrollment: 949 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

Detailed description:

Arms: arm 1: flibanserin 100mg po qd arm 2: placebo one tablet po qd
Interventions: intervention 1: flibanserin intervention 2: placebo
Intervention descriptions: intervention 1: patients will be randomized to flibanserin or placebo in a double-blind manner intervention 2: patients will be randomized to flibanserin or placebo in a double-blind manner

Protocol documents:
Clinical trial NCT01004185
Conditions: Ulcerative Colitis
Sponsor: Warner Chilcott
Start date: 2009-10-01; Completion date: 2011-03-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.

Detailed description:

Arms: arm 1: 2.0 - 4.8 g/day Asacol dependent on body weight arm 2: 1.2 - 2.4 g/day Asacol dependent upon body weight
Interventions: intervention 1: Asacol 400 mg intervention 2: Asacol 400 mg
Intervention descriptions: intervention 1: 17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-\<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-\<90kg = 6 Asacol 400mg AM \& PM intervention 2: 17-\<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-\<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo PM; 54-\<90kg = 3 Asacol 400mg \& 3 placebo AM \& PM

Protocol documents:
Clinical trial NCT01004705
Conditions: Elevated LDL Cholesterol
Keywords: cardiovascular fixed dose combination pill LDL cholesterol
Sponsor: Ferrer Internacional S.A.
Start date: 2009-09-01; Completion date: 2011-03-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.

Detailed description:

Arms: arm 1: Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg ramipril) arm 2: Once daily oral dose of Simvastatin 40 mg
Interventions: intervention 1: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), intervention 2: Simvastatin
Intervention descriptions: intervention 1: A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks. intervention 2: A once daily oral dose of simvastatin for 12 weeks.

Protocol documents: