ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01708629
Conditions: Plaque Psoriasis
Keywords: psoriasis, brodalumab, AMG 827
Sponsor: Bausch Health Americas, Inc.
Start date: 2012-09-01; Completion date: 2015-10-01
Enrollment: 1881 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Detailed description:
This study assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Arms: arm 1: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. arm 2: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. arm 3: Administered by subcutaneous (SC) injection per the labeled dosing regimen. arm 4: Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Interventions: intervention 1: 210 mg brodalumab intervention 2: 140 mg brodalumab intervention 3: ustekinumab intervention 4: placebo
Intervention descriptions: intervention 1: 210 mg brodalumab administered SC intervention 2: 140 mg brodalumab administered SC intervention 3: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen. intervention 4: placebo administered SC

Protocol documents:
Clinical trial NCT01987960
Conditions: Post-traumatic Stress Disorder PTSD
Sponsor: H. Lundbeck A/S
Start date: 2013-12-01; Completion date: 2015-10-01
Enrollment: 417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.

Detailed description:

Arms: arm 1: Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) arm 2: Brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day.
Interventions: intervention 1: Placebo intervention 2: Brexpiprazole
Intervention descriptions: intervention 1: Once daily, tablets, orally intervention 2: 1 to 3 mg/day, once daily dose, tablets, orally

Protocol documents:
Clinical trial NCT00189137
Conditions: Sarcoma, Soft Tissue
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2004-08-01; Completion date: 2015-10-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Detailed description:
The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ifosfamide and doxorubicin vs gemcitabine and docetaxel
Intervention descriptions: intervention 1: Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.

Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.

All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.

Protocol documents:
Clinical trial NCT00372229
Conditions: Cytomegalovirus Infections
Sponsor: Hoffmann-La Roche
Start date: 2006-05-01; Completion date: 2015-10-01
Enrollment: 299 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Valganciclovir CMV Prophylaxis intervention 2: Valganciclovir (Pre-emptive CMV Therapy) intervention 3: Ganciclovir
Intervention descriptions: intervention 1: 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation. intervention 2: If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir. intervention 3: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.

Protocol documents:
Clinical trial NCT00463840
Conditions: Pancreatic Cancer
Keywords: Locally advanced pancreatic cancer oxaliplatin chemoradiation 5FU
Sponsor: NYU Langone Health
Start date: 2004-06-01; Completion date: 2015-10-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.

Detailed description:
Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine.

In summary, the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.

Arms: arm 1: Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery

Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;

Combined with :

5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).

Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.

Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):

Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.
Interventions: intervention 1: Oxaliplatin intervention 2: 5FU intervention 3: Radiation intervention 4: Surgery intervention 5: FOLFOX 6
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Protocol documents:
Clinical trial NCT00580372
Conditions: Multiple Myeloma
Sponsor: University of Arkansas
Start date: 2002-08-01; Completion date: 2015-10-01
Enrollment: 231 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This experimental study evaluates the effects of a series of intensive drug regimens as initial treatment for Multiple Myeloma followed by 2 bone marrow transplantations 4-6 months apart in support of high-dose Melphalan, followed by Interferon treatment indefinitely.

Detailed description:

Arms: arm 1: Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.
Interventions: intervention 1: VAD intervention 2: High-Dose cyclophosphamide intervention 3: Hemopoietic stem cell procurement intervention 4: EDAP intervention 5: Autologous Hemopoietic Stem Cell Transplant 1 intervention 6: Autologous Hemopoietic Stem Cell Transplant 2 intervention 7: Maintenance
Intervention descriptions: intervention 1: 3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20 intervention 2: Approximately 5-6 weeks after VAD 2 or 3:

Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1 intervention 3: Collection target = 10 x 10\^6 cells/kg intervention 4: Approximately 5-6 weeks after high-dose cyclophosphamide Etoposide 100 mg/m2/d d 1 - 4 CI Cisplatin 25 mg/m2/d d 1 - 4 CI Ara C l g/m2 d 5 Dexamethasone 40 mg d 1-5 intervention 5: 4-6 weeks after EDAP: Melphalan 100 mg/m2 days -1 and -2 intervention 6: 4-6 months after Transplant 1: Melphalan 100 mg/m2 days -1 and -2 intervention 7: 3 months after Transplant 2: Intron A 3 X 10\^6 units /m2 M-W-F subcutaneously until relapse

Protocol documents:
Clinical trial NCT00632359
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia CLL Lenalidomide Revlimid
Sponsor: M.D. Anderson Cancer Center
Start date: 2008-02-01; Completion date: 2015-10-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to reduce the level of leukemia in your body. The safety of this drug will also be studied.

Detailed description:
The Study Drug:

Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take lenalidomide by mouth every night each day for up to 12 months. You should swallow lenalidomide capsules whole, with water, at the same time each day. Do not break, chew, or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss a dose, it should not be made up on another day.

The dose and schedule of lenalidomide may be changed, depending on the side effects you may experience.

Study Visits:

Once a week during the first 4 weeks, blood (about 1 tablespoon) will be drawn for routine tests. Blood may be drawn more often if the dose of lenalidomide needs to be changed or if you experience side effects.

After the first 4 weeks, blood (about 1 tablespoon) will be drawn for routine tests every 2 weeks until the doctor thinks your dose of lenalidomide will not change. After this, blood (about 1 tablespoon) will then be drawn every 4 weeks for routine tests.

On Month 4 and 12 (+14 days), you will have a physical exam and blood (about 2-3 teaspoons) will be drawn to check the status of the disease.

On Month 4 and 12 (+14 days), and then every 3 months after that (unless your study doctor does not think it is necessary), you will have a bone marrow biopsy and aspirate to check the status of the disease.

Length of Study:

You will continue receiving the study drug for up to 12 months. You will continue having study visits for as long as the disease remains stable. You will be taken off study early if the disease gets worse or intolerable side effects occur.

Arms: arm 1: Lenalidomide 10 mg daily given for 12 months.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: 10 mg daily given for 12 months

Protocol documents:
Clinical trial NCT00748553
Conditions: Advanced or Metastatic Solid Tumors Advanced or Metastatic Breast Cancer
Sponsor: University of Utah
Start date: 2008-09-01; Completion date: 2015-10-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Detailed description:
The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.

Arms: arm 1: All participants enrolled.
Interventions: intervention 1: Azacitidine (Vidaza) intervention 2: Nab-paclitaxel (Abraxane)
Intervention descriptions: intervention 1: 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle intervention 2: 100mg/m2 weekly for 3 weeks of each 4-week cycle

Protocol documents:
Clinical trial NCT00832338
Conditions: Breast Neoplasms Breast Cancer Cancer of the Breast
Keywords: Breast cancer Tumors, Breast Cancer of the breast
Sponsor: Emory University
Start date: 2009-04-01; Completion date: 2015-10-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.

Detailed description:
Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow you to have less extensive surgery by shrinking the size of your cancer. The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, we will be able to determine if your cancer is responsive to chemotherapy. Prior to entering this study, a special test, called the Oncotype DX assay, will be performed on a small amount of your cancer from the biopsy you had at the time you were diagnosed with breast cancer, to determine the likelihood that your cancer will benefit from and shrink with chemotherapy. You will only be eligible to enter this study if the recurrence score determined using the Oncotype DX assay is 25 or greater. Patients with hormone receptor-positive breast cancers with recurrence scores greater than or equal to 25 have been previously demonstrated to obtain a significant benefit from chemotherapy given after surgery.

In addition, researchers would like to examine proteins present in your blood and proteins present in your breast tissue. These additional parts of the study are voluntary and are NOT required to participate in this study.

Arms: arm 1: Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Interventions: intervention 1: Docetaxel with Cytoxan intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles. intervention 2: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.

Protocol documents:
Clinical trial NCT00857246
Conditions: Gastric Cancer Stomach Cancer
Keywords: stomach cancer biologics antibody chemotherapy chemoradiation adjuvant therapy neoadjuvant therapy epidermal growth factor receptor combination therapy
Sponsor: NYU Langone Health
Start date: 2005-07-01; Completion date: 2015-10-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.

Detailed description:
The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer. To this end, this trial is evaluating the feasibility and treatment efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University (NYU). The combination of Irinotecan and Cisplatin has been shown to be synergistic and active against gastric carcinoma. This trial therefore builds upon NYU previous experience with the neoadjuvant administration of Irinotecan combined with Cisplatin as well as the reported enhanced activity of Irinotecan, Cisplatin and External beam radiation when combined with Cetuximab to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and gastro-esophageal junction (GEJ) cancers. The program includes: 1) systemic combination of Irinotecan, Cisplatin and Cetuximab used as an induction, 2) followed by potentially curative gastrectomy or GEJ resection, and 3) post-operative chemoradiation as reported in the Intergroup study with the addition of Cetuximab.

Arms: arm 1: 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
2. Surgery (starts 3-4 weeks after induction treatment).
3. Chemoradiation treatment (starts 4-6 weeks after surgery):

weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Interventions: intervention 1: Cetuximab intervention 2: Irinotecan intervention 3: Cisplatin intervention 4: Surgery intervention 5: 5-FU intervention 6: Radiation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents: