ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00530218
Conditions: Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Leukemia Lymphoma Multiple Myeloma MDS Myelodysplastic/Myeloproliferative Diseases
Sponsor: City of Hope Medical Center
Start date: 1999-03-01; Completion date: 2010-02-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by infusion and then by mouth may be effective treatment for cytomegalovirus that has become active after donor bone marrow transplant.

PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth works in treating patients with cytomegalovirus after donor bone marrow transplant.

Detailed description:
OBJECTIVES:

* To determine the feasibility of using oral ganciclovir (GCV) following induction with intravenous GCV in the setting of cytomegalovirus (CMV) reactivation after bone marrow transplantation.

OUTLINE: Blood cultures for cytomegalovirus (CMV) are obtained periodically after the planned bone marrow transplantation (BMT). Patients showing reactivation of CMV receive induction ganciclovir (GCV) IV twice a day on days 1-7. Patients then receive maintenance oral GCV three times a day for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for pharmacokinetic studies.

Arms: arm 1: Ganciclovir IV 5 mg/kg/bid x 7 days followed by Ganciclovir Oral 1000 mg tid 7 days per week x 5 weeks
Interventions: intervention 1: Ganciclovir
Intervention descriptions: intervention 1: Following the first CMV-positive blood culture on day 21 or later, or the first two consecutive CMV-positive PCR tests on day 21 or later, 5mg/kg/bid x 7 days of Ganciclovir is given intravenously, followed by oral Ganciclovir 1000 mg tid 7 days per week x 5 weeks

Protocol documents:
Clinical trial NCT00535392
Conditions: Epilepsy
Keywords: Epilepsy Child Levetiracetam Keppra® Infusion Intravenous
Sponsor: UCB Pharma
Start date: 2007-09-01; Completion date: 2010-02-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16 years.

Detailed description:
The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (4 to 16 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.

The evaluation period was to be considered as one complete set of 4 Pharmacokinetic (PK) samples for a maximum of 4 days;

* For children already taking levetiracetam oral tablets or oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose. The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.
* For children not taking levetiracetam oral tablets or oral solution prior to entering the study:

  * If weight \< 50 kg: dose of levetiracetam intravenous (LEV IV) dose will be calculated on the basis of their weight at 20 mg/kg/day (i.e. 10 mg/kg twice daily).
  * If weight ≥ 50 kg: dose of levetiracetam intravenous (LEV IV) will be 1000 mg/day (i.e. 500 mg twice daily).

However, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day.

Subjects were hospitalized for the duration of the levetiracetam IV treatment.

Arms: arm 1: None
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

Dosage for subjects not on levetiracetam at study entry was based on weight: if \<50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).

Protocol documents:
Clinical trial NCT00535847
Conditions: Hepatitis C
Keywords: Genotype 1
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2007-10-01; Completion date: 2010-02-01
Enrollment: 117 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Detailed description:

Arms: arm 1: Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks. arm 2: Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. arm 3: Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.
Interventions: intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated interferon alfa 2a
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Solution for Injection

Protocol documents:
Clinical trial NCT00537082
Conditions: Multiple Sclerosis
Keywords: FTY720, MS
Sponsor: Novartis
Start date: 2007-09-01; Completion date: 2010-02-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)

Detailed description:

Arms: arm 1: FTY720 arm 2: FTY720 arm 3: None
Interventions: intervention 1: FTY720 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally once daily for 6 months intervention 2: Administered orally once daily for 6 months

Protocol documents:
Clinical trial NCT00541346
Conditions: Autism Attention Deficit Hyperactivity Disorder
Keywords: Autism Autism Spectrum Disorders ADHD
Sponsor: University of Oklahoma
Start date: 2007-09-01; Completion date: 2010-02-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed.

The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.

Detailed description:
The design will be an open-label trial of eight weeks duration with 20 children with Autism co-morbid for ADHD. The subjects will receive 7 days of 10 mg of Daytrana. The children will be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is complete. After each week of treatment, response will be reassessed and the dose will be increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which case, the dose will be reduced to the previous dose or the patch wear time may be revised.

Arms: arm 1: 10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage
Interventions: intervention 1: Methylphenidate Transdermal System
Intervention descriptions: intervention 1: 10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage

Protocol documents:
Clinical trial NCT00543101
Conditions: HIV Infections
Keywords: HIV/AIDS darunavir Protease inhibitors Dual boosted Treatment experienced
Sponsor: Community Research Initiative of New England
Start date: 2007-10-01; Completion date: 2010-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate patients who have achieved virologic suppression (\< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic suppression (% \< 50 c/mL) for 24 weeks.

Detailed description:
The purpose of this study is to determine if patients who have achieved virologic suppression (\< 400 copies/mL) on any dual PI combination, can substitute both PIs with the single boosted PI darunavir given 600/100 rtv bid and maintain comparable virologic suppression (% \< 50 c/mL) for 24 weeks. Randomized, non-blinded, multicenter, 48 week, controlled trial to assess the non-inferiority of substituting DRV/r for a dual boosted PI combination in patients with stable virologic suppression on a regimen containing a dual boosted PI combination plus at least one additional FDA-licensed antiretroviral agent from another class. Participants will be randomized (1:1) to one of the included treatment arms.

Arms: arm 1: Switch to DRV/r at a dose of 600/100 BID for 48 weeks arm 2: Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (\< 400 copies/ml) for the first 24-weeks of the study and are followed for an additional 24 weeks
Interventions: intervention 1: Darunavir (DRV/r) intervention 2: continue on current dual boosted PI
Intervention descriptions: intervention 1: Switch to DRV/r at a dose of 600/100 BID for 48 weeks intervention 2: Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (\< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks

Protocol documents:
Clinical trial NCT00543855
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: Lewy Body Disease Dementia Clinical Trial Phase II E2020 donepezil hydrochloride
Sponsor: Eisai Co., Ltd.
Start date: 2007-11-01; Completion date: 2010-02-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: 3 mg Donepezil hydrochloride intervention 2: 5 mg Donepezil hydrochloride intervention 3: 10 mg Donepezil hydrochloride intervention 4: Placebo
Intervention descriptions: intervention 1: Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast. intervention 2: Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks). intervention 3: Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks). intervention 4: Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Protocol documents:
Clinical trial NCT00575185
Conditions: Infectious Mononucleosis
Keywords: Mono Mononucleosis Epstein-Barr virus
Sponsor: University of Minnesota
Start date: 2007-11-01; Completion date: 2010-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized, placebo-controlled, double-blind single-center proof of concept study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21 days in subjects with infectious mononucleosis documented to be caused by primary EBV infection. Otherwise healthy subjects (≥15 years old) referred to us with a clinical diagnosis of primary infectious mononucleosis will be screened and those with laboratory-confirmed primary EBV infection will be enrolled.

Detailed description:
Subjects will be seen 2 times a week for 3 weeks and then weekly for 3 weeks. Clinical findings, clinical lab tests, EBV viral loads, and EBV antibody titers will be obtained at each clinic visit.

Arms: arm 1: Valomaciclovir 2 grams orally twice daily for 21 days arm 2: placebo 2 tablets twice daily for 21 days
Interventions: intervention 1: Valomaciclovir intervention 2: placebo
Intervention descriptions: intervention 1: 4 grams orally of valomaciclovir (2 grams BID) for 21 days. intervention 2: Placebo tablets orally twice daily for 21 days.

Protocol documents:
Clinical trial NCT00581061
Conditions: Incontinence
Keywords: Incontinence Robotic Prostatectomy
Sponsor: University of California, Irvine
Start date: 2008-06-01; Completion date: 2010-02-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men. Radical prostatectomy is one of the treatment options available for organ-confined disease. Over 100,000 radical prostatectomies cases (total removal of the cancerous prostate by surgery) are performed in the United States yearly. Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life (QOL) scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day. Many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients symptoms may persist for longer periods.

Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability results in excess contractions of the urinary bladder ('urgency to urinate'), and can result in the feeling of needing to urinate more frequently. Consistent with this hypothesis of detrusor muscle instability, men with postoperative dribbling had more complaints with urgency, frequency and bother scores when queried with validated questionnaires. We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patient's dribbling of urine.

By treating the bladder muscle instability, we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate. This pilot study will assess the statistical requirements for the number of subjects needed for a fully 'powered' randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients' quality of urinary life and improve postoperative urinary incontinence after surgery.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Vesicare
Intervention descriptions: intervention 1: Vesicare will be taken daily for one or three months, depending on symptoms of subject.

Protocol documents:
Clinical trial NCT00619229
Conditions: Macular Degeneration
Keywords: Alprostadil prostaglandin E1 Prostavasin® macular degeneration
Sponsor: UCB Pharma
Start date: 2006-07-01; Completion date: 2010-02-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration

Detailed description:
Results of the planned interim analysis indicated that the number of originally planned patients were not sufficient to reach statistical significance in the primary end point. Instead of increasing the sample size accordingly, it was decided to terminate the study and plan future proceedings based on a careful analysis of the unblinded results.

Arms: arm 1: Alprostadil arm 2: Placebo
Interventions: intervention 1: Alprostadil (prostaglandin E1) intervention 2: Placebo
Intervention descriptions: intervention 1: Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days. intervention 2: Placebo/d i.v. for 15 days

Protocol documents:
Clinical trial NCT00620750
Conditions: Alcohol Dependence
Keywords: Alcohol dependence
Sponsor: NYU Langone Health
Start date: 2007-07-01; Completion date: 2010-02-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this United States Food and Drug Administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Extended release injectable naltrexone (Vivitrol)
Intervention descriptions: intervention 1: Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.

Protocol documents:
Clinical trial NCT00626028
Conditions: Idiopathic Pulmonary Arterial Hypertension Cardiomyopathy
Keywords: Pulmonary Vasculature Nitric Oxide INOmax® Acute Lung Injury Pulmonary Vasodilator Testing Idiopathic Pulmonary Arterial Hypertension Congenital Heart Disease reversible pulmonary hypertension vasoreactivity Congenital Heart Disease with Pulmonary Hypertension
Sponsor: Mallinckrodt
Start date: 2004-09-01; Completion date: 2010-02-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.

Detailed description:

Arms: arm 1: 10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1. arm 2: 10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
Interventions: intervention 1: Nitric Oxide for inhalation intervention 2: Oxygen intervention 3: Nitric Oxide plus Oxygen
Intervention descriptions: intervention 1: Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system intervention 2: 100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system intervention 3: Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system

Protocol documents: