ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02230306
Conditions: Active Melanoma Brain Metastases
Sponsor: Melissa Burgess, MD
Start date: 2015-02-01; Completion date: 2016-03-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of the combination of vemurafenib with cobimetinib in patients with active melanoma brain metastases.

Detailed description:

Arms: arm 1: Vemurafenib (960 mg twice a day) will be taken on Days 1 - 28 of each 28-day treatment cycle. The first dose of vemurafenib should be taken in the morning, and the second dose should be taken in the evening. Vemurafenib can be taken with or without a meal and should be taken with a glass of water.

Cobimetinib (60 mg once a day) will be taken on Days 1 - 21 of each 28-day treatment cycle. The cobimetinib tablet should be taken at approximately the same time each day in the morning with the vemurafenib dose, but no later than 4 hours after the scheduled time. Cobimetinib can be taken with or without a meal and should never be chewed, cut, or crushed and should be taken with a glass of water.
Interventions: intervention 1: Cobimetinib intervention 2: Vemurafenib
Intervention descriptions: intervention 1: 60mg once a day; will be taken on days 1-21 of each 28 day treatment cycle; will be taken in combination with Vemurafenib; intervention 2: 960mg twice a day; 28 day treatment cycle; will be taken in combination with Cobimetinib;

Protocol documents:
Clinical trial NCT02230956
Conditions: Osteoarthritis
Sponsor: Allergan
Start date: 2014-10-01; Completion date: 2016-03-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.

Detailed description:

Arms: arm 1: OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. arm 2: OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. arm 3: Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
Interventions: intervention 1: onabotulinumtoxinA intervention 2: Normal Saline
Intervention descriptions: intervention 1: onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee. intervention 2: Normal Saline (placebo) injection into the intra-articular space of the study knee.

Protocol documents:
Clinical trial NCT02242630
Conditions: Subacromial Bursitis Shoulder Pain
Keywords: Subacromial bursitis Triamcinolone Methylprednisolone Shoulder pain
Sponsor: Keesler Air Force Base Medical Center
Start date: 2014-09-01; Completion date: 2016-03-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6 weeks after injection.

Detailed description:
Background: Subacromial bursitis is a common site for patients to report shoulder pain. In some patients it is refractory to conservative therapies such as physical therapy, acetaminophen, or NSAIDs. Subacromial injection of a corticosteroid can be used to improve shoulder pain in subacromial bursitis, however, there are few well done clinical trials guiding which type of corticosteroid and the dose that would be maximally effective and with the least amount of side effects.

Methods: Our hypothesis is that both Methylprednisolone and Triamcinolone are equipotent but that 20 mg provides less relief that 40 mg injected. Subjects will be enrolled in this trial which lasts 6 weeks. Subjects will be randomized to 40 mg of methylprednisolone, 20 mg of methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. No placebo will be used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid injection.

Outcomes: Primary outcome with be the improvement in a functional measure of the shoulder, the QuickDASH ®, at 6 weeks. Secondary outcomes will be improvement in reported pain (visual analogue scale) at 6 weeks and adverse events at all time points. Data will be collected in person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6 weeks).

Arms: arm 1: Methylprednisolone, 20 mg, will be injected arm 2: Methylprednisolone, 40 mg, will be injected arm 3: Triamcinolone, 20 mg, will be injected arm 4: Triamcinolone, 40 mg, will be injected
Interventions: intervention 1: Methylprednisolone, 20 mg intervention 2: Methylprednisolone, 40 mg intervention 3: Triamcinolone, 20 mg intervention 4: Triamcinolone, 40 mg
Intervention descriptions: intervention 1: Compared with intrabursal triamcinolone intervention 2: Compared with intrabursal triamcinolone intervention 3: Compared with methylprednisolone intervention 4: Compared with methylprednisolone

Protocol documents:
Clinical trial NCT02279082
Conditions: Acute Migraine
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2014-09-01; Completion date: 2016-03-01
Enrollment: 167 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines

Detailed description:

Arms: arm 1: DFN-02 to be taken during migraine attack
Interventions: intervention 1: DFN-02
Intervention descriptions: intervention 1: Active Experimental Drug

Protocol documents:
Clinical trial NCT02291016
Conditions: COPD Exacerbation
Keywords: COPD chronic obstructive pulmonary disease
Sponsor: University of Tennessee Graduate School of Medicine
Start date: 2015-02-01; Completion date: 2016-03-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.

Detailed description:

Arms: arm 1: Group A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2.

Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2. arm 2: Group B: Received Formoterol 20 µg (solution form) via nebulizer and placebo via a DPI at treatment visit #1, and Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2.

Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
Interventions: intervention 1: Formoterol intervention 2: Placebo
Intervention descriptions: intervention 1: Comparison of dosage administered via a nebulizer versus dosage administered via a dry powder inhaler. 12 µg Formoterol with the dry powder inhaler and 20 µg (solution form) of Formoterol with the nebulizer. Patients will receive formoterol and placebo at both study visit #1 and visit #2. intervention 2: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.

Protocol documents:
Clinical trial NCT02303184
Conditions: Macular Edema Retinal Vein Occlusion
Keywords: RVO ME Central Subfield Thickness OCT optical coherence tomography cystoid macular edema subretinal fluid Eylea aflibercept anti-VEGF
Sponsor: Clearside Biomedical, Inc.
Start date: 2015-01-01; Completion date: 2016-03-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).

Detailed description:
A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion

Arms: arm 1: Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept arm 2: Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
Interventions: intervention 1: 4 mg CLS-TA intervention 2: Sham intervention 3: IVT aflibercept
Intervention descriptions: intervention 1: 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) intervention 2: suprachoroidal sham procedure intervention 3: 2 mg intravitreal injection of aflibercept

Protocol documents:
Clinical trial NCT02321436
Conditions: Stroke Upper Limb Spasticity
Sponsor: Ipsen
Start date: 2014-12-01; Completion date: 2016-03-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic spasticity.

Detailed description:

Arms: arm 1: Dysport® 500U intramuscular injection arm 2: Placebo intramuscular injection
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb. intervention 2: Placebo administered intramuscularly in the targeted upper limb.

Protocol documents:
Clinical trial NCT02332902
Conditions: Neurofibromatosis 1
Keywords: Neurofibroma NF-1 Everolimus mTOR inhibitor
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2015-02-01; Completion date: 2016-03-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is evaluating the use of oral Everolimus to determine if there is a reduction in the size of the disfiguring cutaneous lesions in patients with Neurofibromatosis 1 over a 6 month period. The evaluation will be done by 3D photography measuring volume with the LIFEVIZ Micro system.

Detailed description:
Qualifying subjects will have a diagnosis of Neurofibromatosis 1 and have disfiguring cutaneous lesions that can be measured by photography. The subjects will have photographs of the target lesions,biopsies of the lesions,and safety blood laboratory tests at 3 time points (baseline, 3 months and 6 months which is end of treatment). Everolimus will be taken orally for 6 months. Subjects will visit the clinic monthly for an exam and adverse event evaluation. Laboratory testing will be done at these visits if determined necessary by the PI.

Arms: arm 1: This is a single arm intervention using Everolimus
Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2 week intervals to attain a trough concentration of 5-15 ng/ml

Protocol documents:
Clinical trial NCT02336425
Conditions: Asthma
Keywords: Asthma
Sponsor: Novartis Pharmaceuticals
Start date: 2015-09-01; Completion date: 2016-03-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

Detailed description:

Arms: arm 1: QGE031 240 mg subcutaneous injection every 4 weeks arm 2: QGE031 72 mg subcutaneous injection every 4 weeks arm 3: QGE031 24 mg subcutaneous injection every 4 weeks arm 4: Placebo subcutaneous injection every 4 weeks
Interventions: intervention 1: QGE031 intervention 2: Placebo
Intervention descriptions: intervention 1: QGE031 120 mg per 1 mL liquid in vial intervention 2: Placebo to QGE031 0 mg per 1 mL liquid in vial

Protocol documents:
Clinical trial NCT02345460
Conditions: Pancreatic Adenocarcinoma Poorly Differentiated Malignant Neoplasm Resectable Pancreatic Cancer Stage IA Pancreatic Cancer Stage IB Pancreatic Cancer Stage IIA Pancreatic Cancer Stage IIB Pancreatic Cancer Stage III Pancreatic Cancer Undifferentiated Pancreatic Carcinoma
Sponsor: Case Comprehensive Cancer Center
Start date: 2015-09-01; Completion date: 2016-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well combination chemotherapy works in treating patients with pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine feasibility of preoperative FOLFIRINOX for resectable pancreatic adenocarcinoma.

SECONDARY OBJECTIVES:

I. To determine safety and toxicity of preoperative FOLFIRINOX. II. To determine response rate. III. To determine proportion achieving major pathologic response - per College of American Pathologists (CAP) criteria.

IV. To determine proportion achieving R0 resection. V. To determine perioperative (30-day) mortality. VI. To determine the role of cancer antigen (CA)19.9 as potential prognostic and/or predictive biomarker.

VII. To determine progression-free survival. VIII. To determine overall survival.

OUTLINE:

Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride intravenously (IV) over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Arms: arm 1: Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Irinotecan Hydrochloride intervention 2: Oxaliplatin intervention 3: Leucovorin Calcium intervention 4: Fluorouracil intervention 5: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT02347072
Conditions: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2015-02-01; Completion date: 2016-03-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.

Detailed description:

Arms: arm 1: Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) arm 2: Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol arm 3: Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)
Interventions: intervention 1: GFF MDI (PT003) intervention 2: Placebo MDI intervention 3: Spiriva® Respimat® (Tiotropium Bromide)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Protocol documents:
Clinical trial NCT02351505
Conditions: Recurrent Small Cell Lung Carcinoma
Keywords: Small Cell Lung Cancer
Sponsor: Erin Bertino
Start date: 2015-05-01; Completion date: 2016-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well selinexor work in treating patients with small-cell lung cancer that has returned after a period of improvement. One specific way cancer cells continue to grow is by getting rid of certain proteins called "tumor suppressor proteins: that would normally cause cancer cells to die. Selinexor works by trapping "tumor suppressing proteins" within the cell and may cause the cancer cells to die or stop growing.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the efficacy of single agent selinexor as measured by progression free survival (PFS) in patients with relapsed chemotherapy-sensitive small cell lung cancer.

SECONDARY OBJECTIVES:

I. To evaluate the objective tumor response rate and disease control rate as determined by radiographic response.

II. To evaluate the overall survival (OS) in patients with relapsed small cell lung cancer.

III. To evaluate safety and tolerability of single agent selinexor in these patient populations.

IV. Comparison between each patient's time to progression (TTP) on selinexor with the TTP of his/her previous therapy(ies).

V. To evaluate correlative endpoints including tumor biopsy and analysis of secreted factors, leukocyte ribonucleic acid (RNA) analysis.

TERTIARY OBJECTIVES:

I. Analysis of secreted factors (nerve growth factor \[NGF\], brain-derived neurotrophic factor \[BDNF\]).

II. Tumor biopsy (baseline and cycle 2).

OUTLINE:

Patients receive selinexor orally (PO) twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 1 year, and then every 6 months thereafter.

Arms: arm 1: Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Selinexor intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT02374320
Conditions: CREST Syndrome Peripheral Vascular Disease Raynaud Disease Scleroderma, Diffuse
Sponsor: Jose Soberon, MD
Start date: 2014-11-01; Completion date: 2016-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.

Detailed description:

Arms: arm 1: 20 mL liposomal bupivacaine injected once
Interventions: intervention 1: liposomal bupivacaine
Intervention descriptions: intervention 1: injected as an axillary block

Protocol documents:
Clinical trial NCT02392208
Conditions: End-Stage Renal Disease Stage 5 Chronic Kidney Disease
Keywords: telavancin end-stage renal disease ESRD pharmacokinetics hemodialysis chronic kidney disease CKD dialysis Vibativ
Sponsor: University of Michigan
Start date: 2015-07-01; Completion date: 2016-03-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an increased risk for developing bloodstream infections. Vancomycin is traditionally used as first-line therapy for treating these infections, but the emergence of less-susceptible bacterial strains necessitates the consideration of alternative antibiotic therapy. Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing recommendations for telavancin are available for patients with normal kidney function, there are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic study is needed to characterize the pharmacokinetic parameters of telavancin in these patients to determine the extent of drug removal by hemodialysis and to establish dosing recommendations for CKD5 patients on maintenance hemodialysis.

Detailed description:

Arms: arm 1: Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session. arm 2: Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.
Interventions: intervention 1: Telavancin intervention 2: Pharmacokinetic Blood Sampling
Intervention descriptions: intervention 1: A single 5 mg/kg dose of telavancin is administered intravenously (IV). intervention 2: Blood samples are collected to assess telavancin plasma concentrations.

Protocol documents: