ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00793793
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2007-09-01; Completion date: 2011-01-25
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

Detailed description:

Arms: arm 1: patient to receive 20mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 2: patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 3: patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 4: patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 5: None
Interventions: intervention 1: BI201335 intervention 2: BI201335 intervention 3: BI201335 intervention 4: BI201335 intervention 5: Placebo
Intervention descriptions: intervention 1: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 2: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 3: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 4: patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days intervention 5: None

Protocol documents:
Clinical trial NCT00798967
Conditions: Short Bowel Syndrome
Keywords: SBS short bowel syndrome TPN parenteral nutrition PN
Sponsor: Shire
Start date: 2008-11-25; Completion date: 2011-01-25
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

Detailed description:

Arms: arm 1: 0.05 mg/kg/day sc dose of teduglutide arm 2: Matching subcutaneous dose of placebo to teduglutide
Interventions: intervention 1: teduglutide intervention 2: placebo
Intervention descriptions: intervention 1: 0.05 mg/kg/day sc injection for 24 weeks intervention 2: Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks

Protocol documents:
Clinical trial NCT00853307
Conditions: Ovarian Carcinoma
Keywords: Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2009-03-23; Completion date: 2011-01-27
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in the treatment of participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.

Detailed description:
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. This study looked at the antitumor activity by response rate who would take alisertib.

The study enrolled 31 patients. Participants were categorized as per the disease state into 2 categories, refractory and resistant. Participants received:

• Alisertib 50 mg

All participants took alisertib 50 mg capsules every 12 hours each day for 7 days followed by a 14-day rest period in a 21-day cycle (up to 26 cycles).

This multi-center trial was conducted in France, Poland and the United States. The overall time to participate in this study was 12 months, unless it is determined that a participant would benefit from continued therapy beyond 12 months. Participants made multiple visits to the clinic, and were contacted up to a maximum of every 12 weeks up to 12 months after last dose of study drug for follow-up assessments.

Arms: arm 1: Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
Interventions: intervention 1: Alisertib
Intervention descriptions: intervention 1: Alisertib capsules

Protocol documents:
Clinical trial NCT00535782
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2007-10-31; Completion date: 2011-01-31
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus methotrexate.

Detailed description:

Arms: arm 1: Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks. From Week 24 to Week 104, participants received open-label TCZ 8 mg/kg every 4 weeks plus 7.5-25 mg MTX weekly. arm 2: Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks. From Week 24 to 104, participants received open-label tocilizumab (TCZ) 8 mg/kg every 4 weeks plus 7.5-25 mg MTX.
Interventions: intervention 1: Tocilizumab intervention 2: Placebo intervention 3: Methotrexate
Intervention descriptions: intervention 1: Administered by intravenous infusion, 8 mg/kg every 4 weeks. intervention 2: Placebo to tocilizumab administered by intravenous infusion every 4 weeks. intervention 3: Administered orally or parenterally, 7.5-25 mg weekly.

Protocol documents:
Clinical trial NCT00833989
Conditions: Ischaemic Attack, Transient
Sponsor: GlaxoSmithKline
Start date: 2009-07-08; Completion date: 2011-01-31
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to is to test increasing repeat doses of GSK249320 compared to placebo in patients with stroke.

Detailed description:
GSK249320 is a humanised monoclonal antibody (mAb) that binds with high specificity to myelin-associated glycoprotein (MAG) and antagonises or neutralises MAG-mediated inhibition and has been shown to improve functional recovery after stroke in pre-clinical models, possibly by promoting neuroregeneration and plasticity. The present study is the first in patients with stroke. The main aim of this study is to select tolerated doses of GSK249320 that can be used in future trials to evaluate its efficacy in improving clinical function in patients recovering from stroke. This clinical trial is designed as a placebo-controlled, single-blind, multicenter study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating repeat IV doses of GSK249320. Three sequential dose escalation cohorts (1, 5 and 15 mg/kg) are planned, with 8 patients on placebo and 8 on active in cohort 1 and 4 patients on placebo and 8 on active in cohorts 2 and 3. Each patient will receive 2 repeat IV doses 9 ± 1 days apart and assessments will extend to at least 16 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: GSK249320 intervention 2: PLACEBO
Intervention descriptions: intervention 1: I.V. infusion intervention 2: Placebo

Protocol documents:
Clinical trial NCT00893789
Conditions: Traumatic Brain Injury
Sponsor: Cephalon, Inc.
Start date: 2009-04-30; Completion date: 2011-01-31
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).

Detailed description:

Arms: arm 1: Armodafinil 50 mg/day arm 2: Armodafinil 150 mg/day arm 3: Armodafinil 250 mg/day arm 4: Placebo
Interventions: intervention 1: Armodafinil intervention 2: Armodafinil intervention 3: Armodafinil intervention 4: Placebo
Intervention descriptions: intervention 1: Armodafinil 50 mg/day intervention 2: Armodafinil 150 mg/day intervention 3: Armodafinil 250 mg/day intervention 4: Placebo

Protocol documents:
Clinical trial NCT00983437
Conditions: Traumatic Brain Injury
Sponsor: Cephalon, Inc.
Start date: 2009-08-31; Completion date: 2011-01-31
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).

Detailed description:

Arms: arm 1: Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Interventions: intervention 1: Armodafinil
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00036270
Conditions: Breast Neoplasms
Sponsor: Pfizer
Start date: 2001-08-01; Completion date: 2011-02-01
Enrollment: 9779 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exemestane (Aromasin) intervention 2: tamoxifen + exemestane
Intervention descriptions: intervention 1: exemestane, orally, 25 mg, for 5 years intervention 2: tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

Protocol documents:
Clinical trial NCT00861692
Conditions: Heparin-induced Thrombocytopenia Type II
Keywords: Argatroban heparin induced thrombocytopenia (HIT) direct thrombin inhibitor (DTI)
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-04-01; Completion date: 2011-02-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: argatroban
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00006489
Conditions: Alcoholism Alcohol Dependence Post-Traumatic Stress Disorder
Keywords: Alcoholism Alcohol Dependence Post-Traumatic Stress Disorder Naltrexone Cognitive Behavior Therapy
Sponsor: University of Pennsylvania
Start date: 2000-12-01; Completion date: 2011-02-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.

Detailed description:

Arms: arm 1: Naltrexone alone arm 2: Naltrexone with CBT for PTSD arm 3: Placebo with CBT for PTSD arm 4: Placebo alone
Interventions: intervention 1: Cognitive-Behavioral Therapy intervention 2: Naltrexone intervention 3: Placebo
Intervention descriptions: intervention 1: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week intervention 2: Daily dosing 100 mg for 24 weeks intervention 3: Pill Placebo daily dosing 24 weeks

Protocol documents:
Clinical trial NCT00087139
Conditions: Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IV Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-09-01; Completion date: 2011-02-01
Enrollment: 124 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.

Detailed description:
PRIMARY OBJECTIVE:

I. To determine the effect on percent with a 50% decrease in PSA response in patients with metastatic prostate cancer who have progressed on androgen ablation therapy and are classified into 1 of 3 separate categories:

1. Never received prior chemotherapy/cytotoxic therapy
2. Received prior taxane-based regimen
3. Received 2 prior cytotoxic chemotherapy regimens (including, but not limited to, prior taxane and anthracyclines)

SECONDARY OBJECTIVES:

I. Determine measurable disease response in patients with measurable disease treated with this drug and overall response rate.

II. Determine the toxic effects of this drug in these patients. III. Determine the duration of PSA and measurable disease response in patients treated with this drug.

IV. Determine the expression of p53, multidrug resistance protein, and Bcl-2 by immunohistochemistry in the primary tumors of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).

Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).

Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: ixabepilone
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00115804
Conditions: Juvenile Primary Fibromyalgia Syndrome (JPFS) Fibromyalgia
Keywords: Fibromyalgia Juvenile
Sponsor: University of Cincinnati
Start date: 2005-06-01; Completion date: 2011-02-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to conduct an open, pilot trial to assess the efficacy and safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).

Detailed description:
Fibromyalgia is a common condition that is often challenging to treat. It is defined by the American College of Rheumatology (ACR) as widespread pain of at least 3 months duration in combination with tenderness at 11 or more of 18 specific tender point sites on the body. The prevalence of JPFS in children and adolescents in the general population of the United States is unknown. Studies from Israel, Mexico, and Italy have estimated that the prevalence rate of JPFS in school children ranges from 1.24% to 6.20%, with girls making up the majority of cases. Information from a national registry in the United States indicates that JPFS accounts for about 7.7% of new patient diagnoses in a pediatric rheumatology setting. The mean age of onset of pediatric JPFS is 12 years. As in adults, JPFS has been diagnosed in children and adolescents using the ACR criteria. JPFS often leads to substantial morbidity and disability. For example, adolescents with JPFS reported significantly greater functional disability and greater number of school absences than those with other rheumatic diseases such as juvenile RA or lupus. The presence of high levels of pain and disability at this critical developmental stage place adolescents with JPFS at greater risk for long term social and occupational difficulties. Early diagnosis and effective intervention are therefore of critical importance.

Arms: arm 1: All eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily.
Interventions: intervention 1: Fluoxetine
Intervention descriptions: intervention 1: Fluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily

Protocol documents:
Clinical trial NCT00258310
Conditions: Head and Neck Cancer
Keywords: stage I squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the nasopharynx stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the nasopharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the oropharynx
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2003-12-01; Completion date: 2011-02-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery, radiotherapy, and/or chemotherapy.

Secondary

* Determine the time to recurrence, local-regional control, and survival rate in patients treated with this drug.
* Determine the incidence of second primary tumors in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral capecitabine once daily for 1 year in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Arms: arm 1: Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.
Interventions: intervention 1: capecitabine intervention 2: Surgery, chemotherapy and/or radiotherapy
Intervention descriptions: intervention 1: Capecitabine 1000mg/day for one year intervention 2: Surgery, chemotherapy and/or radiotherapy

Protocol documents:
Clinical trial NCT00303823
Conditions: Cervical Cancer Cervical Intraepithelial Neoplasia Grade 1 Human Papilloma Virus Infection
Sponsor: National Cancer Institute (NCI)
Start date: 2005-09-01; Completion date: 2011-02-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea extract may stop cervical cancer from forming in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. It is not yet known whether green tea extract is more effective than a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia.

Detailed description:
PRIMARY OBJECTIVES:

I. Assess the effect of green tea extract (Polyphenon E®) in patients with human papillomavirus (HPV) expression and low-grade cervical intraepithelial neoplasia (CIN 1) in a pre- and post-treatment setting.

SECONDARY OBJECTIVES:

I. Compare the toxicity of green tea extract vs placebo among patients with CIN 1.

TERTIARY OBJECTIVES:

I. Evaluate the utility of karyometry as an intermediate endpoint biomarker for cervical chemoprevention studies.

OUTLINE:

This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral green tea extract (Polyphenon E®) once daily for 16 weeks in the absence of unacceptable toxicity.

ARM II: Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed for 2 weeks.

Arms: arm 1: Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity. arm 2: Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
Interventions: intervention 1: placebo intervention 2: defined green tea catechin extract intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies

Protocol documents: