ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01062009
Conditions: Critical Illness
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2008-11-01; Completion date: 2014-11-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is 1) to determine whether administration of intravenous zinc to critically ill children is safe, and 2) to determine an appropriate dose of zinc supplementation.

Detailed description:
Our recently published studies in children with septic shock demonstrated that pediatric septic shock is characterized by large scale repression of genes that either directly depend on normal zinc homeostasis or directly participate in zinc homeostasis. Functional validation studies demonstrated that nonsurvivors of pediatric septic shock have abnormally low serum zinc concentrations. A follow-up pilot study in a general population of critically ill children demonstrated that the presence of low plasma zinc concentrations is a prevalent problem in critically ill children. In addition, low plasma zinc concentrations correlate inversely with indices of inflammation and directly with the number of organ failures. These preliminary data, coupled with the expected safety of zinc supplementation, provided the rationale for a double blinded, prospective, placebo-controlled trial of zinc supplementation in critically ill children, with the two primary study endpoints to assess efficacy being highly clinically relevant: reduction of the lymphopenia rate and improvement of glucose homeostasis. Although the proposal was well-received, the primary concern precluding funding of this trial were lack of safety and dosing data for intravenous zinc. We have therefore developed a proposal for a Phase I/II study of safety and pharmacokinetics to address these concerns. It is anticipated that data generated through this proposal will provide the necessary preliminary data to re-submit our application for an interventional efficacy trial of zinc supplementation in critically ill children

Arms: arm 1: No intervention arm 2: 250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days arm 3: 500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days arm 4: 750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days
Interventions: intervention 1: Zinc sulfate
Intervention descriptions: intervention 1: Zinc sulfate 200 mcg/ml in Normal Saline

Protocol documents:
Clinical trial NCT01070810
Conditions: Septic Shock
Keywords: Septic Shock Sepsis
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2010-02-01; Completion date: 2014-11-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.

Detailed description:

Arms: arm 1: 50 ml D5W arm 2: 200mg Thiamine in 50ml D5W
Interventions: intervention 1: D5W intervention 2: Thiamine
Intervention descriptions: intervention 1: Dextrose 5% intervention 2: Thiamine 200mg in 50ml D5W

Protocol documents:
Clinical trial NCT01091454
Conditions: Triple-negative Breast Cancer
Keywords: stage IV breast cancer triple-negative breast cancer male breast cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2010-06-01; Completion date: 2014-11-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from spreading.

Detailed description:
PRIMARY OBJECTIVES:

I. To identify any clinical efficacy of brostallicin and cisplatin in the treatment of breast cancer patients having a triple negative (estrogen receptor \[ER\]/progesterone receptor \[PR\]/HER2 negative) phenotype, as measured by progression-free survival (PFS) at 3 months.

SECONDARY OBJECTIVES:

I. To describe the confirmed tumor response rate of patients with measurable disease receiving brostallicin and cisplatin.

II. To describe the duration of response in patients with measurable disease receiving brostallicin and cisplatin.

III. To describe the 6-month progression-free survival of patients receiving brostallicin and cisplatin.

IV. To describe the overall survival (OS) of patients receiving brostallicin and cisplatin.

V. To evaluate the adverse event profile of the study regimen (adverse events graded using the Cancer Therapy Evaluation Program \[CTEP\] Active Version of the Common Terminology Criteria for Adverse Events \[CTCAE\]).

OUTLINE:

Patients receive cisplatin intravenously (IV) over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years.

Arms: arm 1: Patients receive cisplatin IV over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: brostallicin intervention 2: cisplatin
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT01093755
Conditions: Inflammation Barrett's Esophagus
Keywords: Barrett's Esophagus Radiofrequency ablation Patients post-radiofrequency ablation for Barrett's Esophagus.
Sponsor: Mayo Clinic
Start date: 2010-03-01; Completion date: 2014-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of inflammatory mediators (compared to conventional PPIs) in the esophagus, which could potentially lead to decreased recurrence of intestinal metaplasia following endoscopic ablation.

Detailed description:
Patients who achieve complete remission of intestinal metaplasia following ablation will be randomized (using concealed allocation, like the flip of a coin) to either intensive acid suppression with dexlansoprazole 60-90 mg/day or to symptom guided acid suppression with escalating doses of omeprazole (20-60 mg/day) for 6 months. Control of reflux will be assessed using 24 hour ambulatory pH monitoring. The need to escalate drug dosage at the 3 month visit will be determined by presence of excessive acid exposure on ambulatory pH monitoring. Biopsies of esophageal tissue will be obtained at baseline, then at 3 months and 6 months following randomization to measure changes in inflammatory biomarkers.

Arms: arm 1: Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months arm 2: Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Interventions: intervention 1: dexlansoprazole intervention 2: Omeprazole
Intervention descriptions: intervention 1: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months intervention 2: Escalating doses of omeprazole (20-60 mg/day) for 6 months

Protocol documents:
Clinical trial NCT01103180
Conditions: Borderline Personality Disorder
Keywords: Selective Serotonin Reuptake Inhibitor Escitalopram Borderline Personality Disorder Major Depressive Disorder Self-harm
Sponsor: University of Chicago
Start date: 2010-09-01; Completion date: 2014-11-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to examine the effectiveness the selective serotonin reuptake inhibitor (SSRI) escitalopram (also known by the trade name "Lexapro") in reducing desire to self-harm and actual self-harming among young adults with borderline personality disorder who are also currently depressed. Subjects will receive either escitalopram or placebo for eight weeks. During this time subjects will be make weekly visits to see the psychiatrist and record their thoughts and feelings several times each day using an electronic diary.

Detailed description:

Arms: arm 1: 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) arm 2: Inert placebo (sugar pill) taken daily for eight weeks
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)

Protocol documents:
Clinical trial NCT01133977
Conditions: Stage IV Melanoma
Sponsor: Eisai Inc.
Start date: 2010-04-01; Completion date: 2014-11-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary:

* Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of lenvatinib administered in combination with dacarbazine.
* Phase II: To evaluate the safety and tolerability of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone.

Secondary:

-Phase II: To make a preliminary assessment of the efficacy of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone.

Detailed description:
Safety was assessed by monitoring and recording all treatment emergent adverse events (AEs) and serious adverse events (SAEs); regular monitoring of clinical laboratory parameters; periodic measurement of vital signs and electrocardiograms (ECGs); dose limiting toxicities; performance of physical examinations; concomitant medications and procedures.

Arms: arm 1: Participants received 16 mg, 20 mg or 22 mg lenvatinib once daily in combination with dacarbazine arm 2: Participants received lenvatinib per the maximum tolerated dose (MTD) as determined in the Phase Ib of the study in combination with dacarbazine arm 3: Participants received dacarbazine
Interventions: intervention 1: Lenvatinib intervention 2: Lenvatinib intervention 3: Dacarbazine
Intervention descriptions: intervention 1: Lenvatinib tablets administered orally at doses of 16 mg, 20 mg, or 22 mg, once daily continuously over 3 weeks (21 days) during each 21-day cycle intervention 2: Lenvatinib 20 mg (MTD/recommended Phase 2 dose as determined in Phase 1b of the study) administered once daily continuously over 3 weeks (21 days) during each 21-day cycle intervention 3: Dacarbazine (1000 mg/m2) infusion over 60 minutes on Day 1 of each 21-day cycle.

Protocol documents:
Clinical trial NCT01136967
Conditions: Unresectable Stage III Stage IV Melanoma
Sponsor: Eisai Inc.
Start date: 2010-08-01; Completion date: 2014-11-01
Enrollment: 182 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the objective response rate of lenvatinib in previously treated participants with American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma and disease progression.

Detailed description:
This was a Phase 2, multicenter, open-label, 2-cohort, 2-stage study that assessed the ORR of lenvatinib in previously treated participants with AJCC unresectable Stage III or Stage IV melanoma and disease progression. Cohort 1 enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma, and is referred to as Cohort 1 or V600E BRAF negative. Other less common BRAF activating mutations were allowed as long as the participant did not receive a BRAF-targeted therapy. Cohort 2 enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy, and is referred to as Cohort 2 or V600E BRAF positive. Eligible participants had measurable disease according to RECIST 1.1.

Arms: arm 1: Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. arm 2: Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy.
Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.

Protocol documents:
Clinical trial NCT01227577
Conditions: Chronic Myelogenous Leukemia in Chronic Phase
Keywords: CML Chronic Myelogenous Leukemia Leukemia CML-CP Nilotinib
Sponsor: Novartis Pharmaceuticals
Start date: 2010-11-01; Completion date: 2014-11-01
Enrollment: 128 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."

Detailed description:

Arms: arm 1: Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Protocol documents:
Clinical trial NCT01233687
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Recurrent progressive advanced
Sponsor: Ahmad Tarhini
Start date: 2011-08-01; Completion date: 2014-11-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I/II study of erlotinib and AMG 102 in previously treated subjects with advanced NSCLC. Subjects will be enrolled with recurrent or progressive advanced stage NSCLC that has been treated with at least one and a maximum of two prior chemotherapy regimens. The Phase I part of the study will enroll 8-16 subjects with the Phase II part enrolling 21-45 subjects.

The Phase I part of the study is designed to determine how safest the combination of AMG 102 and erlotinib is and the recommended dose for the Phase II part. The Phase II part is to determine whether the combination of AMG102 and erlotinib works enough to warrant further interest in this combination.

Detailed description:
While modest improvements have been made in survival and quality of life in patients with advanced NSCLC there is a need to explore new agents and combinations with novel mechanisms of action in an effort to improve clinical outcomes in this patient population. The HGF/c-MET pathway inhibition is a promising novel target in NSCLC. Preclinical evidence support the combined targeting of EGFR and HGF/c-MET pathways in NSCLC as a strategy that may result in enhanced antitumor activity. Inhibition of both HGF/c-Met and EGFR pathways can be accomplished by utilizing the combination of AMG 102 and erlotinib in patients with advanced NSCLC. Therefore, we propose a safety and efficacy, phase I/II clinical trial of the combination in patients with previously treated, advanced NSCLC.

Arms: arm 1: Combination of AMG 102 and erlotinib
Interventions: intervention 1: AMG 102 and erlotinib
Intervention descriptions: intervention 1: Dose Level -2 Dose level -1 Dose Level 0 AMG 102 5 mg/kg 7.5 mg/kg 15 mg/kg Erlotinib 150 mg 150 mg 150 mg

The first cohort of patients in the phase I portion will start at dose level 0 of AMG102.

Protocol documents:
Clinical trial NCT01236365
Conditions: Diabetes Mellitus, Insulin-Dependent Hypercholesterolemia
Keywords: Type 1 diabetes Children Statins Hypercholesterolemia Lipoproteins C reactive protein Continuous glucose monitors Adolescence Abdominal magnetic resonance imaging Toll like receptors Receptors of advanced glycation end products Nutrition
Sponsor: Nemours Children's Clinic
Start date: 2010-10-01; Completion date: 2014-11-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due to chronic increase in the blood sugars and inflammation. If there is also increased in cholesterol, it creates a highly abnormal environment not fully corrected by improved control of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its prevention and treatment, compelling in children. This grant proposal encompasses 3 separate, yet interrelated projects addressing different aspects of CVD risk in children with T1DM. Project #1: a randomized controlled trial on the safety and efficacy of a class of drugs called "statins", which lower bad cholesterol in the body, in children with diabetes and elevated bad cholesterol. We will measure changes in concentration of blood inflammatory markers and for the 1st time, correlate levels of these markers with changes in blood sugar as measured by continuous glucose sensors, instruments that measure the blood sugar continuously through a small needle under the skin. Project #2: is a laboratory study to investigate the genetics and concentration of key molecules that participate in the inflammatory cascade and atheromatous plaque formation that causes CVD. Expression levels in children with T1DM will be compared with those in healthy controls for the 1st time. Project #3: examines the use of abdominal aortic MRI to measure damage to the arteries in children with T1DM and healthy age-matched controls. The results of these studies will likely provide important new data on the use of statins in children with diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atorvastatin intervention 2: Atorvastatin Placebo
Intervention descriptions: intervention 1: 10 or 20 mg daily intervention 2: 10 or 20 mg daily

Protocol documents:
Clinical trial NCT01254188
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic myeloid leukemia, CML, nilotinib, myelogenous, Philadelphia chromosome
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-01; Completion date: 2014-11-01
Enrollment: 421 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Detailed description:

Arms: arm 1: 300 mg BID
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.

Protocol documents:
Clinical trial NCT01255904
Conditions: Sedation
Sponsor: Baylor College of Medicine
Start date: 2011-08-01; Completion date: 2014-11-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).

Detailed description:

Arms: arm 1: Oral Chloral and intranasal placebo arm 2: oral placebo and intranasal dexmedetomidine
Interventions: intervention 1: Chloral Hydrate intervention 2: Dexmedetomidine intervention 3: Oral placebo intervention 4: Intranasal placebo
Intervention descriptions: intervention 1: Oral chloral hydrate 50 mg/kg intervention 2: Intranasal dexmedetomidine 3 mcg/kg intervention 3: Oral saline administered intervention 4: Intranasal saline administered

Protocol documents:
Clinical trial NCT01270828
Conditions: Post Herpetic Neuralgia
Keywords: Control Release Pregabalin in Post Herpetic Neuralgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-03-01; Completion date: 2014-11-01
Enrollment: 806 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks intervention 2: Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks

Protocol documents:
Clinical trial NCT01283334
Conditions: Head and Neck Neoplasms Cancer of the Head and Neck
Keywords: Head and Neck Cancer Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Sponsor: Emory University
Start date: 2011-01-01; Completion date: 2014-11-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the drug RAD001 in combination with other chemotherapy drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination.

The investigators will test the safety of RAD001 in combination with Carboplatin and Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin and Cetuximab will not be varied as both these drugs are considered to be part of the current standard of care for patients with your condition.

Detailed description:

Arms: arm 1: Treatment arm with carboplatin, cetuximab and RAD001
Interventions: intervention 1: Carboplatin intervention 2: Cetuximab intervention 3: RAD001
Intervention descriptions: intervention 1: Will be given as a 30 minutes intravenous (IV) infusion on days 1, 8, and 15 of each 28 day cycle. The starting dose of carboplatin will be area under the plasma-concentration time curve (AUC) = 2 mg/ml.min. Appropriate dose reductions will be done for toxicity for subsequent cycles. intervention 2: Will be given on days 1, 8, 15 and 22 of each 29 day cycle. On week 1, a loading dose of 400 mg/m² will be given. From week 2 onwards, the dose of cetuximab will be 250 mg/m². intervention 3: For phase I, dose escalation will be 2.5 mg, 5 mg, 7.5 mg or 10 mg given orally on a daily basis.

Protocol documents: