ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00944047
Conditions: Breast Cancer
Keywords: invasive breast cancer HER2 primary breast cancer neo-adjuvant therapy Trastuzumab Nab-paclitaxel
Sponsor: University of Kansas Medical Center
Start date: 2009-07-01; Completion date: 2017-08-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.

Detailed description:
Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant chemotherapy has a number of potential advantages including increasing the chances for breast preservation at the time of surgery as well as it may improve the local control of the cancer. Several national breast cancer studies have shown that neoadjuvant chemotherapy was equal to chemotherapy given following surgery.

A standard treatment for stage II or Stage III invasive breast cancer with low HER2 expression is combination chemotherapyAdriamycin, Cytoxan,followed by a Taxane: given either before or after surgery), followed by surgery +/- radiation therapy.

The main purpose of chemotherapy however is to reduce the risk of recurrence of cancer and also make surgery more successful. HER2 is a receptor located on the surface of some cells. This receptor plays a role in regulating the growth of the cell, in addition to the growth of tumors. High levels of the HER2 receptor may predict those women who benefit from treatment with agents such as Herceptin that target HER2. Herceptin (Trastuzumab) is a drug that is effective both alone and in combination with standard chemotherapy. There is some data to suggest that patients whose tumors have low expression of the HER2 protein and are normal by FISH may also receive benefit from Herceptin.

Arms: arm 1: Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery
Interventions: intervention 1: nab-paclitaxel intervention 2: trastuzumab intervention 3: Doxorubicin intervention 4: cyclophosphamide intervention 5: Growth Factor Support intervention 6: Surgery
Intervention descriptions: intervention 1: 100 MG/M2 IV over 30 minutes once a week for 12 weeks intervention 2: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks intervention 3: 60 MG/M2 every two weeks for a total of 4 cycles intervention 4: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above) intervention 5: * All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
* Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician. intervention 6: * After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
* All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.

Protocol documents:
Clinical trial NCT00945815
Conditions: Leukemia
Keywords: B-cell adult acute lymphoblastic leukemia L1 adult acute lymphoblastic leukemia L2 adult acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia
Sponsor: SWOG Cancer Research Network
Start date: 2010-09-01; Completion date: 2017-08-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving epratuzumab together with cytarabine and clofarabine may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab together with cytarabine and clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.

Detailed description:
OBJECTIVES:

* To test whether the complete remission (CR) rate (CR and incomplete CR) in adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia is sufficiently high after treatment with cytarabine, clofarabine, and epratuzumab to warrant further investigation.
* To estimate the frequency and severity of toxicities associated with the dosing schedule of cytarabine, clofarabine, and epratuzumab used in this study.
* To investigate, preliminarily, the effect of laboratory correlates (minimal post-treatment residual disease) and cytogenetic factors on prognosis in this patient population. (Not reported here due to limited MRD data)

OUTLINE: This is a multicenter study.

Patients receive cytarabine IV over 2 hours on days 1-5, clofarabine IV over 1 hour on days 2-6, and epratuzumab IV over at least 1 hour on days 7, 14, 21, and 28 in the absence of disease progression or unacceptable toxicity\*.

NOTE: \* Prophylactic intrathecal methotrexate is required for patients \< 22 years of age, and is recommended (but not required) for patients ≥ 22 years of age.

Blood samples, bone marrow samples, and/or tumor tissue samples may be collected for further laboratory analysis.

Patients are followed up every 3 months for 2 years, then annually for 3 years (until 5 years after registration).

Arms: arm 1: AraC 1 g/m2/d IV Days 1-5 clofarabine 40 mg/m2/d IV Days 2-6 epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28 acetaminophen 650 mg/d PO Days 7, 14, 21, 28 diphenhydramine 50 mg/d IV Days 7, 14, 21, 28 IT methotrexate 12 mg IT at least 1 wk apart during induction All give 1 cycle
Interventions: intervention 1: epratuzumab intervention 2: clofarabine intervention 3: cytarabine intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01032850
Conditions: Hepatocellular Carcinoma
Keywords: INST 0820 sorafenib capecitabine hepatocellular carcinoma lung nexavar xeloda liver cancer
Sponsor: New Mexico Cancer Research Alliance
Start date: 2009-09-01; Completion date: 2017-08-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following:

* how effective this combination of study drugs will be in treating HCC
* how long subjects respond to these study drugs
* what types of side effects can be expected, and
* how severe the side effects are

All subjects in this study will receive:

* Sorafenib twice a day by mouth
* Capecitabine twice a day by mouth

Treatment will be given in a 28-day treatment cycle.

Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days 1-7 and 15-21 of the cycle

Detailed description:
Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world. HCC disproportionately affects men, with four times as many men developing the disease as women. In 2002, approximately 626,000 cases of HCC were reported worldwide (15,000 in the United States and 53,600 in Europe), and more than 600,000 deaths (about 13,000 Americans and 57,000 Europeans) due to HCC were reported. The five-year relative survival rate is about seven percent.

The Gem-Ox regimen has been used in the treatment of pancreatic cancer with encouraging results. Preliminary results of the Gem-Ox combination have been encouraging as well.Based on these observations the possibility of adding bevacizumab, a monoclonal antibody against VEGF, is being studied by other investigators. However, the combination of GEM-OX with bevacizumab is unlikely to be tolerated by HCC patients with Child-Pugh class B and C liver cirrhosis especially those with significant thrombocytopenia.It would seem therefore that the agents that could be tolerated by cirrhotic patients with advanced HCC would include capecitabine, erlotinib and sorafenib. We propose this phase II trial of sorafenib + capecitabine combination in patients with HCC and advanced liver cirrhosis who have a platelet count of ≥ 40,000 and a Child-Pugh (C-P) class A-and B liver cirrhosis with a life expectancy of ≥16 weeks.

Arms: arm 1: Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400mg) Capecitabine twice a day by mouth (850mg)
Interventions: intervention 1: Sorafenib & Capecitabine
Intervention descriptions: intervention 1: Intervention: Sorafenib twice a day by mouth (400mg), Capecitabine twice a day by mouth (850mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.

Protocol documents:
Clinical trial NCT01709032
Conditions: Thalassemia Major With Severe Transfusional Iron Overload
Keywords: Thalassemia Chelation Transfusion Safety
Sponsor: Children's Hospital of Philadelphia
Start date: 2012-09-01; Completion date: 2017-08-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We hypothesize that the combination treatment with deferasirox and deferiprone will be well tolerated and will result in significant improvement in cardiac and liver iron levels.

Detailed description:
Death and disability from iron related damage to the heart remain the most serious issue facing transfusion-dependent patients with thalassemia. However, over the past decade there have been several reports of improved survival and fewer cardiac complications. This improvement may be related to the availability of three chelators and also the accurate measurement of iron stores in various organs (e.g. heart and liver) with magnetic resonance imaging, which allows for personalized, tailored medical care for patients. The chelator characteristics, side effect profiles, and ability to remove iron from specific organs differ among the chelators, suggesting that combination therapy may be beneficial. Using two drugs at lower doses may be more tolerable than escalating doses of a single drug and may improve iron removal. The combination of deferoxamine and deferiprone has been shown to be particularly beneficial for reducing cardiac iron, but it requires a painful injection/infusion, which hinders adherence. This pilot study aims to investigate the safety of an oral-only combination chelator regimen (deferasirox and deferiprone) in individuals with thalassemia major with poorly controlled iron overload and to assess how well this chelator combination lowers iron stores over one year.

Arms: arm 1: None
Interventions: intervention 1: Deferasirox and deferiprone
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01969201
Conditions: Infertility
Keywords: In vitro fertilization (IVF) Assisted reproduction technologies (ART) GnRH-antagonist Follicle stimulating hormone (FSH)
Sponsor: IBSA Institut Biochimique SA
Start date: 2014-01-01; Completion date: 2017-08-01
Enrollment: 710 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.

Detailed description:

Arms: arm 1: 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) arm 2: 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
Interventions: intervention 1: Urofollitrophin intervention 2: Follitrophin alpha
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02001558
Conditions: Pressure Ulcer Spinal Cord Injuries
Keywords: Spinal cord injuries Pressure ulcer
Sponsor: University of Alabama at Birmingham
Start date: 2013-03-01; Completion date: 2017-08-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure ulcers compared to sterile saline among persons with spinal cord injury.

Detailed description:

Arms: arm 1: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily. arm 2: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily.
Interventions: intervention 1: Microcyn intervention 2: Sterile saline
Intervention descriptions: intervention 1: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24 intervention 2: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02101983
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia outpatient consolidation treatment
Sponsor: University of Rochester
Start date: 2011-05-01; Completion date: 2017-08-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients with acute myeloid leukemia. However, most patients receiving this therapy are required to be admitted to the hospital during their treatment course.

The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment given in an in-patient setting versus an out-patient setting.

Detailed description:
The primary objective of this study is to:

• To determine the incidence of grade 3 to 5 non-hematologic toxicity of high-dose cytarabine (HiDAC) for AML consolidation administered in an outpatient setting.

The secondary objectives of this study are to:

* To determine cost effectiveness of outpatient HiDAC consolidation versus the standard of care inpatient HiDAC consolidation.
* Evaluate patient quality of life (QOL) with this outpatient regimen in comparison to that with the standard inpatient regimen.

Arms: arm 1: Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. arm 2: Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.
Interventions: intervention 1: Cytosine Arabinoside
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02547363
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2015-11-01; Completion date: 2017-08-01
Enrollment: 373 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.

Detailed description:

Arms: arm 1: Treatment once daily for 3 days arm 2: Treatment once daily for 3 days
Interventions: intervention 1: LEO 43204 gel intervention 2: Vehicle gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02549352
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2015-11-01; Completion date: 2017-08-01
Enrollment: 391 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment

Detailed description:

Arms: arm 1: Treatment once daily for 3 days arm 2: Treatment once daily for 3 days
Interventions: intervention 1: LEO43204 gel intervention 2: Vehicle gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02831816
Conditions: Surgical Skin Preparation
Sponsor: Zurex Pharma, Inc.
Start date: 2016-08-03; Completion date: 2017-08-03
Enrollment: 640 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.

Detailed description:

Arms: arm 1: Isopropyl alcohol (IPA) 70% arm 2: Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% arm 3: ZP without IPA
Interventions: intervention 1: ZuraPrep intervention 2: ChloraPrep intervention 3: ZP Vehicle
Intervention descriptions: intervention 1: Apply topically. intervention 2: Apply topically. intervention 3: Apply topically.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01026142
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2010-01-26; Completion date: 2017-08-07
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Capecitabine intervention 2: Capecitabine intervention 3: Pertuzumab intervention 4: Trastuzumab
Intervention descriptions: intervention 1: 1000 mg/m2 po twice daily for 14 days every 3 weeks intervention 2: 1250 mg/m2 po twice daily for 14 days every 3 weeks intervention 3: 840 mg iv loading, then 420 mg iv every 3 weeks intervention 4: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks

Protocol documents:
Clinical trial NCT01732445
Conditions: Anemia Primary Myelofibrosis Secondary Myelofibrosis
Sponsor: Mayo Clinic
Start date: 2013-04-01; Completion date: 2017-08-10
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the efficacy (best overall response) of ruxolitinib (ruxolitinib phosphate) and danazol in patients with myelofibrosis suffering from anemia.

SECONDARY OBJECTIVES:

I. To evaluate the overall survival of patients with myelofibrosis suffering from anemia initiating ruxolitinib and danazol.

II. To evaluate the adverse event profile of ruxolitinib and danazol in patients with myelofibrosis suffering from anemia.

TERTIARY OBJECTIVES:

I. To evaluate quality of life (QOL) and patient-reported symptoms using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) with ruxolitinib and danazol for patients with myelofibrosis suffering from anemia.

OUTLINE:

Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) and danazol PO thrice daily (TID) on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician's discretion, patients may continue treatment past 6 courses if they are without disease progression.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Arms: arm 1: Patients receive ruxolitinib phosphate PO BID and danazol PO TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician's discretion, patients may continue treatment past 6 courses if they are without disease progression.
Interventions: intervention 1: ruxolitinib phosphate intervention 2: danazol intervention 3: quality-of-life assessment intervention 4: questionnaire administration
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Ancillary studies intervention 4: Ancillary studies

Protocol documents:
Clinical trial NCT02549339
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2015-11-13; Completion date: 2017-08-10
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment

Detailed description:

Arms: arm 1: Treatment once daily for 3 days arm 2: Treatment once daily for 3 days
Interventions: intervention 1: LEO 43204 gel intervention 2: Vehicle gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02727907
Conditions: Multiple Sclerosis
Sponsor: Biocad
Start date: 2015-02-12; Completion date: 2017-08-11
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years. Study hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original drug Rebif®.

Detailed description:

Arms: arm 1: Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks arm 2: Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage arm 3: Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 48 weeks, followed by 72 weeks of open-label BCD-033 usage
Interventions: intervention 1: BCD-033 (interferon beta 1a) intervention 2: Rebif (interferon beta 1a) intervention 3: Placebo
Intervention descriptions: intervention 1: Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks intervention 2: Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks intervention 3: Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Protocol documents: