ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01868503
Conditions: Male Breast Cancer Recurrent Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer
Sponsor: Stanford University
Start date: 2013-07-01; Completion date: 2015-07-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well lapatinib ditosylate and radiation therapy work in treating patients with locally advanced or locally recurrent breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving lapatinib ditosylate together with radiation therapy may be an effective treatment for breast cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the clinical complete response rate (CR) after concurrent lapatinib (lapatinib ditosylate) and radiotherapy in patients with locally advanced or locally recurrent breast cancer that is refractory to chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the feasibility of assessing breast cancer stem cells (BCSCs) using flow cytometry and single cell gene expression profiling (SCGEP).

II. To determine the change in the proportion of BCSCs after combined modality therapy.

III. To evaluate the safety and efficacy of the combination of lapatinib and radiotherapy.

IV. To assess the pathologic complete response rate (pCR) in those undergoing surgical resection.

OUTLINE:

Patients receive lapatinib ditosylate orally (PO) once daily (QD) on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.

After completion of study treatment, patients are followed up at 2-4 weeks and then at 6-12 weeks.

Arms: arm 1: Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.
Interventions: intervention 1: lapatinib ditosylate intervention 2: radiation therapy intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Undergo radiation therapy intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01889420
Conditions: Multiple Myeloma in Relapse
Keywords: myeloma relapse refractory relapsed pomalidomide pomalyst everolimus afinitor dexamethasone
Sponsor: New Mexico Cancer Research Alliance
Start date: 2014-07-01; Completion date: 2015-07-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to test the possibility that a combination of three drugs, pomalidomide and everolimus with dexamethasone, may improve patient responses when compared with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.

Detailed description:
Given that pomalidomide is an FDA approved drug for patients with relapsed or progressive myeloma, and everolimus has been shown to have single agent activity in relapsed myeloma, it seems reasonable to combine these two active drugs in patients with relapsed/refractory disease. Given that low dose dexamethasone dramatically improved the response rate of pomalidomide, this drug will be added to the combination.

Arms: arm 1: Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle
Interventions: intervention 1: Combination therapy
Intervention descriptions: intervention 1: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.

Cycles will span 28 days. Dosage schedules will be:

1. Everolimus daily for 28 days of a 28 day cycle;
2. Pomalidomide daily for 21 days of a 28 day cycle
3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.

Protocol documents:
Clinical trial NCT01895946
Conditions: Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, Tumour Response,
Keywords: Advanced solid malignancy, AZD5363, food effect, formulation comparison
Sponsor: AstraZeneca
Start date: 2013-12-01; Completion date: 2015-07-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

Detailed description:
This study is designed to investigate the safety, tolerability and pharmacokinetics of a new drug, AZD5363, in patients with advanced cancer . This study will investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug), the comparison of a capsule and a tablet formulation and the effect of food on AZD5363 tablet formulation.

Arms: arm 1: AZD5363 tablet twice daily followed by AZD5363 capsule twice daily on an intermittent regimen (4 days on, 3 days off). arm 2: AZD5363 tablet twice daily on an intermittent regimen (4 days on, 3 days off) with/without food on one occasion
Interventions: intervention 1: AZD5363 intervention 2: AZD5363
Intervention descriptions: intervention 1: Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation. intervention 2: Oral AZD5363 twice daily, 4 days on 3 days off, tablet formulation. On day 4 AZD5363 tablet without food. On day 11 AZD5363 tablet with food.

Protocol documents:
Clinical trial NCT01896128
Conditions: Stroke Cerebrovascular Accident Hemiparesis
Keywords: stroke CVA cerebrovascular accident hemiparesis impairment motor recovery neuroplasticity nuvigil armodafinil
Sponsor: Burke Rehabilitation Hospital
Start date: 2008-01-01; Completion date: 2015-07-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-related training, armodafinil may accelerate motor recovery in chronic stroke patients.

The primary aim of this study is to determine whether administration of armodafinil during subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by armodafinil and, therefore, will induce an improvement in motor function and better performances on measures of motor control.

Detailed description:

Arms: arm 1: 150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days arm 2: inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: inactive pill manufactured to mimic Armodafinil 150 mg tablet

Protocol documents:
Clinical trial NCT01916109
Conditions: Bladder Cancer
Keywords: Gemcitabine Carboplatin Panitumumab (GCaP) radical cystectomy 10-103
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2013-08-01; Completion date: 2015-07-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if using the combination of standard chemotherapy (gemcitabine and carboplatin) plus this new drug (panitumumab) can help to shrink the tumor before the patient undergoes surgery for bladder cancer.

Detailed description:

Arms: arm 1: Patients will receive four cycles of GCaP administered every 21 days. Panitumumab will be administered intravenously at a dose of 9mg/kg on day 1. Gemcitabine 1,000 mg/m2 on day 1 and 8 and carboplatin AUC 4.5 on day 1 will be administered intravenously on a 21-day cycle. A total of four cycles of therapy will be administered at 21-day intervals followed by radical cystectomy.
Interventions: intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Panitumumab intervention 4: radical cystectomy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01931865
Conditions: Pain
Keywords: cancer pain, radiation therapy, surgery, incobotulinum toxin
Sponsor: Yale University
Start date: 2012-09-01; Completion date: 2015-07-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to investigate the safety and effectiveness of botulinum toxin A (Xeomin) ® injections in patients who suffer from focal pain in areas of radiation and/or surgery as a result of cancer treatment. Our hypothesis is that injection of incobotulinum toxin A into an area of local pain, at or around the area of a post-surgical/post radiation scar, relieves the focal cancer pain.

Detailed description:
Please contact the PI for more detailed information.

Arms: arm 1: The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The ttoal dose will not exceed 100 units.
Interventions: intervention 1: IncobotulinumtoxinA
Intervention descriptions: intervention 1: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.

Protocol documents:
Clinical trial NCT01960855
Conditions: Rheumatoid Arthritis
Keywords: anti-inflammatory agents Joint Diseases Arthritis Musculoskeletal Disease antirheumatic agents
Sponsor: AbbVie
Start date: 2013-10-01; Completion date: 2015-07-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy.

Detailed description:

Arms: arm 1: Placebo twice daily (BID) for 12 weeks. arm 2: ABT-494 3 mg twice daily (BID) for 12 weeks. arm 3: ABT-494 6 mg twice daily (BID) for 12 weeks. arm 4: ABT-494 12 mg twice daily (BID) for 12 weeks. arm 5: ABT-494 18 mg twice daily (BID) for 12 weeks.
Interventions: intervention 1: ABT-494 intervention 2: Placebo
Intervention descriptions: intervention 1: ABT-494 capsule administered orally twice daily (BID). intervention 2: Placebo for ABT-494 capsule administered orally twice daily (BID).

Protocol documents:
Clinical trial NCT01961544
Conditions: Breast Neoplasms Breast Cancer
Keywords: Breast Cancer Metastatic
Sponsor: Eisai Korea Inc.
Start date: 2013-06-01; Completion date: 2015-07-01
Enrollment: 101 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of eribulin which is approved for the treatment of the patients in Korea with locally advanced or metastatic breast cancer who had received two to five prior chemotherapy regimens including anthracyclines and taxanes for advanced disease.

Subjects who meet the inclusion/exclusion criteria are administered of 1.4 mg/m2 of the investigational product intravenously in 2-5 min on day 1 and day 8 of every 21-day cycle. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of investigational product is stopped, and treatment termination assessment is performed within 30 days from the last treatment.

Detailed description:

Arms: arm 1: 1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days
Interventions: intervention 1: Eribulin mesylate
Intervention descriptions: intervention 1: 1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days

Protocol documents:
Clinical trial NCT01999192
Conditions: Rheumatoid Arthritis
Keywords: inadequate response to MTX Methotrexate rheumatoid Arthritis Phase 2b
Sponsor: Biotest
Start date: 2013-10-01; Completion date: 2015-07-01
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone.

The overall study duration is 24 weeks followed by a 24 week extension phase.

Detailed description:
The planned clinical study 986 (TREAT 2b) is a 24-week study in patients with Active rheumatoid arthritis (RA) who have had an inadequate response to Methotrexate (MTX) alone. The main phase of this study is followed by a 24-week extension phase for subjects meeting the respective entry criteria. Patients will be randomized to one of three different Active treatment groups or Placebo. The primary efficacy variable is the proportion of subjects with an ACR20 response after 12 weeks of double blinded treatment with the study medication based on observed cases in the FAS.

At Week 12, all subjects who had a minimum improvement of at least 20% (from baseline) in their tender joint count (TJC) and swollen joint count (SJC) continued on the same treatment. Subjects who had not demonstrated an improvement of at least 20% of TJC and SJC were assessed as non-responders. Non-responders who received placebo were randomized to an active treatment dose in a blinded manner. Non-responders who received active treatment were rolled up to the next highest dose in a blinded manner, apart from those already on the highest dose. These subjects remained on the highest dose.

Arms: arm 1: 25mg Tregalizumab s.c. weekly arm 2: 100mg Tregalizumab s.c. weekly arm 3: 200mg Tregalizumab s.c. weekly arm 4: Placebo s.c. weekly
Interventions: intervention 1: Tregalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: humanized anti-CD4 mAb intervention 2: identical end formulation buffer

Protocol documents:
Clinical trial NCT02025634
Conditions: Pain, Postoperative
Keywords: Pain, Postoperative Ofirmev Acetaminophen Analgesics, Non-Narcotic Arthroscopy
Sponsor: AdventHealth
Start date: 2013-11-01; Completion date: 2015-07-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.

Detailed description:
This is a randomized, placebo controlled, single blind study of intravenous (IV) acetaminophen in a postoperative arthroscopy patient population. Although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. In this study all participants will be injected with a standard of care intra-articular dose of ropivacaine HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml 0.9 % NS placebo (control).

The PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. All other pain medication or related treatment will be recorded. Statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. Further evaluation will examine if opioid consumption and total time in PACU differs between groups.

Arms: arm 1: Infusion of Intravenous acetaminophen (Ofirmev) arm 2: Infusion of 100 ml of 0.9 NS Normal Saline
Interventions: intervention 1: Intravenous Acetaminophen intervention 2: Placebo (0.9% Normal Saline infusion)
Intervention descriptions: intervention 1: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight. intervention 2: Infusion of 100 ml of 0.9% NS

Protocol documents:
Clinical trial NCT02049151
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung Tecemotide Placebo NSCLC L-BLP25
Sponsor: EMD Serono
Start date: 2014-03-01; Completion date: 2015-07-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tecemotide intervention 2: Placebo intervention 3: Cyclophosphamide (CPA) intervention 4: Saline (sodium chloride)
Intervention descriptions: intervention 1: Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression. intervention 2: Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression. intervention 3: CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m\^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide. intervention 4: Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent \[%\] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.

Protocol documents:
Clinical trial NCT02050321
Conditions: Malignant Melanoma
Sponsor: University of Arizona
Start date: 2013-12-01; Completion date: 2015-07-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We propose to conduct a phase 2 study to assess whether the addition of acitretin to vemurafenib therapy is able to decrease the rate of cutaneous squamous cell carcinoma (cSCC) development, a known side effect of vemurafenib therapy, in patients with advanced melanoma. Further, we seek a preliminary assessment as to whether the addition of acitretin to vemurafenib enhances the clinical efficacy of this anti-melanoma agent.

Detailed description:

Arms: arm 1: Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.
Interventions: intervention 1: Acitretin intervention 2: Vemurafenib
Intervention descriptions: intervention 1: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months intervention 2: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Protocol documents:
Clinical trial NCT02054481
Conditions: Psoriasis
Sponsor: Boehringer Ingelheim
Start date: 2014-02-01; Completion date: 2015-07-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.

Detailed description:

Arms: arm 1: BI 655066 s.c. arm 2: BI 655066 s.c. arm 3: BI 655066 s.c. arm 4: Ustekinumab s.c.
Interventions: intervention 1: BI 655066 intervention 2: BI 655066 intervention 3: Ustekinumab intervention 4: BI 655066
Intervention descriptions: intervention 1: Medium dose intervention 2: High dose intervention 3: None intervention 4: Low dose

Protocol documents:
Clinical trial NCT02058160
Conditions: Type 2 Diabetes
Sponsor: Sanofi
Start date: 2014-01-01; Completion date: 2015-07-01
Enrollment: 736 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.

Detailed description:
Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.

Arms: arm 1: FRC once daily (QD) for 30 weeks. Dose individually adjusted. arm 2: Insulin glargine 100 U/mL QD for 30 weeks. Dose individually adjusted.
Interventions: intervention 1: Insulin glargine/lixisenatide (HOE901/AVE0010) intervention 2: Insulin glargine (HOE901) intervention 3: Metformin (Background Drug)
Intervention descriptions: intervention 1: Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization.

Dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg. intervention 2: Insulin glargine was self-administered QD by SC injection at approximately the same time every day.

After screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). intervention 3: Pharmaceutical form: Tablet; Route of administration: Oral administration

Protocol documents: