ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01454778
Conditions: Peripheral Vascular Disease
Keywords: restenosis peripheral vascular disease lower extremity ischemia claudication
Sponsor: Patrick Kelly
Start date: 2011-04-01; Completion date: 2015-04-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single, one time, limited dose infusion of Paclitaxel, that will potentially prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control group at 10 months.

Detailed description:
The investigators study consists of enrolling subjects that are already scheduled to have the blood vessels in their legs re-opened. The entire study is considered standard of care, except the administration of Paclitaxel. Subjects will be consented prior to any study related procedures and prior to procedure. Subjects that meet inclusion/exclusion and the infusion of Paclitaxel has been given, will then be enrolled in the study. After the plaque area has been treated with either angioplasty (inflation of a balloon compacting it against the artery wall), stent (a wire mesh tube that presses the plaque against the artery wall and opens the artery), and/or atherectomy(removal of plaque from the artery), Dr Kelly, Dr. Schultz, Dr, Laurich, or Dr. Santos will then use an infusion balloon (a balloon with an outer layer that has holes that allows a medication to be given) to administer the Paclitaxel. Every time the infusion balloon is blown up, a single dose of medication (Paclitaxel) will be applied to the target lesion. This will be repeated until all of the target lesions have been treated or a maximum dose of 10 mg of Paclitaxel has been given. All persons enrolled in this study will be treated with Paclitaxel. Subjects are expected to attend all follow up visits. These visits would occur even if the subject were not on the trial. Ankle-brachial index (ABI) (done by measuring blood pressure at the ankle and in the arm while a person is at rest. This test indicates if leg blockages are present) and Duplexes (An ultrasound that measures blood flow rates through the vessels. This test will indicate if leg blockages are present) will be done at the follow up visits. Both of these tests and all follow up visits are considered standard of care and will be charged to the subject or subject's insurance.

Arms: arm 1: None
Interventions: intervention 1: Paclitaxel
Intervention descriptions: intervention 1: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm\^3

Paclitaxel Dosage:

Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon\* Popliteal: 1.8 mg/inflation of balloon\* Tibial: 1.4 mg/inflation of balloon\*

* not to exceed 10mg total dose

Protocol documents:
Clinical trial NCT01486784
Conditions: Acute Myelogenous Leukemia
Keywords: equal to or greater than age 60 years non-M3 AML relapsed disease primary refractory disease not appropriate or willing candidates for aggressive therapy AML
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2011-11-01; Completion date: 2015-04-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was initially a phase I/II, open-label non-randomized study using an investigational new drug, TL32711, in patients with AML, MDS and ALL, however, the phase II portion was never initiated. This study initially targeted subjects 60 years of age and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or who are newly diagnosed and subjects 18-59 (relapsed or refractory after failing 3 prior lines of therapy), and then targeted subjects 18 years of age and older with MDS and ALL.

Detailed description:
This was initially a phase I/II, open-label, non-randomized study using an investigational new drug, TL 32711, in patients with acute myelogenous leukemia. This study targeted subjects 60 years of age and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or who are newly diagnosed and not candidates for standard induction therapy) and subjects 18-59 (relapsed or refractory after failing 3 prior lines of therapy). Subjects would receive the study drug in 4 weeks dosing periods via one of three different treatment schedules (once weekly, twice weekly or three times weekly dosing). They would receive treatment for up to 6 cycles, however treatment may have been extended at the discretion of the study doctor if felt to be in the best interest of the subject. Up to 46 subjects were to be enrolled on this study at the University of Pennsylvania, depending on the number of subjects needed in the Phase I component in order to determine the MTD. The primary objective of the Phase 1 component was to determine the safety and tolerability of TL32711, and the MTD in this patient population. The primary objective of the Phase 2 portion of this study was to further define the safety and tolerability, and provide preliminary efficacy data, however, the Phase II portion was never initiated.

Arms: arm 1: 26mg/m2/dose IV once per week x 3 weeks of 4 week cycle arm 2: 17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle arm 3: 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle arm 4: 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle arm 5: 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle arm 6: 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle
Interventions: intervention 1: Birinapant
Intervention descriptions: intervention 1: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion

Protocol documents:
Clinical trial NCT01506882
Conditions: Epilepsy Partial Onset Seizures
Sponsor: UCB Japan Co. Ltd.
Start date: 2011-12-01; Completion date: 2015-04-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.

Detailed description:

Arms: arm 1: Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1- week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day.

The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. arm 2: Unless a seizure occurs, the subjects in this arm will continue LEV 3000 mg/day for 26 weeks. Subjects in the LEV 3000 mg/day group undergo a 4-week Up-Titration Period prior to the 1-week Stabilization Period.

They receive 1000 mg/day for 2 weeks and 2000 mg/day for 2 weeks during the Up-Titration Period and LEV 3000 mg/day for 1 week during the Stabilization Period.

The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP.
Interventions: intervention 1: Levetiracetam (LEV)
Intervention descriptions: intervention 1: * Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: LEV 250 mg, LEV 500 mg
* Frequency: Twice daily
* Route of Administration: Oral use

Protocol documents:
Clinical trial NCT01524302
Conditions: Pneumonia, Bacterial Community-acquired
Keywords: pneumonia ceftaroline community-aquired
Sponsor: Gary E. Stein, Pharm.D.
Start date: 2012-02-01; Completion date: 2015-04-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.

Detailed description:

Arms: arm 1: Pharmacodynamics arm 2: Pharmacodynamics
Interventions: intervention 1: Ceftaroline intervention 2: Levofloxacin
Intervention descriptions: intervention 1: 600 mg Q12h intervention 2: 750 mg QD

Protocol documents:
Clinical trial NCT01527006
Conditions: Central Nervous System
Sponsor: Eisai Inc.
Start date: 2012-01-01; Completion date: 2015-04-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs

Detailed description:
This is a multicenter, multiple ascending dose, open-label study (Core Study) with an Extension Phase. The Core Study consisted of 2 phases, the Pretreatment Phase and the Treatment Phase. The Pretreatment Phase lasted up to 2 weeks in duration, during which participants were assessed for their eligibility to participate in the study. The Treatment Phase consisted of 3 periods: Titration (7 weeks), Maintenance (4 weeks), and Follow-up (4 weeks; only for those participants not rolling over into the Extension Phase after completing the Treatment Phase and for those participants who discontinued from the study). All subjects who completed all scheduled visits up to and including the final visit of the Treatment Phase (Core Study) were eligible to participate in the Extension Phase of the study. The Extension Phase consisted of 2 periods: Maintenance (41 weeks) and Follow-up (4 weeks).

Arms: arm 1: Age Cohort 1 ( greater than or equal to 7 to less than 12 years of age at time of consent/assent) and age Cohort 2 ( greater than or equal to 2 to less than 7 years of age).
Interventions: intervention 1: perampanel
Intervention descriptions: intervention 1: During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.

Protocol documents:
Clinical trial NCT01528345
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer HER2-, HR+ post-menopausal Locally advanced or metastatic Breast Cancer (HER2-, HR+)
Sponsor: Novartis Pharmaceuticals
Start date: 2012-04-01; Completion date: 2015-04-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy.

Patients must undergo molecular pre-screening prior to entry.

Detailed description:

Arms: arm 1: Fulvestrant in combination with the study drug Dovitinib. arm 2: Fulvestrant in combination with a placebo matching Dovitinib.
Interventions: intervention 1: Dovitinib intervention 2: Fulvestrant intervention 3: Dovitinib Placebo
Intervention descriptions: intervention 1: Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule intervention 2: Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week. intervention 3: Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule

Protocol documents:
Clinical trial NCT01578330
Conditions: Multiple Sclerosis Relapsing-Remitting
Keywords: Relapsing remitting multiple sclerosis Fingolimod FTY720
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-01; Completion date: 2015-04-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will assess the patients' satisfaction of treatment after 12 months treatment with fingolimod It also will assess the tolerability profile of fingolimod in a small population.

Detailed description:

Arms: arm 1: Patients received fingolimod 0.5 mg oral capsules daily with or without food.
Interventions: intervention 1: Fingolimod
Intervention descriptions: intervention 1: Fingolimod 0.5mg orally once a day without food.

Protocol documents:
Clinical trial NCT01585246
Conditions: Prostate Cancer
Keywords: Prostate Cancer Radiation Therapy Quality of Life Symptom Management
Sponsor: Michigan State University
Start date: 2011-10-01; Completion date: 2015-04-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to test whether Saw Palmetto, is useful in preventing or reducing the side effects for men undergoing radiation therapy for prostate cancer. Urinary symptoms will be recorded each week, as well as assessment of quality of life through: 1) Physical Well-Being 2) Social/Family Well-being 3) Emotional Well-Being, and 4) Functional Well-Being.

Detailed description:
Lower urinary tract symptoms (LUTS) affect from 75-80% of men undergoing radiation therapy (RT) for prostate cancer. The purpose of this study was to determine the feasibility, safety and efficacy of inexpensive, non-toxic herbal supplement, Saw Palmetto (SP), in treating these distressing symptoms.

The study consisted of two phases: Dose Finding phase (DFP), and Exploratory Randomized Controlled Trail (RCT) phase. In the 12 week DFP, participants were given one of three doses (SP 320 mg, SP 640mg, and SP 960 mg) using the Time-to-Event Continual Reassessment Method to determine the maximum therapeutic dose (MTD). Once the MTD was determined the RCT phase was begun, participants were allocated to receive either the predetermined MTD (960 mg) in the DFP or a placebo to obtain preliminary evidence of efficacy of SP on LUTS.

Safety data consisted of the Common Terminology for Adverse Events criteria for nausea, gastritis, and anorexia. Efficacy of the MTD was evaluated by weekly symptom data and voiding diary. A pill diary was used to ensure the intervention fidelity.

Arms: arm 1: Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose arm 2: Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg. arm 3: Patients received Soybean Oil Soft Gel as the placebo treatment
Interventions: intervention 1: Saw Palmetto intervention 2: soybean oil soft gel
Intervention descriptions: intervention 1: 1 of 3 doses of Saw Palmetto (320, 640, 960mg/day) intervention 2: placebo (soybean oil soft gel)

Protocol documents:
Clinical trial NCT01587963
Conditions: Shock
Keywords: hypovolemic or septic
Sponsor: Rutgers, The State University of New Jersey
Start date: 2013-02-01; Completion date: 2015-04-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

Detailed description:
It has been shown that the stress that occurs during trauma, infection and/or shock depletes many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to further complications. The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

Arms: arm 1: Ascorbic Acid arm 2: Ringers Lactate or Normal Saline
Interventions: intervention 1: Ascorbic Acid intervention 2: Ringers Lactate or Normal Saline
Intervention descriptions: intervention 1: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams intervention 2: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.

Protocol documents:
Clinical trial NCT01606306
Conditions: Asthma Wheezing
Keywords: Asthma Wheezing Fluticasone Montelukast Preschool-age
Sponsor: Milton S. Hershey Medical Center
Start date: 2013-02-01; Completion date: 2015-04-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The INFANT study will test whether, in preschool children 12-59 months of age with persistent asthma, the following Step 2 asthma therapies will provide similar degrees of asthma control:

1. Daily inhaled corticosteroid (ICS) treatment,
2. Daily leukotriene receptor antagonist (LTRA) treatment, and
3. As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.

Detailed description:
INFANT is a double-blind, randomized clinical trial in which all participants will receive each of the three therapies for 16 weeks by means of a cross-over study design. INFANT aims to determine whether individual children respond better to one treatment than another and, if so, whether those children can be identified by phenotypic characteristics or selected biomarkers. In this regard the INFANT study is expected to address critical gaps in current asthma management guidelines. Ultimately, the findings from this study are expected to help clarify treatment modalities for this population of young preschool children who are extremely difficult to treat.

Arms: arm 1: daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate arm 2: daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast arm 3: daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate arm 4: daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate arm 5: as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast arm 6: as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
Interventions: intervention 1: daily fluticasone propionate intervention 2: Montelukast intervention 3: as-needed fluticasone propionate
Intervention descriptions: intervention 1: Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily intervention 2: Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening intervention 3: Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms

Protocol documents:
Clinical trial NCT01606319
Conditions: Asthma Wheezing
Keywords: Asthma Wheezing Ibuprofen Acetaminophen exacerbations pain fever
Sponsor: Milton S. Hershey Medical Center
Start date: 2013-02-01; Completion date: 2015-04-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Acetaminophen Versus Ibuprofen in Children with Asthma study will test the primary hypothesis that in preschool children 12-59 months of age with persistent asthma on standardized asthma therapy, the number of asthma exacerbations requiring systemic corticosteroids will be more frequent in children randomized to receive acetaminophen as compared to those randomized to receive ibuprofen on an as needed basis for fevers and pain.

Detailed description:
AVICA is a 48-week randomized therapeutic trial involving two parallel treatment arms: acetaminophen and ibuprofen. Participating children will be randomized to receive either acetaminophen or ibuprofen administered as needed per parental decision for fever and analgesia. This study will address which is the most appropriate antipyretic-analgesic medication in young children with asthma, and will inform both clinicians and parents seeking to treat children with fever and pain. Given the high frequency of administration of these drugs, this study will have a significant impact on pediatric healthcare regardless of whether a differential effect is discovered as significant uncertainty currently exists as to whether acetaminophen use is associated with increased asthma symptoms.

Arms: arm 1: acetaminophen given as needed for pain or fever arm 2: ibuprofen given as needed for pain or fever
Interventions: intervention 1: Acetaminophen intervention 2: Ibuprofen
Intervention descriptions: intervention 1: 15 mg/kg every 6 hours as needed intervention 2: 9.4 mg/kg every 6 hours as needed

Protocol documents:
Clinical trial NCT01626456
Conditions: Schizophrenia
Sponsor: Alkermes, Inc.
Start date: 2012-06-01; Completion date: 2015-04-01
Enrollment: 478 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ALKS 9072, Low intervention 2: ALKS 9072, High
Intervention descriptions: intervention 1: IM injection, given monthly intervention 2: IM injection, given monthly

Protocol documents: