ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01204255
Conditions: Healthy
Keywords: healthy, no evidence of disease
Sponsor: Virginia Commonwealth University
Start date: 2010-11-15; Completion date: 2011-05-17
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.

Detailed description:
OBJECTIVES:I. To study the absorption of the three components in the topical ABH gel in 10 healthy volunteers, and determine if there are any adverse effects. OUTLINE: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. After completion of study treatment, patients are followed up for 5 hours.

Arms: arm 1: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Interventions: intervention 1: lorazepam intervention 2: diphenhydramine hydrochloride intervention 3: haloperidol intervention 4: questionnaire administration intervention 5: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given topically intervention 2: Given topically intervention 3: Given topically intervention 4: Ancillary studies intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT01220024
Conditions: Herniorrhaphy Postoperative Pain Inguinal Hernia
Sponsor: Innocoll
Start date: 2010-12-02; Completion date: 2011-05-18
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Detailed description:
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

This study will assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Arms: arm 1: collagen sponges arm 2: Placebo collagen sponges
Interventions: intervention 1: Bupivacaine Collagen Sponge intervention 2: Placebo collagen Sponge
Intervention descriptions: intervention 1: Drug: Bupivacaine Collagen Sponge intervention 2: Drug: Placebo Collagen Sponge

Protocol documents:
Clinical trial NCT00665652
Conditions: Neuropathy Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
Keywords: Neuropathy Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS) MGUS
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2008-04-01; Completion date: 2011-05-19
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®), on neuropathy (damage to the nerves that affect feelings and strength) associated with Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS).

Detailed description:
Screening:

All subjects eligible for screening must sign an informed consent for the study prior to any study related procedures.

Study Design:

This is an open-label, single-institutional clinical study of lenalidomide as a treatment for MGUS associated neuropathy. Eligible patients will be followed for 28 days before starting study drug. Subjects who remain eligible during the 28 day pretreatment period will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles. All patients on treatment will be followed and will be included in the intention to treat group. Patients will be evaluated every three months with the TNS. On-treatment patients must come to clinic at least monthly for the first 3 cycles, and then can come as per the schedule of study assessments only if they are on a stable dose of lenalidomide for at least one cycle. Subjects will be enrolled in the study for up to 14 months.

Lenalidomide administration:

Lenalidomide is an oral medication that will be taken at approximately the same time each day with or without food.

Lenalidomide capsules should be swallowed whole, and should not be broken, chewed or opened.

If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up.

Patients who take more than the prescribed dose of lenalidomide should be instructed to seek emergency medical care if needed and contact study staff immediately.

Dosing Regimen:

The planned dose of lenalidomide for investigation is 25 mg/day, orally on days 1-21 followed by 7 days rest (28 day cycle). Dosing will be in the morning at approximately the same time each day. The planned dose is: Plavix 75mg/day or aspirin 325mg/day.

Subjects experiencing adverse events may need study treatment modifications

Arms: arm 1: None
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.

Protocol documents:
Clinical trial NCT00572234
Conditions: Methamphetamine Use Disorder
Keywords: Methamphetamine Bupropion SR (Sustained Release)
Sponsor: University of Nebraska
Start date: 2007-08-31; Completion date: 2011-05-20
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Methamphetamine dependence is a significant drug use disorder in the Midwest. While a number of psychosocial and pharmacological treatments have been studied, no specific treatments for methamphetamine have been identified. This study is a collaborative pre-clinical and clinical partnership examining bupropion in the treatment of methamphetamine dependence.

Detailed description:
Nearly 40% of adults seeking substance use disorders (SUD) treatment in Nebraska report methamphetamine is their drug of choice. In preliminary studies examining bupropion in methamphetamine use, it was well tolerated, reduced craving for methamphetamine and reduced methamphetamine related euphoria. Investigators at the University of Nebraska Medical Center and the University of Nebraska-Lincoln have initiated studies examining bupropion in animals and humans as a potential intervention in addictive disorders. Pre-clinical studies in the Co-Investigator's laboratory were the first to demonstrate the potential utility of bupropion as a pharmacotherapy for methamphetamine use disorders (MUD) while the Principal Investigator studied bupropion as a smoking cessation aid in alcoholics.

The primary goal of this study is to establish an interdisciplinary and translational collaboration to test bupropion in persons in treatment for methamphetamine dependence and to inform pre-clinical studies so as to enhance their practical applicability to clinical settings. The pilot clinical study will examine the treatment effect and safety of a 12 week course of bupropion in persons with methamphetamine use disorder. Concurrently, we will examine the efficacy of bupropion on methamphetamine self-administration in animal models which better simulates clinical approaches.

Arms: arm 1: receiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day) arm 2: Not receiving bupropion
Interventions: intervention 1: bupropion SR
Intervention descriptions: intervention 1: 12 week course of bupropion SR 150 mg, BID

Protocol documents:
Clinical trial NCT01010542
Conditions: Plaque Psoriasis
Keywords: Single dose psoriasis study
Sponsor: Pfizer
Start date: 2009-12-01; Completion date: 2011-05-20
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this research study is to evaluate the safety and tolerability of ILV-095 when it is given to individuals with moderate to severe chronic plaque psoriasis. Another purpose of the study is to observe how the drug enters the blood and tissues over time, how the body breaks down the drug and whether or not the body will develop an immune reaction (sensitivity) to the drug.

Detailed description:
B1991002 study is a phase 1 adaptive design study which terminated on 14Mar2011. Regular analyzes of psoriasis assessments conducted per the statistical plan indicate that even if every patient enrolled for the rest of the study respond (up to 23 additional subjects), the study can not meet its primary efficacy endpoint. Pfizer Inc. has terminated the trial and clinical team is asking all clinical investigators to continue collecting safety, pharmacokinetics and pharmacodynamics data until the last subject last visit for all subjects who received test article. Last Subject Last Visit occurred 20May2011.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ILV-095 300 mg in a 4 to 1 ratio intervention 2: ILV-095 300 mg in a 4 to 1 ratio
Intervention descriptions: intervention 1: Single dose of ILV-095 300 mg intervention 2: Single dose of Placebo

Protocol documents:
Clinical trial NCT00901303
Conditions: Hodgkin's Lymphoma
Sponsor: Weill Medical College of Cornell University
Start date: 2008-10-01; Completion date: 2011-05-23
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to determine the progression-free survival \[PFS\] at 36 months for patients with Hodgkin lymphoma who achieve a complete metabolic response as demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) who undergo abbreviated ABVD chemotherapy (3 cycles).

Detailed description:
The proposed study is based on the repeated demonstration that patients with Hodgkin lymphoma who attain a negative PET scan early in therapy (after one or 2 cycles of chemotherapy) have a uniformly excellent outcome, with long term disease free survival of 90-95%. We propose to abbreviate chemotherapy in those patients showing a complete metabolic response as measured by FDG-PET after one cycle of ABVD. These patients will undergo two more cycles of ABVD chemotherapy, for a total of 3 cycles. Those patients failing to achieve a complete metabolic response as demonstrated by residual FDG avidity will go off study and be treated as per their primary treating physician.

Arms: arm 1: Group A arm 2: Group B
Interventions: intervention 1: ABVD chemotherapy
Intervention descriptions: intervention 1: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle

Protocol documents:
Clinical trial NCT00412984
Conditions: Atrial Fibrillation Atrial Flutter
Sponsor: Bristol-Myers Squibb
Start date: 2006-12-31; Completion date: 2011-05-25
Enrollment: 20976 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: warfarin intervention 2: apixaban
Intervention descriptions: intervention 1: Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0) intervention 2: Oral tablets, 5.0 mg or 2.5 mg, twice daily

Protocol documents:
Clinical trial NCT00472420
Conditions: Mantle Cell Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2007-06-27; Completion date: 2011-05-25
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: First line chemotherapy
Intervention descriptions: intervention 1: 375mg/m2 iv every 3 weeks intervention 2: As prescribed

Protocol documents:
Clinical trial NCT00430352
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2006-09-04; Completion date: 2011-05-26
Enrollment: 545 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 375mg/m2 iv every 8 weeks

Protocol documents:
Clinical trial NCT00779584
Conditions: Hodgkin Disease Lymphoma, Non-Hodgkin Neoplasms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-17; Completion date: 2011-05-28
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study of MK-8776 (SCH 900776) will evaluate its safety and tolerability when given as monotherapy or in combination with gemcitabine to participants with advanced solid tumors or lymphoma. Participants will be enrolled in cohorts that will receive sequentially higher doses of MK-8776 in combination with standard doses of gemcitabine The recommended combination doses for a Phase 2 trial (combination-RP2D) will be determined based on safety and biological activity. Up to 10 to 15 additional participants may be studied at the combination-RP2D.

Detailed description:

Arms: arm 1: Participants received MK-8776 10 mg/m\^2 given as monotherapy as an intravenous (IV) infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 2: Participants received MK-8776 20 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 3: Participants received MK-8776 40 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 4: Participants received MK-8776 80 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 5: Participants received MK-8776 112 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 6: Participants received MK-8776 80 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 7: Participants received MK-8776 112 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 8: Participants received MK-8776 150 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 9: Participants received MK-8776 200 mg given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
Interventions: intervention 1: MK-8776 intervention 2: Gemcitabine
Intervention descriptions: intervention 1: IV infusion intervention 2: IV infusion

Protocol documents:
Clinical trial NCT01090492
Conditions: Raynaud's Disease Peripheral Vascular Disease
Keywords: Raynaud's phenomenon vasospasm scleroderma systemic sclerosis CREST phosphodiesterase inhibitor
Sponsor: Pfizer
Start date: 2010-08-04; Completion date: 2011-05-31
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: PF-00489791 intervention 2: PF-00489791 intervention 3: PF-00489791 intervention 4: PF-00489791 intervention 5: PF-00489791 intervention 6: PF-00489791 intervention 7: PF-00489791 intervention 8: PF-00489791
Intervention descriptions: intervention 1: Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period intervention 2: Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period intervention 3: Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period intervention 4: Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period intervention 5: Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period intervention 6: Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period intervention 7: Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period intervention 8: Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period

Protocol documents:
Clinical trial NCT01092780
Conditions: Apnea, Sleep
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-05-26; Completion date: 2011-05-31
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy. The goal of this study is to determine the effect of MK-7288 after single dose administration on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests, and on driving performance as measured by standard deviation of lane position in simulated driving (country vigilance driving).

Detailed description:

Arms: arm 1: Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. arm 2: Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. arm 3: Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. arm 4: Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
Interventions: intervention 1: MK-7288 intervention 2: Placebo to MK-7288 intervention 3: Modafinil intervention 4: Placebo to modafinil
Intervention descriptions: intervention 1: one or two 10 mg capsules, orally, single dose intervention 2: one or two capsules, orally, single dose intervention 3: two 100 mg tablets, orally, single dose intervention 4: two 100 mg tablets, orally, single dose

Protocol documents:
Clinical trial NCT00435409
Conditions: Breast Neoplasms
Sponsor: Pfizer
Start date: 2007-02-01; Completion date: 2011-06-01
Enrollment: 442 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sunitinib + Capecitabine intervention 2: Capecitabine
Intervention descriptions: intervention 1: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.

Capecitabine administered orally at a starting dose of 2000 mg/m\^2 per day \[1000 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. intervention 2: Capecitabine administered orally at a starting dose of 2500 mg/m\^2 per day \[1250 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.

Protocol documents: