ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01568866
Conditions: Multiple Myeloma
Keywords: multiple myeloma relapsed multiple myeloma
Sponsor: Amgen
Start date: 2012-06-20; Completion date: 2018-02-05
Enrollment: 929 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

Detailed description:

Arms: arm 1: Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle. arm 2: Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Interventions: intervention 1: Carfilzomib intervention 2: Bortezomib intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Carfilzomib is administered over 30 minutes as an infusion. intervention 2: Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval) intervention 3: Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.

Protocol documents:
Clinical trial NCT00445458
Conditions: Advanced Breast Cancer Advanced Malignant Solid Tumors Breast Neoplasms
Keywords: cancer HKI-272 neratinib paclitaxel Taxol breast cancer Nerlynx
Sponsor: Puma Biotechnology, Inc.
Start date: 2007-09-11; Completion date: 2018-02-07
Enrollment: 110 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.

Detailed description:

Arms: arm 1: Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 160 mg daily by mouth in combination with paclitaxel 80 mg/m\^2 weekly IV. arm 2: Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m\^2 weekly IV. arm 3: Part 2: Subjects with metastatic breast cancer who have not received more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m\^2 weekly IV. arm 4: Part 2: Subjects with metastatic breast cancer who have not received more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m\^2 weekly IV.
Interventions: intervention 1: HKI-272 intervention 2: Paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01136733
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Unresectable advanced or metastatic renal cell carcinoma
Sponsor: Eisai Inc.
Start date: 2010-08-05; Completion date: 2018-02-08
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lenvatinib intervention 2: Everolimus
Intervention descriptions: intervention 1: taken orally, once a day intervention 2: taken orally, once a day

Protocol documents:
Clinical trial NCT02576847
Conditions: Rosacea
Sponsor: Maruho Co., Ltd.
Start date: 2015-10-01; Completion date: 2018-02-08
Enrollment: 307 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.

Detailed description:

Arms: arm 1: Omiganan gel applied once daily
Interventions: intervention 1: Omiganan
Intervention descriptions: intervention 1: Topical gel

Protocol documents:
Prot_000.pdf: 



















































































SAP_001.pdf:
Clinical trial NCT02070978
Conditions: Lupus Erythematosus, Systemic
Keywords: Lupus Erythematosus, Systemic Atacicept 75 and 150 mg LTE
Sponsor: EMD Serono
Start date: 2014-07-29; Completion date: 2018-02-09
Enrollment: 253 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Atacicept 75 mg intervention 2: Atacicept 150 mg intervention 3: Atacicept 150 mg
Intervention descriptions: intervention 1: Participants who received atacicept 75 milligram (mg) as once-weekly subcutaneous injection in the core study ADDRESS II continued to receive this dose during this LTE study. Participants in this reporting arm received the medication up to a maximum of 143.7 weeks. intervention 2: Participants who received placebo in the core study ADDRESS II switched to receive atacicept 150 mg as once-weekly subcutaneous injection for up to a maximum of 97.7 weeks during this LTE study. intervention 3: Participants who received atacicept 150 mg in core study ADDRESS II continued to receive atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Protocol documents:
Clinical trial NCT01243944
Conditions: Polycythemia Vera
Keywords: INCB018424
Sponsor: Incyte Corporation
Start date: 2010-10-27; Completion date: 2018-02-09
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

Detailed description:

Arms: arm 1: Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy arm 2: Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Interventions: intervention 1: ruxolitinib tablets intervention 2: Best Available Therapy (BAT)
Intervention descriptions: intervention 1: Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy intervention 2: Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

Protocol documents:
Clinical trial NCT02163993
Conditions: Migraine Headache
Sponsor: Eli Lilly and Company
Start date: 2014-07-07; Completion date: 2018-02-12
Enrollment: 414 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.

Detailed description:

Arms: arm 1: 5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period. arm 2: 50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. arm 3: 120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. arm 4: 300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. arm 5: Placebo given as SQ injections once every 28 days during a 12 week treatment period.
Interventions: intervention 1: Galcanezumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered SQ intervention 2: Administered SQ

Protocol documents:
Clinical trial NCT02441946
Conditions: Breast Cancer Hormone Receptor Positive Tumor Early-Stage Breast Carcinoma
Keywords: cyclin-dependent kinase (CDK) 4/6 inhibitor CDK 4 and 6 inhibitor
Sponsor: Eli Lilly and Company
Start date: 2015-08-01; Completion date: 2018-02-12
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.

Detailed description:

Arms: arm 1: Abemaciclib (150 milligrams \[mg\]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.

All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks. arm 2: Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.

All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks. arm 3: Anastrozole (1 mg) is given orally QD for 2 weeks.

All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.
Interventions: intervention 1: Abemaciclib intervention 2: Loperamide intervention 3: Anastrozole
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01435122
Conditions: Carcinoid Tumor
Keywords: progressive advanced carcinoid tumors advanced unresectable metastatic cancerous tumors neuroendocrine digestive tract lungs renal ovarian thymic hepatic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2011-10-25; Completion date: 2018-02-13
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to see whether Axitinib will help prolong the time that the patient's carcinoid tumors remain stable, and to examine their treatment response through testing. Researchers also want to find out if Axitinib is safe and tolerable.

Detailed description:
This is a bi-institutional, prospective phase II, open-label study. The target population is comprised of adult patients with histologically confirmed unresectable or metastatic carcinoid tumors. Carcinoid tumors are defined as well to moderately differentiated neuroendocrine tumors of the digestive tract and lungs. Patients with metastatic carcinoid tumors of unknown primary as well as rare primaries (renal, ovarian, thymic, hepatic) will also be eligible. Patients will be drawn from two institutions Moffitt Cancer Center (MCC) and The University of California, San Francisco (UCSF).

Arms: arm 1: The investigational drug used in this study is axitinib, and is available as tablets.

You will take the tablet orally with food. Doses should be taken around 12 hours apart continuously, without scheduled breaks. If you vomit anytime after taking a dose do not take another tablet to "make up the dose" but instead continue taking your next dose as planned.

Any missed dose may be taken late (up to 3 hours before the next scheduled dose); otherwise it should be skipped. If doses are missed or vomited, please keep track of this and report at your next visit.
Interventions: intervention 1: Axitinib
Intervention descriptions: intervention 1: Axitinib Administration as outlined in Arm description

Protocol documents:
Clinical trial NCT00699491
Conditions: Male Breast Carcinoma Recurrent Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7
Sponsor: National Cancer Institute (NCI)
Start date: 2008-10-31; Completion date: 2018-02-14
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may be a better treatment for breast cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To establish the recommended dose level for the phase II trial. (Phase I) II. To examine the safety profile of this combination in patients with metastatic breast cancer. (Phase I) III. To assess the anti-tumor activity (in terms of overall response rate) and toxicity profile of IMC-A12 (cixutumumab) in combination with temsirolimus in patients with metastatic breast cancer. (Phase II)

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival distributions (as well as the 6-month PFS rate).

II. To evaluate the in vivo mechanisms of action of temsirolimus in combination with IMC-A12 and to examine potential biomarker predictors of treatment response.

OUTLINE: This is a phase I, dose-escalation study of cixutumumab followed by a phase II study.

Patients receive temsirolimus intravenously (IV) over 30 minutes and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 (cixutumumab is given on days 8, 15, and 22 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 2 (phase I) or 5 (phase II) years.

Arms: arm 1: Patients receive temsirolimus IV over 30 minutes and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 (cixutumumab is given on days 8, 15, and 22 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Cixutumumab intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study intervention 4: Temsirolimus
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Given IV

Protocol documents:
Clinical trial NCT01134198
Conditions: Cocaine Dependence
Keywords: Cocaine Dependence
Sponsor: New York State Psychiatric Institute
Start date: 2010-05-01; Completion date: 2018-02-14
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research will evaluate the impact of blocking central and peripheral glucocorticoid receptors on stress sensitivity and the risk of relapse to cocaine use in treatment-seeking cocaine-dependent individuals. Mifepristone (RU-486) will be the glucocorticoid antagonist used.

Detailed description:
This study attempts to reduce relapse risk by blocking glucocorticoid receptors, and thus allow some of the changes in the brain caused by cocaine to redress themselves

Arms: arm 1: Mifepristone 600mg arm 2: Placebo
Interventions: intervention 1: Mifepristone intervention 2: placebo
Intervention descriptions: intervention 1: Mifepristone 600mg, 3x/wk for 4 weeks intervention 2: placebo

Protocol documents:
Clinical trial NCT01402817
Conditions: Neurofibromatosis NF1 Plexiform Neurofibromas
Keywords: NF1 plexiform neurofibromas Sunitinib Sutent®
Sponsor: Indiana University
Start date: 2012-03-01; Completion date: 2018-02-14
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study to determine if adults and children with neurofibromatosis type 1 who have plexiform tumors given Sutent® respond to this drug therapy.

Detailed description:
This is an open-label pilot study to evaluate the efficacy of Sutent® in individuals with NF1 who have clinically significant plexiform tumors. A secondary goal of this study will be to seek to improve on current and novel tools to evaluate tumor response of plexiform tumors. The rationale for this study arises from the response of human and murine NF1 cells to Sutent® in vitro and the clinical response of individuals with NF1 using a similar drug,Gleevec®. Following enrollment adult subjects will start receiving Sutent® by month at 25mg once a day for 28 days. Subjects will then have 14 days without taking any Sutent®. If tolerated the dose will be increased to 37.5mg and 50mg with the same regimen (28 days of taking medication followed by 14 without). Children will be started on a dose of 10mg/m2/day once a day for 28 days. They will then have 14 days without taking any Sutent®. If tolerated the dose will be increased to 15mg/m2/day.

Arms: arm 1: Upon enrollment, subjects will receive Sutent® orally. Adults (Age \>18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.
Interventions: intervention 1: Sutent®/Sunitinib
Intervention descriptions: intervention 1: Upon enrollment, subjects will receive Sutent® orally. Adults (Age \>18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.

Protocol documents:
Clinical trial NCT02255357
Conditions: Cocaine Dependence
Keywords: Oxytocin Vasopressin Cocaine
Sponsor: New York State Psychiatric Institute
Start date: 2015-03-01; Completion date: 2018-02-14
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This proposal describes a combined laboratory and clinical trial preliminary investigation to advance medication development for cocaine dependence. The main objective is to test whether intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response to intranasal desmopressin. These measures will be tested during a 7-day inpatient abstinence induction hospitalization. For those patients with family and work obligations, an outpatient abstinence induction procedure is available. The response to the desmopressin challenge will be compared to a cohort of matched control subjects. After abstinence induction, cocaine dependent patients enter a 6-week, double blind, randomized, placebo-controlled trial of 24 IU of intranasal oxytocin vs. placebo, to monitor if this reduces the relapse risk.

Detailed description:
This study is based on the findings that chronic stress, caused in these patients by cocaine dependence, increases the sensitivity of the Hypothalamo-Pituitary-Adrenal (HPA) axis and CNS stress pathways to vasopressin. For their part, oxytocin systems, in chronic stress, acquire an increasing moderating effect on CNS stress system and the HPA axis. Cocaine dependence generates increased responsivity of stress system to oxytocin in the face of depleted oxytocin stores; thus creating an environment where exogenous oxytocin could exert a strong regulatory effect. Intranasal administration provides a convenient method to deliver these small peptides to the brain. Studying the feasibility of this approach, and its applicability to the treatment of cocaine-dependent patients, will be a goal of the study. The main outcome of this study will be the number of consecutive days of abstinence from cocaine after abstinence induction. A secondary outcome will be: Is the acute effect of intranasal oxytocin on desmopressin-induced ACTH secretion associated with the number of days of continued abstinence.

Arms: arm 1: Solution containing only the excipients of the original solution without Oxytocin. arm 2: Intranasal Oxytocin 24 IU per day.
Interventions: intervention 1: Placebo intervention 2: Intranasal Oxytocin
Intervention descriptions: intervention 1: Solution containing only the excipients of the original solution without Oxytocin. intervention 2: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm

Protocol documents:
Prot_000.pdf: 







































































SAP_001.pdf:
Clinical trial NCT02410382
Conditions: Head and Neck Cancer Non-small Cell Lung Cancer
Keywords: cancer radiation therapy chemotherapy dexamethasone corticosteroids
Sponsor: University of Arizona
Start date: 2014-08-27; Completion date: 2018-02-16
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will look at how dexamethasone and placebo influence radiation fatigue, quality of life and number of treatment days missed during radiation therapy or radiation therapy and chemotherapy for cancer.

Detailed description:
Subjects will randomly receive either dexamethasone or placebo and begin the study medication during the midpoint of their radiation treatment. Study medication will be taken for 14 straight days then stopped. Fatigue and quality of life will be measured weekly with short patient completed surveys. The number of breaks taken during radiation treatment will also be tracked. For safety, blood sugar levels will be checked with finger stick blood draws because dexamethasone is known to cause these levels to increase. Study participation will be approximately 3 months.

Arms: arm 1: Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days arm 2: Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days
Interventions: intervention 1: Dexamethasone intervention 2: Placebo
Intervention descriptions: intervention 1: oral dexamethasone 4 mg bid for 14 days intervention 2: oral placebo

Protocol documents:
Prot_SAP_000.pdf: