ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01951157
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Sponsor: PharmaMar
Start date: 2013-09-11; Completion date: 2016-11-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients

Detailed description:
A randomized-controlled, three-arm, phase II study of lurbinectedin (PM01183) alone or in combination with gemcitabine and a control arm with docetaxel as second-line treatment in unresectable non-small cell lung cancer (NSCLC)patients to evaluate the antitumor activity as progression-free survival at four months (PFS4) of PM01183 alone or in combination with gemcitabine as using single agent docetaxel as a reference in the control arm as current standard of care and to analyze overall survival (OS), overall survival rate at 1-year (OS12), duration of response (DR), antitumor activity, as response rate (RR), safety and efficacy profiles of PM01183 alone and in combination with gemcitabine, to be preliminary compared with docetaxel, patients' quality of life (QoL), pharmacokinetics (PK) of PM01183, pharmacokinetic/pharmacodynamic (PK/PD)correlation and pharmacogenomics (PGx)to explore potential correlations between clinical outcomes and molecular parameters found in tumor and blood samples

Arms: arm 1: 75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks arm 2: 3.2 mg/m2 PM01183, day 1, 1-hour intravenous, every three weeks arm 3: 800 mg/m2 gemcitabine / 1.6 mg/m2 PM01183 both on day 1 and day 8, 30-minutes gemcitabine/1-hour PM01183 intravenous, every three weeks
Interventions: intervention 1: Docetaxel intervention 2: Gemcitabine intervention 3: Lurbinectedin (PM01183)
Intervention descriptions: intervention 1: Powder for solution for infusion intervention 2: Powder for solution for infusion intervention 3: Powder for concentrate for solution for infusion

Protocol documents:
Clinical trial NCT02373202
Conditions: Rheumatoid Arthritis
Sponsor: Sanofi
Start date: 2015-02-01; Completion date: 2016-11-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.

Secondary Objective:

To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.

Detailed description:
Total study duration was up to 62 weeks: Up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.

Arms: arm 1: Participants received sarilumab 150 mg, subcutaneous (SC) injection, once every two weeks (q2w) along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks. arm 2: Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks. arm 3: Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. arm 4: Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
Interventions: intervention 1: Sarilumab intervention 2: Sulfasalazine intervention 3: Leflunomide intervention 4: Bucillamine intervention 5: Tacrolimus intervention 6: Mizoribine
Intervention descriptions: intervention 1: Pharmaceutical form:solution intervention 2: Pharmaceutical form: Tablet Route of administration: Oral intervention 3: Pharmaceutical form: Tablet Route of administration: Oral intervention 4: Pharmaceutical form: Tablet Route of administration: Oral intervention 5: Pharmaceutical form: Capsule Route of administration: Oral intervention 6: Pharmaceutical form: Tablet Route of administration: Oral

Protocol documents:
Clinical trial NCT02722278
Conditions: Hypogonadism
Sponsor: Clarus Therapeutics, Inc.
Start date: 2016-03-01; Completion date: 2016-11-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Detailed description:
This is a multicenter, Phase 3, randomized, open-label, active-comparator group, efficacy (based on Cavg of T), and safety study in adult hypogonadal male subjects. Enrollment is based on criteria designed to select the general population of hypogonadal men. Study drug doses will be titrated using a dose-titration algorithm based on total T Cavg. Subjects may be androgen treatment-naïve or washed out of prior androgen replacement therapies.

Subjects must have 2 total T levels \< 300 ng/dL based on 2 blood samples obtained in the morning (AM) on 2 separate days approximately 7 days apart.

Approximately 180 subjects will be randomly assigned to receive open-label treatment in a 3:1 ratio of oral TU to Axiron (ie, approximately 135 subjects will be randomly assigned to oral TU and approximately 45 subjects will be randomly assigned to Axiron topical solution). Subjects who complete the study will receive approximately 105 days of treatment. Dose titrations will be based on the T Cavg from serial PK sampling obtained on day 21 and 56 of treatment. Primary efficacy will be based on percentage of subjects within eugonadal range at Visit 7.

A subset of approximately 30 subjects will participate in a cosyntropin stimulation test on Day 1 (before administration of study drug) and Day 106 after the last 24-hour PK sample has been drawn.

Arms: arm 1: Approximately 135 subjects will receive oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID). arm 2: Subjects randomly assigned to the Axiron treatment group will begin treatment at a dose of 60 mg every morning.
Interventions: intervention 1: Oral Testosterone Undecanoate intervention 2: Axiron Testosterone Topical Solution
Intervention descriptions: intervention 1: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL. intervention 2: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.

Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

Protocol documents:
Clinical trial NCT00500292
Conditions: Colorectal Cancer
Keywords: colorectal cancer zactima
Sponsor: Genzyme, a Sanofi Company
Start date: 2007-03-01; Completion date: 2016-11-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.

Detailed description:

Arms: arm 1: FOLFOX + Placebo vandetanib arm 2: FOLFOX + low dose vandetanib arm 3: FOLFOX + high dose vandetanib
Interventions: intervention 1: Vandetanib intervention 2: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
Intervention descriptions: intervention 1: once daily oral tablet two dose strengths intervention 2: intravenous infusion

Protocol documents:
Clinical trial NCT00536341
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia untreated minimally treated fludarabine rituximab lenalidomide
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-01-01; Completion date: 2016-11-01
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and rituximab, using a schedule similar to that examined by investigators at MD Anderson (J Clin Oncol 23(18):4079-88, 2005). Given that the optimal dose and schedule is not currently known, this trial will perform a phase I component followed by a phase II examination to further explore this regimen's activity.

Detailed description:
While progress has been made in treating CLL patients over the last decade, a cure remains elusive for many patients treated with standard therapies. The combination of fludarabine, a purine analog, and rituximab, a monoclonal antibody, is an effective and frequently used therapy for CLL. However, this drug combination is associated with increased toxicity. Lenalidomide has been shown to be less toxic and has been used to treat hematologic malignancies including CLL. We propose this Phase I/Phase II study to examine the combination of lenalidomide with a rituximab/fludarabine backbone.

Arms: arm 1: Phase I Non-stratified, dose-escalation: \>=3 patients per dose level. Safety and tolerability will be evaluated every 2 weeks during the active treatment. Doses of lenalidomide will be escalated, while the fludarabine and rituximab doses remain fixed.

Phase II The Phase II regimen will be chosen following a review of the Phase I data. Following selection of the Phase II schedule, 40 treatment naive patients will be enrolled and treated with the Phase II regimen every 28 days for up to 6 courses. For those patients achieving a CR after 3 cycles, one additional cycle of treatment will be administered beyond CR confirmation.
Interventions: intervention 1: lenalidomide intervention 2: Rituximab intervention 3: Fludarabine
Intervention descriptions: intervention 1: 2.5 mg orally (PO) daily, Days 8-28, Cycle 1; 5.0 mg PO daily, Days 8-28 Cycles 2-6 intervention 2: 375 mg/m2 Cycle 1 (split over Day 1 \& Day 2); 500 mg/m2 Day 1 of Cycles 2-6 intervention 3: 25 mg/m2 on Days 1, 2, and 3

Protocol documents:
Clinical trial NCT00580645
Conditions: Alcohol Drinking
Keywords: alcohol smoking cessation varenicline bupropion smoking cessation medications
Sponsor: Yale University
Start date: 2007-04-01; Completion date: 2016-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.

Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior.

Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.

Detailed description:

Arms: arm 1: varenicline 1mg/day or 2mg/day arm 2: Placebo Controlled
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: 2mg/day or 1mg/day with 1-week medication lead-in period. intervention 2: placebo

Protocol documents:
Clinical trial NCT00633594
Conditions: Mantle Cell Lymphoma
Keywords: Mantle Cell Lymphoma Rituximab Lenalidomide Bortezomib Phase 1/2
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-06-01; Completion date: 2016-11-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).

Detailed description:
The combination of lenalidomide with bortezomib has not been studied in patients with MCL, but feasibility and tolerability has been demonstrated in patients with multiple myeloma. Thus, almost every 2-drug combination of rituximab, lenalidomide, and bortezomib has been tested, or is being tested. We hypothesize that all three drugs are important in MCL, and therefore propose to combine all 3 agents (rituximab, bortezomib, and lenalidomide) in a schedule that is convenient to lymphoma patients.

Approximately 18 patients may be enrolled in the Phase I portion of the study. Approximately 45 patients are planned for enrollment in Phase II.

Arms: arm 1: Patients in Phase I \& II to receive treatment with rituximab, bortezomib and lenalidomide in 21-day cycles up to 6 cycles.

Phase I: Cohorts of 3 patients will be enrolled at escalating dose levels to determine the maximum tolerated dose (MTD). Doses may be de-escalated if necessary.

Phase II: patients will be treated with the MTD determined in Phase I.
Interventions: intervention 1: Rituximab intervention 2: Bortezomib intervention 3: Lenalidomide
Intervention descriptions: intervention 1: DL 1, DL 2, and DL 3: 375 mg/m2 IV Days 1, 8, and 15; Cycles 2-6: 375 mg/m2 IV Day 1

Same for DL-1. intervention 2: DL 1, DL 2, and DL 3: 1.3 mg/m2 IV Days 1, 4, 8, and 11

Same for DL-1. intervention 3: DL 1: 15 mg PO daily Days 1-14 followed by 7 days of rest

DL 2: 20 mg PO daily Days 1-14 followed by 7 days of rest

DL 3: 25 mg PO daily Days 1-14 followed by 7 days of rest

DL-1: 10 mg PO daily Days 1-14 followed by 7 days of rest

Protocol documents:
Clinical trial NCT00699556
Conditions: Alcohol Drinking
Keywords: alcohol nicotine smoking cessation smoking cessation medications
Sponsor: Yale University
Start date: 2006-01-01; Completion date: 2016-11-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.

Detailed description:

Arms: arm 1: Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. arm 2: Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.
Interventions: intervention 1: 21mg transdermal nicotine patch (Nicoderm CQ) intervention 2: 1mg nicotine nasal spray intervention 3: placebo nasal spray
Intervention descriptions: intervention 1: 21mg transdermal nicotine patch intervention 2: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol. intervention 3: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.

Protocol documents:
Clinical trial NCT00773422
Conditions: Smoking
Keywords: smoking lapse behavior smoking cessation varenicline naltrexone medication effect on smoking lapse behavior
Sponsor: Yale University
Start date: 2008-01-01; Completion date: 2016-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to examine how medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.

Detailed description:

Arms: arm 1: naltrexone (25mg) + varenicline (2mg) arm 2: varenicline 2mg arm 3: placebo control
Interventions: intervention 1: naltrexone intervention 2: varenicline intervention 3: placebo
Intervention descriptions: intervention 1: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8). intervention 2: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8). intervention 3: placebo

Protocol documents:
Clinical trial NCT00789581
Conditions: Breast Cancer
Keywords: Breast Cancer Adjuvant Doxorubicin Cyclophosphamide Paclitaxel Ixabepilone TITAN
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-12-01; Completion date: 2016-11-01
Enrollment: 614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, Phase III, open-label, multicenter study.

Detailed description:
Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel.

Arms: arm 1: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each. arm 2: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.
Interventions: intervention 1: Doxorubicin intervention 2: Cyclophosphamide intervention 3: Ixabepilone (Ixempra) intervention 4: Paclitaxel (Taxol)
Intervention descriptions: intervention 1: Doxorubicin 60 mg/m2 intervention 2: Cyclophosphamide 600 mg/m2 intervention 3: Ixabepilone 40 mg/m2 intervention 4: Paclitaxel 80 mg/m2

Protocol documents:
Clinical trial NCT00796419
Conditions: Lung Injury, Acute (ALI) Respiratory Distress Syndrome, Acute (ARDS)
Keywords: Acute lung injury (ALI) Acute respiratory distress syndrome (ARDS) Respiratory failure
Sponsor: Emory University
Start date: 2009-01-01; Completion date: 2016-11-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are similar conditions in which the lungs are critically injured by another inflammatory process in the body. Together they affect more than 150,000 people per year in the United States, with mortality approaching 50% and a financial burden estimated to exceed $5 billion. Fluid overload, weight gain, and reduced oncotic pressure (low blood proteins) are associated with prolonged need for mechanical ventilation and mortality in patients with ALI/ARDS. Historical studies have provided conflicting evidence for benefits with colloid or diuretic therapy in ALI/ARDS, but recent clinical trials have demonstrated significant improvements in blood oxygen levels. The mechanisms of these benefits are not yet certain, but appear to relate to albumin's (a protein medicine) specific ability to influence injury and inflammation in the lungs, thus improving the ability for the lung to repair and exchange oxygen.

The purpose of this project is to determine the effects of therapies that affect blood proteins on their ability to change the way the lungs and cardiovascular system (heart and blood vessels) function. Special measurements will be taken to understand how these protein medicines change the ability of the lung and whole body to recover from widespread injury, with additional measures of specific heart and lung function. This clinical trial randomizes ALI/ARDS patients with low blood protein levels to receive albumin (a natural blood protein that is known to influence inflammation) or hetastarch (a synthetic blood protein) with diuretic therapy targeted to improve respiratory function. Therapeutic effects on respiratory function and blood oxygen levels, extravascular lung water, oncotic pressure, lung fluid removal, and heart function will be characterized. This trial will advance our understanding of treatment of ALI/ARDS and the factors that affect fluid balance in the lungs of these patients.

Funding Source - FDA Office of Orphan Products Development (OOPD)

Detailed description:

Arms: arm 1: Intravenous 5% human albumin arm 2: Intravenous 6% hetastarch
Interventions: intervention 1: 5% human albumin intervention 2: 6% hetastarch
Intervention descriptions: intervention 1: Intravenous administration of 250 milliliters (mL) 5% human albumin every 8 hours for 5 days intervention 2: Intravenous administration of 250mL 6% hetastarch every 8 hours for 5 days

Protocol documents:
Clinical trial NCT01000987
Conditions: Alcohol Reactivity
Keywords: alcohol reactivity smoking cessation medications
Sponsor: Yale University
Start date: 2009-10-01; Completion date: 2016-11-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.

Detailed description:

Arms: arm 1: varenicline 1mg/day or 2mg/day arm 2: placebo
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: 1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. intervention 2: placebo

Protocol documents: