ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00462488
Conditions: Urinary Bladder Cancer Bladder Cancer Bladder Neoplasms Bladder Tumors
Sponsor: Sesen Bio, Inc.
Start date: 2007-03-01; Completion date: 2009-10-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG).

Detailed description:
A phase II study was performed to assess the efficacy and tolerability of intravesical Vicinium in patients with urothelial carcinoma in situ of the bladder. Bacillus Calmette-Guérin treatment had previously failed in all patients. A total of 46 patients were treated with Vicinium with half being administered 30mg/dose once per week for 6 weeks (cohort 1) and the other half (cohort 2) the same dose but administered once per week for 12 consecutive weeks. Disease assessments consisting of urine cytology, cystoscopy and, if indicated, biopsy were performed at 3 month intervals. Patients that were disease-free at the assessment time point were allowed to continue treatment in the maintenance phase which consisted of three weekly doses, followed by 9 weeks of no treatment. As long as the patient remained disease-free, treatment continued for a total of one year.

Arms: arm 1: Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.

If the subject had histologically confirmed disease that is stage \<T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study \[EOS\]). arm 2: Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.

If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).
Interventions: intervention 1: Vicinium
Intervention descriptions: intervention 1: Intravesical administration of Vicinium

Protocol documents:
Clinical trial NCT00475865
Conditions: Multiple Sclerosis
Keywords: MS glatiramer acetate adjunctive therapy relapses
Sponsor: Sanofi
Start date: 2007-04-01; Completion date: 2009-10-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of Glatiramer Acetate \[GA\].

The secondary objectives were:

* to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;
* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.

Detailed description:
The duration of the study period for a participant was approximatively 44 weeks broken down as follows:

* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.

'\*' Participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395.

Arms: arm 1: Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate (GA) for 24 weeks arm 2: Teriflunomide 7 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks arm 3: Teriflunomide 14 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks
Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide) intervention 3: Glatiramer Acetate (GA)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration intervention 3: Solution in prefilled syringe for subcutaneous injection

Protocol documents:
Clinical trial NCT00479765
Conditions: Glioblastoma Multiforme Brain Neoplasms
Keywords: glioblastoma multiforme recurrent Phase 1 Phase 2 Phase I Phase II brain cancer paclitaxel intracranial tumor local chemotherapy brain tumor brain cancer glioma OncoGel
Sponsor: Boston Scientific Corporation
Start date: 2007-03-01; Completion date: 2009-10-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.

The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor. Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients, and watching the patients closely for side effects before moving to the next dose level. The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing.

Detailed description:
This study is for patients with recurrent glioblastoma multiforme. Because most recurrences are in the area of the original resection, local delivery of a chemotherapeutic agent may prevent or delay additional recurrences. Paclitaxel has demonstrated activity against 9L glioma tumor lines, but has poor central nervous system penetration after intravenous administration. OncoGel is a new formulation of paclitaxel in a bioerodible gel that can be administered directly to the brain, thereby bypassing the blood-brain barrier.

Arms: arm 1: OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel
Interventions: intervention 1: OncoGel (ReGel/Paclitaxel)
Intervention descriptions: intervention 1: OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.

Protocol documents:
Clinical trial NCT00487578
Conditions: Post Traumatic Headache
Keywords: Post traumatic headache Head trauma Head injury Headache Naratriptan
Sponsor: Cady, Roger, M.D.
Start date: 2006-10-01; Completion date: 2009-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether naratriptan, a medication approved for treatment of migraine, is effective in the treatment of post traumatic headache associated with cognitive dysfunction.

Detailed description:
Naratriptan has demonstrated efficacy in relieving headache. Other studies have demonstrated that primary headaches with at least one headache feature are likely to respond to triptans. In addition, there are anecdotal reports of triptans being effective in post traumatic headaches, especially if headache features are noted in the patient's history. Further, there are several small pilot studies with triptans demonstrating a prompt improvement in headache-induced cognitive changes. Cognitive performance can be measured by the Mental Efficiency Workload Test (MEWT), a handheld Palm neuropsychological test battery that measures mental efficiency. This tool can be used to demonstrate short and long term improvement in mental status beyond that seen at baseline.

Informal observations by the protocol authors have suggested that the use of triptans on a routine basis may ameliorate the headache and associated symptomatology of post traumatic headache. Therefore, this study is undertaken to study the use of naratriptan in the treatment of post traumatic headache. Roger K. Cady, MD, serves as the sponsor. The study is funded by GlaxoSmithKline.

56 subjects with a formal diagnosis of Chronic post-traumatic headache attributed to mild head injury (IHS/ICHD-II 5.2.2) and with self-reported mild cognitive inefficiency secondary to headache will be enrolled. Subjects meeting inclusion criteria will complete a physical examination and baseline testing and be randomized 1:1 to naratriptan 2.5mg bid x 30 days or a matched placebo bid x 30 days. A daily diary will document response to treatment. Subjects will return to the clinic at Day 10 and Day 30 and complete phone contacts at Days 5, 15, 21, 32 and 90. Information will be collected throughout the study on questionnaires related to headache impact, general health, satisfaction with medication, and quality of life. Cognition will be measured using the MEWT.

Arms: arm 1: Naratriptan 2.5 mg tablet bid x 30 days arm 2: placebo matching naratriptan 2.5 mg tablet
Interventions: intervention 1: naratriptan HCl
Intervention descriptions: intervention 1: naratriptan 2.5mg tablet bid x 30 days OR matching placebo

Protocol documents:
Clinical trial NCT00487747
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2006-08-01; Completion date: 2009-10-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 180 micrograms sc weekly for 48 weeks

Protocol documents:
Clinical trial NCT00511836
Conditions: Alcohol Dependence
Keywords: alcoholism addiction alcohol detoxification
Sponsor: Alkermes, Inc.
Start date: 2007-07-01; Completion date: 2009-10-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. The study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal increases in response to alcohol-related cues.

In the double-blind portion, subjects received a single administration of study drug (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with VIVITROL 380 mg.

Detailed description:
The double-blind phase consisted of 6 visits over a 5- to 6-week period and included 2 telephone contacts and 2 functional magnetic resonance imaging (fMRI) scans.

The optional open-label extension included 2 visits approximately 1 month apart. Subjects who completed both phases participated in a total of 8 scheduled visits (including 2 fMRI scans and 2 telephone contacts) over a period of up to 14 weeks.

At screening, eligible, consenting subjects were given an Actiwatch®-Score device. They were instructed to record their alcohol craving using this device throughout the double-blind phase. The Actiwatch was programmed to beep every 3 hours ±20 minutes, thereby signaling the subjects to enter their craving or desire to use alcohol, at that exact moment, on a scale of 0 to 10 (with 0 being no craving at all and 10 being extreme craving). In addition, subjects entered any drug and/or alcohol use at the time of occurrence. The Actiwatch was not utilized in the open-label portion of the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: VIVITROL 380 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Administered via intramuscular (IM) injection once during the double-blind phase and for 2 additional injections, 4 weeks apart, during the optional open-label extension. intervention 2: Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only.

Protocol documents:
Clinical trial NCT00523705
Conditions: PMS
Keywords: premenstrual syndrome PMS PMDD treatment SSRI
Sponsor: University of Pennsylvania
Start date: 2008-02-01; Completion date: 2009-10-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.

Detailed description:
The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.

Arms: arm 1: Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. arm 2: Placebo tablets matched to drug.
Interventions: intervention 1: escitalopram intervention 2: placebo
Intervention descriptions: intervention 1: 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. intervention 2: Placebo tablets matched to drug

Protocol documents:
Clinical trial NCT00529659
Conditions: Sarcopenia
Keywords: Sarcopenia (loss of muscle mass)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-10-01; Completion date: 2009-10-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass).

Detailed description:

Arms: arm 1: MK-0773 arm 2: Placebo
Interventions: intervention 1: Comparator: MK-0773 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: MK-0773 50 mg tablets twice daily, 6 month treatment period intervention 2: Placebo tablets twice daily, 6 month treatment period

Protocol documents:
Clinical trial NCT00545571
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-10-01; Completion date: 2009-10-01
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent \[ESA\] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter \[g/dL\] for Switzerland and 10 to 12 g/dL for Austria).

Detailed description:

Arms: arm 1: Participants will receive intravenous Mircera every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: Mircera will be administered intravenously every 4 weeks for a total of 52 weeks. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.

Protocol documents:
Clinical trial NCT00547534
Conditions: Non-Hodgkin's Lymphoma
Keywords: Bortezomib Bendamustine Rituximab Relapsed Refractory Mantle Cell Indolent
Sponsor: University of Rochester
Start date: 2007-10-01; Completion date: 2009-10-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.

Detailed description:

Arms: arm 1: Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib.
Interventions: intervention 1: bortezomib intervention 2: bendamustine intervention 3: rituximab
Intervention descriptions: intervention 1: 1.3 mg/m\^2 on days 1, 4, 8, 11 intervention 2: 90 mg/m\^2 days 1 and 4 intervention 3: 375 mg/m\^2 day 1

Protocol documents:
Clinical trial NCT00548262
Conditions: Candidemia Invasive Candidiasis
Keywords: Open-label non-comparative study to evaluate short course of IV anidulafungin followed by oral voriconazole for tx of candidemia/invasive candidiasis.
Sponsor: Pfizer
Start date: 2008-02-01; Completion date: 2009-10-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Anidulafungin intervention 2: Voriconazole
Intervention descriptions: intervention 1: All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin. intervention 2: Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if \<40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if \<40 kg body weight).

Protocol documents:
Clinical trial NCT00550407
Conditions: Bipolar Disorder
Keywords: Lamotrigine Prevention of relapse or recurrence of a mood episode Bipolar I disorder
Sponsor: GlaxoSmithKline
Start date: 2007-11-01; Completion date: 2009-10-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: lamotrigine intervention 2: Placebo
Intervention descriptions: intervention 1: lamotrigine 100mg/day or 200mg/day intervention 2: placebo once daily

Protocol documents:
Clinical trial NCT00559273
Conditions: Renal Anemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2007-12-01; Completion date: 2009-10-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks. arm 2: Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta intervention 2: Darbepoetin alfa
Intervention descriptions: intervention 1: 1.2 mcg/kg SC monthly, starting dose intervention 2: 0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose

Protocol documents:
Clinical trial NCT00574236
Conditions: Metastatic Breast Cancer
Sponsor: University of Wisconsin, Madison
Start date: 2006-08-01; Completion date: 2009-10-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PS-341, doxorubicin
Intervention descriptions: intervention 1: bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle

Protocol documents: