ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00748189
Conditions: Leukaemia, Lymphocytic, Chronic
Keywords: Safety Untreated Efficacy Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia (CLL), untreated Ofatumumab Oncology
Sponsor: Novartis Pharmaceuticals
Start date: 2008-12-22; Completion date: 2018-05-17
Enrollment: 447 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.

Detailed description:
Chlorambucil, is currently approved for treatment of frontline chronic lymphocytic leukemia, especially, but not limited to the ailing and elderly patient population. Several other more aggressive treatment options are available (e.g. fludarabine), however they are not suitable for all CLL patients, especially the ailing and elderly, due to greater toxicity. Ofatumumab is effective with low toxicity. The addition of ofatumumab to chlorambucil offers potentially a more effective therapy, with limited toxicity. The objective of this study was to evaluate progression-free survival (PFS), overall response and overall survival in subjects with previously untreated CLL with ofatumumab added to chlorambucil versus chlorambucil.

Arms: arm 1: ofatumumab dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles arm 2: chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
Interventions: intervention 1: chlorambucil, tablets intervention 2: ofatumumab (GSK1841157) infusion
Intervention descriptions: intervention 1: 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles intervention 2: iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;

Protocol documents:
Clinical trial NCT03445195
Conditions: Complicated Urinary Tract Infection Acute Pyelonephritis
Sponsor: Entasis Therapeutics
Start date: 2018-01-17; Completion date: 2018-05-17
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.

Detailed description:
This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sulbactam-ETX2514 intervention 2: Placebo intervention 3: Imipenem-cilastatin
Intervention descriptions: intervention 1: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h. intervention 2: Matching 1g IV solution. intervention 3: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Protocol documents:
Prot_000.pdf: 



















































































































































SAP_001.pdf:
Clinical trial NCT03066622
Conditions: Headache
Sponsor: HealthPartners Institute
Start date: 2016-07-01; Completion date: 2018-05-20
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is a prospective, randomized, feasibility trial with the primary aim of comparing how well oral rapidly dissolving olanzapine controls primary headache pain when compared to the current treatment strategies used in emergency departments which often require intravenous or intramuscular medications.

Detailed description:
Primary Question:

Does oral rapidly dissolving olanzapine provide efficacious analgesia in patients with acute headache of non-organic origin (primary headache) who come to the ED for abortive therapy when compared to current standard of care?

Secondary Aim:

Additionally, the study will aim to see if oral rapidly dissolving olanzapine decreases 1) duration of ED length of stay and 2) need for IV access when compared to the current standard of care.

This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.

Arms: arm 1: IV Morphine or any medication per attending decision arm 2: oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
Interventions: intervention 1: Standard of Care as per attending physician intervention 2: 5mg rapidly dissolving olanzapine
Intervention descriptions: intervention 1: Patients are randomized to standard of care medication (as determined by attending physician) intervention 2: 5mg rapidly dissolving olanzapine

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02317016
Conditions: Non Small Cell Lung Cancer
Keywords: oncology cancer non small cell lung cancer anticancer drug pharmacokinetics AZD9291 rosuvastatin EGFR genes
Sponsor: AstraZeneca
Start date: 2015-03-10; Completion date: 2018-05-22
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of rosuvastatin, following multiple oral dosing of AZD9291 in the fasted state.

Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will provide for additional safety data collection. All patients from Part A who completed treatment may continue to receive AZD9291 80 mg once daily as a single agent until: disease progression; they are no longer deriving clinical benefit; or any other reason.

Detailed description:

Arms: arm 1: Sequential treatments of rosuvastatin alone followed by AZD9291 alone, followed by rosuvastatin + AZD9291.
Interventions: intervention 1: Pharmacokinetic sampling - AZD9291 intervention 2: AZD9291 tablet dosing intervention 3: Rosuvastatin intervention 4: Pharmacokinetic sampling - rosuvastatin intervention 5: Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention descriptions: intervention 1: Blood sampling to measure AZD9291 intervention 2: Part A: AZD9291 80mg tablet taken from Days 4 to 35. Part B: AZD9291 80mg tablet taken daily for 12 months. intervention 3: Rosuvastatin (BCRP substrate) 20mg taken once daily on Days 1 and 32 (Part A) . intervention 4: Blood sampling to measure rosuvastatin levels intervention 5: Blood samples to measure levels of AZ5140 and AZ7550

Protocol documents:
Clinical trial NCT00901901
Conditions: Carcinoma, Hepatocellular
Keywords: Sorafenib (Nexavar) Erlotinib (Tarceva) First Line HCC
Sponsor: Bayer
Start date: 2009-05-21; Completion date: 2018-05-23
Enrollment: 732 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Detailed description:
European quality of life scale (5 dimensions) (EQ-5D)

Arms: arm 1: Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd) arm 2: Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Erlotinib (Tarceva) intervention 3: Placebo
Intervention descriptions: intervention 1: Sorafenib 400 mg twice daily intervention 2: Erlotinib 150 mg once daily intervention 3: Matching erlotinib placebo 150 mg once daily

Protocol documents:
Clinical trial NCT01431534
Conditions: Solid Tumors
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-01-30; Completion date: 2018-05-25
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objectives of this trial are to determine the recommended dose of ridaforolimus for pediatric participants with advanced solid tumors by measuring the number of participants experiencing dose-limiting toxicities (DLTs) while on different doses of ridaforolimus, and to characterize the pharmacokinetics of ridaforolimus in these participants. The primary hypotheses of this study are that 1) the DLTs observed will be dose-dependent and allow for definition of a maximum tolerated dose (MTD) and 2) at a safe and well tolerated dose, ridaforolimus geometric mean (GM) Day-5 blood area under the concentration-time curve at 24 hours (AUC0-24) exceeds 75% (or 1304-ng\*hr/mL) of the estimated GM Day-5, 40-mg AUC0-24 in adults.

Study-related visits concluded in August 2013. Participants who did not have disease progression, adequately tolerated therapy, and continued to meet eligibility criteria for 6 months after the enrollment period had been completed could continue treatment in an extension phase until they met discontinuation criteria or voluntarily withdrew.

Detailed description:

Arms: arm 1: Participants receive 22 mg/m\^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants can receive additional treatment in an extension phase of the study. arm 2: Participants receive 28 mg/m\^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants can receive additional treatment in an extension phase of the study. arm 3: Participants receive 33 mg/m\^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants can receive additional treatment in an extension phase of the study.
Interventions: intervention 1: Ridaforolimus
Intervention descriptions: intervention 1: Oral administration of 10 mg enteric-coated tablets at doses of 22 mg/m\^2, 28 mg/m\^2, or 33 mg/m\^2 based on body surface area (BSA), once daily for 5 consecutive days each week in consecutive 28-day cycles.

Protocol documents:
Clinical trial NCT01565499
Conditions: Breast Cancer
Keywords: Neoadjuvant nab-paclitaxel luminal breast cancer
Sponsor: Spanish Breast Cancer Research Group
Start date: 2012-04-17; Completion date: 2018-05-27
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy.

Detailed description:
The primary objective of the trial is to determine the percentage of patients with poor response \[residual cancer burden III (RCB-III) rate\] in contrast to good response \[residual cancer burden 0/I RCB-0/1\] measured by the Symmans criteria \[20\] at surgery, in patients with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.

The primary endpoint of the study is to determine the residual cancer burden grade III (RCB-III) after surgery.

The total number of patients to be included in this study is 78 patients.

The duration of the study, from first patient visit to last patient visit will be approximately 90 months (Including follow-ups)

Arms: arm 1: The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.
Interventions: intervention 1: Nab-paclitaxel
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01714817
Conditions: Lupus Nephritis
Sponsor: Bristol-Myers Squibb
Start date: 2013-01-22; Completion date: 2018-05-30
Enrollment: 695 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)

Detailed description:

Arms: arm 1: BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks arm 2: Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
Interventions: intervention 1: BMS-188667 intervention 2: Mycophenolate mofetil intervention 3: Prednisone intervention 4: Placebo matching with BMS-188667
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02174276
Conditions: Chronic Hepatitis B
Sponsor: Gilead Sciences
Start date: 2014-07-24; Completion date: 2018-05-30
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.

Detailed description:

Arms: arm 1: Participants will receive TDF for 48 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. arm 2: Participants will receive TDF plus GS-4774 2 yeast units (YU) for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. arm 3: Participants will receive TDF plus GS-4774 10 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. arm 4: Participants will receive TDF plus GS-4774 40 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.
Interventions: intervention 1: Tenofovir disoproxil fumarate intervention 2: GS-4774
Intervention descriptions: intervention 1: TDF 300 mg tablet administered orally once daily intervention 2: GS-4774 subcutaneous injection administered every 4 weeks for a total of 6 doses

Protocol documents:
Clinical trial NCT00741260
Conditions: Breast Cancer
Keywords: Solid Tumor erbB2+ Breast Cancer Prior trastuzumab Metastatic Neratinib HKI-272 Nerlynx HER2 PB-272
Sponsor: Puma Biotechnology, Inc.
Start date: 2008-12-09; Completion date: 2018-06-01
Enrollment: 105 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts.

In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group.

Additional subjects may be included at any dose level to further assess the safety and tolerability at that dose level.

In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive treatment with the combination of neratinib and capecitabine at the maximum tolerated dose level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be enrolled in Part 2.

Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the combination is discontinued due to intolerance the other test article can be administered alone.

The primary objectives of Part 1 are to assess the safety and tolerability, and to define the maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with advanced solid tumors.

The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1.

The secondary objective of Part 1 is to collect information on preliminary anti-tumor activity of the combination of neratinib and capecitabine.

Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine.

Detailed description:

Arms: arm 1: Neratinib 160 mg and Capecitabine 1500 mg/m\^2 arm 2: Neratinib 240 mg and Capecitabine 1500 mg/m\^2 arm 3: Neratinib 240 mg and Capecitabine 2000 mg/m\^2 arm 4: Neratinib 200 mg and Capecitabine 2000 mg/m\^2 arm 5: Neratinib 160 mg and Capecitabine 2000 mg/m\^2 arm 6: Neratinib and Capecitabine Maximum Tolerated Dose without prior lapatinib arm 7: Neratinib and Capecitabine Maximum Tolerated Dose with prior lapatinib
Interventions: intervention 1: Neratinib intervention 2: Capecitabine
Intervention descriptions: intervention 1: Neratinib orally once daily continually intervention 2: Capecitabine orally on days 1-14 of each 21 day cycle

Protocol documents:
Clinical trial NCT00730158
Conditions: Colorectal Neoplasms
Sponsor: Edward Chu, MD
Start date: 2008-12-01; Completion date: 2018-06-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our rationale for the therapeutic use of KD018 is its potential activity in reducing chemotherapy-induced toxicity, especially diarrhea.

Detailed description:
KD018 is an oral form of a spray dried aqueous extract composed of four main herbs, which have been used in the Orient for nearly 2000 years for a variety of GI symptoms including diarrhea and nausea/vomiting. Extensive pre-clinical research has been done with Chinese herbal medicine, and studies have documented significant anticancer activity in combination with various cytotoxic agents including Irinotecan, which is a semi-synthetic derivative of the natural alkaloid camptothecin and belongs to the class of topoisomerase I inhibitors. Irinotecan has been evaluated extensively as a single agent as well as in combination with other cytotoxic agents in several schedules. We recently completed a phase I study of irinotecan using the every-2-week schedule in combination with varying doses of KD018. Based on this phase I study, the dose of irinotecan that will be used in this study is 215 mg/m2.

Arms: arm 1: irinotecan+ KD018 arm 2: irinotecan + placebo
Interventions: intervention 1: KD018 intervention 2: Irinotecan intervention 3: Placebo
Intervention descriptions: intervention 1: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day. intervention 2: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m². intervention 3: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.

Protocol documents:
Clinical trial NCT01180049
Conditions: Non-Hodgkin's Lymphoma
Keywords: Mantle Cell Lymphoma Non-Hodgkin's Lymphoma temsirolimus
Sponsor: Pfizer
Start date: 2011-03-01; Completion date: 2018-06-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: temsirolimus intervention 2: temsirolimus
Intervention descriptions: intervention 1: 175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit intervention 2: 75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit

Protocol documents:
Clinical trial NCT02066311
Conditions: Systemic Lupus Erythematosus
Keywords: lupus SLE
Sponsor: Northwell Health
Start date: 2014-09-01; Completion date: 2018-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease in which the body's immune system attacks different parts of the body. SLE is characterized by inflammation that leads to tissue damage in different organ systems. Any organ system may be involved, including the skin, the joints, the kidneys, the nervous system, the heart, the lungs, and the blood. The exact cause of SLE is not known. Patients with SLE often have elevated levels of anti-double stranded DNA antibodies. These levels are often associated with disease flares and disease severity. These antibodies can bind to tissue leading to organ damage. Preventing these antibodies from binding to their targets may help decrease disease activity.

Protease inhibitors are medications that have been approved by the Food and Drug Administration (FDA) for use in the treatment of HIV (human immunodeficiency virus). Nelfinavir (also called viracept) is one of these protease inhibitors. Separate from their anti-viral effects, protease inhibitors have been found to decrease inflammation. These medications have been shown to interfere with binding of anti-double stranded DNA antibodies to their targets and may decrease inflammation in SLE. This research study tests whether the protease inhibitor, nelfinavir, will decrease anti-double stranded DNA antibody binding and decrease disease activity.

Detailed description:

Arms: arm 1: Nelfinavir tablets will be taken by oral administration, 750mg (three 250 mg tablets) three times a day
Interventions: intervention 1: Nelfinavir
Intervention descriptions: intervention 1: None

Protocol documents:
Prot_SAP_000.pdf: