ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01378975
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2011-07-01; Completion date: 2015-07-01
Enrollment: 146 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma \[except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors\]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Detailed description:

Arms: arm 1: Participants who had not received previous treatment for brain metastases \[i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases\] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor. arm 2: Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
Interventions: intervention 1: Vemurafenib
Intervention descriptions: intervention 1: 960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Protocol documents:
Clinical trial NCT01415921
Conditions: Heart Failure
Keywords: heart failure autonomic function sympathovagal balance cholinesterase inhibitors pharmacology
Sponsor: NYU Langone Health
Start date: 2011-10-01; Completion date: 2015-07-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Heart failure, a common heart disease affecting nearly 6 million Americans, is associated with high rates of hospitalization and death. Abnormalities in the autonomic nervous system are thought to play an important role in the progression of heart failure. This proposal aims to determine whether novel application of pyridostigmine, a drug currently approved by the FDA only for the treatment of neuromuscular disease, can improve autonomic nervous system function in heart failure patients.

Detailed description:
Autonomic dysregulation of the cardiovascular system, characterized by heightened sympathetic activity and withdrawal of parasympathetic activity promotes progression of heart failure. Pharmacological blockade of sympathetic overactivity is associated with reduced mortality risk, but there are few data on pharmacologic augmentation of parasympathetic withdrawal. Acetylcholinesterase inhibitors augment parasympathetic neurotransmission by blocking the enzymatic breakdown of acetylcholine at cholinergic receptor sites. Pyridostigmine is a short-acting, reversible acetylcholinesterase inhibitor approved by the FDA for the treatment of myasthenia gravis. Investigators propose a Phase II prospective randomized, double-blind trial to compare 12 weeks of treatment with ascending doses of pyridostigmine (15, 30, and 60 mg every 8 hours) vs. matching placebo in 60 patients with symptomatic chronic heart failure associated with left ventricular systolic dysfunction.

Arms: arm 1: Forced titration protocol 15-60 mg every 8 hours as tolerated arm 2: Matching placebo forced titration 15-60 mg as tolerated
Interventions: intervention 1: Pyridostigmine Bromide
Intervention descriptions: intervention 1: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue.

Protocol documents:
Clinical trial NCT01436500
Conditions: Hepatorenal Syndrome
Keywords: Hepatorenal Syndrome HRS ifetroban
Sponsor: Cumberland Pharmaceuticals
Start date: 2011-10-01; Completion date: 2015-07-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.

Detailed description:

Arms: arm 1: 60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. arm 2: 60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 1 HRS. arm 3: 60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. arm 4: 60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. arm 5: 60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. arm 6: 60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. arm 7: 60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. arm 8: 60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. arm 9: 60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 2 HRS.
Interventions: intervention 1: Ifetroban Injection intervention 2: Placebo
Intervention descriptions: intervention 1: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose intervention 2: Sterile water with 5% Dextrose

Protocol documents:
Clinical trial NCT01438710
Conditions: Renal Failure Tremors
Sponsor: Veloxis Pharmaceuticals
Start date: 2011-12-01; Completion date: 2015-07-01
Enrollment: 44 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro compared with Prograf or generic tacrolimus

Detailed description:
This is a 2 sequence, open-label, multicenter, prospective Phase 3b clinical study to access drug-induced hand tremors in stable kidney transplant subjects converted from Prograf (tacro-limus, Astellas Pharma US, Inc., Deerfield, IL) or generic tacrolimus twice daily (b.i.d.) to LCP-Tacro tablets (tacrolimus, Veloxis Pharmaceuticals A/S, Horsholm, Denmark) once daily (q.d.). The trial is designed to determine if the test drug LCP-Tacro, is associated with fewer and/or less severe drug-induced hand tremor than observed with Prograf or generic tacrolimus treatment; each therapy is to be concomitantly administered with mycophenolate mofetil (MMF), mycophenolate sodium (MPS), including generic versions of each, and/or prednisone or equivalent as long as doses remain stable during the study. All prophylaxis and other medication will be allowed per standard of care (SOC) in each of the participating sites; no medication that interacts with the pharmacokinetics (PK) of tacrolimus is allowed unless subjects who are recipients of a renal transplant at least 1 month and not more than 5 years prior to enrollment. Following screening, study visits will be conducted over a 2-week treatment period with consists of 1 week of Prograf or generic tacrolimus SOC, and 1 week of LCP-Tacro. Subjects who qualify for extended use of LCP-Tacro can continue LCP-Tacro treatment for additional 2 years. This decision will be made at the discretion of the physician and subject.

Arms: arm 1: LCP Tacro tables for once daily oral administration arm 2: Tacrolimus capsules for twice daily oral administration
Interventions: intervention 1: Prograf intervention 2: LCP-Tacro
Intervention descriptions: intervention 1: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice. intervention 2: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.

Protocol documents:
Clinical trial NCT01449747
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus Dipeptidyl peptidase IV inhibitors Glucagon-like peptide 1
Sponsor: The Catholic University of Korea
Start date: 2011-12-01; Completion date: 2015-07-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4 inhibitor

Detailed description:
Sitagliptin, a DPP-4 inhibitor was used as an incretin enhancer in clinical practice first. In clinical trials, sitagliptin showed effective control of blood glucose level in type 2 diabetes and 100 mg once daily with metformin was similar to sulfonylurea (glipizide) with metformin in lowering HbA1c. Mostly in practice, stable blood glucose levels were maintained after change of sulfonylurea to sitagliptin in type 2 diabetes treatment. However, in some cases, there were abrupt severe hyperglycemia and uncontrolled blood glucose level after drug change to sitagliptin.

Several mechanism could be considered for reduced response to DPP-4 inhibitor in some type 2 diabetes patients. Firstly, significantly reduced secretion of glucagon-like peptide 1 (GLP-1) more than expected in diabetes or functional defect of GLP-1 activity could be the mechanism of loss of GLP-1 effect irrespective of DPP-4. Secondly, mutation or functional defect of DPP-4 enzyme could not be inhibited by DPP-4 inhibitor. Thirdly, GLP-1 receptor mutation or other defect in β-cell responsiveness to GLP-1 leads to reduction of response to DPP-4 inhibitor.

Arms: arm 1: sitagliptin hypo-response patients arm 2: sitagliptin response patients
Interventions: intervention 1: Sitagliptin
Intervention descriptions: intervention 1: Sitagliptin (100mg, per oral) once a day.

Protocol documents:
Clinical trial NCT01450007
Conditions: Shoulder Injury
Keywords: Pain blockade Ropivacaine Dexamethasone
Sponsor: Mayo Clinic
Start date: 2012-05-01; Completion date: 2015-07-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.

Detailed description:

Arms: arm 1: Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline arm 2: Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml arm 3: Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
Interventions: intervention 1: Ropivacaine intervention 2: Dexamethasone intervention 3: Dexamethasone intervention 4: Normal saline intervention 5: Normal saline
Intervention descriptions: intervention 1: 25 ml ropivacaine 0.5% intervention 2: 8 mg dexamethasone (perineural) intervention 3: 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous) intervention 4: 5 ml normal saline (intravenous) intervention 5: 0.8 ml normal saline (perineural)

Protocol documents:
Clinical trial NCT01470144
Conditions: Pulmonary Arterial Hypertension
Sponsor: Actelion
Start date: 2011-06-01; Completion date: 2015-07-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.

Detailed description:

Arms: arm 1: Single arm, open-label
Interventions: intervention 1: Epoprostenol
Intervention descriptions: intervention 1: Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit

Protocol documents:
Clinical trial NCT01484691
Conditions: Asthma
Sponsor: University of California, San Francisco
Start date: 2012-01-01; Completion date: 2015-07-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a single center study of asthmatic subjects and healthy controls which will investigate mechanisms of asthma through detailed molecular analysis of airway tissues and fluids. The primary goal will be investigate the role of microRNAs in Th2-driven inflammation in asthma. The investigators hypothesize that asthma is associated with abnormal expression of miRNAs in T cells which favors differentiation into Th2-cells. The investigators further hypothesize that asthma is heterogeneous based on the presence and absence of Th2-driven inflammation and that abnormalities in T cell miRNA expression will be most prominent in a subgroup with high levels of Th2-driven inflammation (as assessed using molecular markers that the investigators have previously established). Finally, the investigators hypothesize that inhaled corticosteroids will normalize the T-cell miRNA abnormalities observed in asthma, as corticosteroids treat Th2-driven inflammation. The samples collected will also facilitate the pursuit of secondary analyses designed to investigate mechanisms of inflammation and remodeling in asthma as well as molecular phenotypes of asthma.

Detailed description:

Arms: arm 1: Healthy non-asthmatic controls who will be studied at one point in time and serve as a control group for the baseline bronchoscopy and evaluation of T-cell miRNA expression. arm 2: Steroid-naïve asthma (randomized to 8 weeks of treatment with inhaled corticosteroids). Asthmatics not on inhaled corticosteroids, randomized to inhaled budesonide, 1 puff (180mcg) twice a day for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline (before corticosteroids) and again after treatment with inhaled corticosteroids. arm 3: Steroid-naïve asthma (randomized to 8 weeks of no inhaled corticosteroid treatment). Asthmatics not on inhaled corticosteroids, randomized to no change in treatment for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline and again after 8 weeks without treatment with inhaled corticosteroids.
Interventions: intervention 1: Budesonide
Intervention descriptions: intervention 1: Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks

Protocol documents:
Clinical trial NCT01489826
Conditions: Solid Tumour
Keywords: Cancer
Sponsor: e-Therapeutics PLC
Start date: 2012-01-01; Completion date: 2015-07-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is a trial of Dexanabinol in patients with advanced solid tumours. The purposes of this protocol are to study different doses of the study drug to determine the maximum safe dose and to further understand the safety of the study drug; to understand what the body does to the study drug; to understand what the study drug does to the body and to measure any reduction in size of patients' cancer tumour(s).

Dexanabinol is a synthetic cannabinoid derivative with reduced psychotropic potential which was initially investigated as a neuroprotective agent. Because of its method of action however it is thought that it may have the effect of destroying cancer cells by reducing the level of control on networks that prevent cancer cells dying.

Detailed description:

Arms: arm 1: Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 2: Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 3: Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 4: Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 5: Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 6: Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 7: Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 8: Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 9: Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Interventions: intervention 1: Dexanabinol intervention 2: Cremophor
Intervention descriptions: intervention 1: Patients will (initially) be given a slow intravenous (i.v.) infusion of Dexanabinol over 3 hours on Days 1, 8 and 15 of a three weekly (21 day) cycle. intervention 2: Drug vehicle.

Protocol documents:
Clinical trial NCT01490866
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer Axitinib FOLFOX/Bevacizumab
Sponsor: SCRI Development Innovations, LLC
Start date: 2012-01-01; Completion date: 2015-07-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC.

Detailed description:
All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started. With approval of the Medical Monitor,patients who are having significant benefit from FOLFOX/bevacizumab may continue chemotherapy to a maximum of six 28-day cycles. During trial treatment, all patients will be assessed for response every 8 weeks (2 cycles).

Arms: arm 1: Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC. (FOLFOX is a combination of 5-Fluorouracil, Leucovorin and Oxaliplatin.)

All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started.
Interventions: intervention 1: Axitinib intervention 2: Bevacizumab intervention 3: 5-Fluorouracil intervention 4: 5-Fluorouracil intervention 5: Leucovorin intervention 6: Oxaliplatin
Intervention descriptions: intervention 1: 5-mg tablets PO BID intervention 2: 5 mg/kg Days 1 and 15; IV intervention 3: 400 mg/m2 Days 1 and 15; IV intervention 4: 2400 mg/m2 over 46-48 hours Days 1 and 15; Continuous Intravenous intervention 5: 400 mg/m2 Days 1 and 15; IV intervention 6: 85 mg/m2 Days 1 and 15; IV

Protocol documents:
Clinical trial NCT01511978
Conditions: Lambert-Eaton Myasthenic Syndrome Eaton-Lambert Myasthenic Syndrome
Keywords: Lambert-Eaton Eaton-Lambert myasthenia myasthenic LEMS LES DAP diaminopyridine 3,4-diaminopyridine 3,4-DAP
Sponsor: Jacobus Pharmaceutical
Start date: 2012-01-01; Completion date: 2015-07-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome (LEMS)-related weakness.

Detailed description:
The objectives of the study were to confirm the safety and to test the efficacy of 3,4-DAP in the treatment of LEMS-related weakness.

This was a phase 2 randomized double-blind placebo-controlled withdrawal study in subjects with known clinically active LEMS who had been on a chronic stable dose of compassionate distribution Jacobus 3,4-DAP provided through FDA-approved individual investigator-held INDs.

Arms: arm 1: Subjects continued taking their usual individualized regimen of 3,4-DAP base, 30 to 100 mg daily divided into at least 3 doses. arm 2: Subjects were tapered over 3 days from their usual individualized regimen of 3,4-DAP base (30 to 100 mg daily divided into at least 3 doses) to placebo with up to an additional 16 hours of placebo before resuming their usual pre-study regimen of 3,4-DAP base
Interventions: intervention 1: Continuous 3,4-DAP intervention 2: Taper 3,4-DAP to Placebo
Intervention descriptions: intervention 1: Subjects were maintained on their usual personal dose and schedule of 3,4-DAP base intervention 2: Subjects were tapered over 3 days from their usual regimen of 3,4-DAP base to placebo with up to an additional 16 hours of placebo before resuming their usual pre-study regimen of 3,4-DAP base

Protocol documents: