ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00101413
Conditions: Cancer Carcinoma, Non-Small Cell Lung
Keywords: NSCLC
Sponsor: Bayer
Start date: 2004-04-01; Completion date: 2008-04-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer.

* If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer.
* If BAY43-9006 helps to slow the worsening of non-small cell lung cancer.
* If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.

Detailed description:
In addition to the key secondary outcome parameters several potential biomarkers were evaluated as exploratory parameters.

Issues on safety are addressed in the Adverse Event section.

The following acronyms and abbreviations were used in the Adverse Event section and Limitations and Caveats section:

* gastrointestinal (GI)
* not otherwise specified (NOS)
* central nervous system (CNS)
* National Cancer Institute Common Terminology Criteria (NCI-CTC)
* Medical Dictionary for Regulatory Activities (MedDRA)
* System Organ Class (SOC)
* interim analysis (IA)

Arms: arm 1: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006)
Intervention descriptions: intervention 1: BAY43-9006 400 mg bid X 28 day cycles \[Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation.

Protocol documents:
Clinical trial NCT00105586
Conditions: Anxiety Disorders Generalized Anxiety Disorder
Keywords: Anxiety Elderly Aged Serotonin Reuptake Inhibitors SSRI SERT
Sponsor: University of Pittsburgh
Start date: 2004-12-01; Completion date: 2008-04-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD in elderly individuals.

Detailed description:
GAD is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. GAD is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. Serotonin is a neurotransmitter that helps regulate mood and emotions; increased levels of serotonin have been shown to reduce anxiety. Standard treatment for GAD typically involves selective serotonin reuptake inhibitors (SSRIs), drugs that reduce serotonin re-entry into nerve cells. Escitalopram is an SSRI that is well tolerated and highly specific for the serotonin transporter (SERT). The primary aim of this study is to examine the efficacy of escitalopram in reducing anxiety symptoms among elderly GAD patients. Additional aims include examining the efficacy of escitalopram for improving function, quality of life, and neuropsychological functioning, and examining whether genetic variation in the SERT gene influences these participants' response to treatment.

Participants will be randomly assigned to receive either escitalopram or placebo for 12 weeks (there is also a 12 week open label extension in which all participants will receive escitalopram). Participants will have weekly/biweekly study visits; during these visits, participants will complete self-report questionnaires on functional ability and anxiety symptoms. Blood collection and cognitive testing through various tasks will also occur.

Arms: arm 1: Escitalopram arm 2: Placebo
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.

Protocol documents:
Clinical trial NCT00108953
Conditions: Carcinoma, Hepatocellular
Keywords: Cancer Liver Cancer Hepatocellular carcinoma HCC
Sponsor: Bayer
Start date: 2005-04-01; Completion date: 2008-04-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

Detailed description:
In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations.

The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.

The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).

Arms: arm 1: "Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks) arm 2: "Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin intervention 2: Doxorubicin/Placebo
Intervention descriptions: intervention 1: Multi kinase inhibitor plus Chemotherapy intervention 2: Chemotherapy plus Placebo

Protocol documents:
Clinical trial NCT00110136
Conditions: Breast Cancer Hot Flashes
Keywords: recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer breast cancer in situ ductal breast carcinoma in situ hot flashes
Sponsor: Wake Forest University Health Sciences
Start date: 2006-03-16; Completion date: 2008-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer.

PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot flashes in women with non-metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of Hypericum perforatum (St. John's wort) in alleviating hot flashes, in terms of hot flash frequency, score, and duration and disruption of daily activities caused by hot flashes, in postmenopausal women with non-metastatic breast cancer.
* Determine hot flash changes over 4 weeks in patients treated with this drug.

Secondary

* Determine the toxicity of this drug in these patients.
* Determine the effect of Hypericum perforatum (St. John's wort) on serum tamoxifen levels in women receiving tamoxifen therapy.
* Determine the effect of Hypericum perforatum (St. John's wort) on general health-related quality of life and mood at 2 and 4 weeks relative to baseline, and during the 2 week post-treatment phase in these patients.
* To evaluate changes in average weekly hot flush scores and duration over course of study.

OUTLINE: This is a multicenter study.

Patients receive oral Hypericum perforatum (St. John's wort) three times daily for 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete a daily diary of the frequency, severity, and duration of their hot flashes, and complete quality of life and mood assessments every 2 weeks during study treatment and continuing weekly for 2 weeks after completion of study treatment.

Patients receiving tamoxifen will have blood tests to measure serum tamoxifen levels at baseline, 2, 4, and 6 weeks.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Arms: arm 1: Patient given one 300mg St. John's Wort tablet three times per day
Interventions: intervention 1: St. John's Wort
Intervention descriptions: intervention 1: St. John's Wort 300mg tablet three times per day

Protocol documents:
Clinical trial NCT00110617
Conditions: Sickle Cell Disease Iron Overload Hemolytic Anemia
Keywords: Sickle Cell Disease Iron Overload from Repeated Blood Transfusions Iron Overload Blood Transfusions
Sponsor: Novartis Pharmaceuticals
Start date: 2005-05-01; Completion date: 2008-04-01
Enrollment: 212 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions.

Detailed description:

Arms: arm 1: Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. arm 2: Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
Interventions: intervention 1: Deferasirox (ICL670) intervention 2: Deferoxamine (DFO)
Intervention descriptions: intervention 1: Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day. intervention 2: Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.

Protocol documents:
Clinical trial NCT00124449
Conditions: Arthritis, Rheumatoid
Sponsor: Bristol-Myers Squibb
Start date: 2005-02-01; Completion date: 2008-04-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Abatacept intervention 2: placebo
Intervention descriptions: intervention 1: solution, intravenous injection, monthly, 169 days

weight based:

\<60 kg = 500 mg

60 to 100 kg = 750 mg

\>100 kg = 1 g intervention 2: solution, intravenous injection, 0 mg, monthly, 169 days

Protocol documents:
Clinical trial NCT00125138
Conditions: Parkinson's Disease Psychotic Disorders
Sponsor: Lundbeck LLC
Start date: 2005-07-01; Completion date: 2008-04-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will have the option of continuing in an open-label extension study.

Detailed description:
Parkinson's Disease is a progressive neurodegenerative disorder characterized by bradykinesia, rigidity, tremor and abnormal posture and gait. Many patients can have mild to moderate symptoms, while others with advanced disease have symptoms which interfere with activities of daily living to a severe degree. Although effective in addressing motor dysfunction, long-term use of anti-Parkinsonian agents has been implicated as a component in the development of psychiatric side effects including psychosis. Treatment of psychosis with typical antipsychotics is not recommended in this patient population, since even low potency typical antipsychotics can cause marked exacerbations of parkinsonism in Parkinson's disease patients. The use of atypical antipsychotics (e.g., clozapine, risperidone and quetiapine) has shown some efficacy in the treatment of psychosis in PD patients. Melperone is classified atypical antipsychotic. European experience with melperone spans more than 30 years, and it encompasses an established antipsychotic efficacy profile in the treatment of confusion, anxiety, unrest (particularly in the elderly) and schizophrenia as well as a favorable safety and tolerability profile. Eligible subjects with Parkinson's disease psychosis will participate in a 1-2 week Screening/Washout Period, a 5 week Titration Phase (one of three doses of melperone or placebo), a 1 week Maintenance Phase and a Taper/Follow-up Period up to 2 weeks. Following the Day 43 assessment, subjects may be given the option of receiving melperone in an open-label extension study.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Melperone HCl intervention 2: Melperone HCl intervention 3: Melperone HCl intervention 4: Placebo
Intervention descriptions: intervention 1: 20 mg/day. Strength of melperone syrup is 5 mg/mL intervention 2: 40 mg/day. Strength of melperone syrup is 5 mg/mL intervention 3: 60 mg/day. Strength of melperone syrup is 5 mg/mL intervention 4: Syrup formulation

Protocol documents:
Clinical trial NCT00129285
Conditions: Cocaine-Related Disorders
Keywords: cocaine
Sponsor: University of Pennsylvania
Start date: 2004-07-01; Completion date: 2008-04-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals.

Detailed description:
Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions. Due to its stimulant-like properties, modafinil is also likely to relieve severe cocaine withdrawal symptoms. In turn, this may lead to better clinical outcomes. The purpose of this study is to determine whether modafinil improves abstinence during early recovery from cocaine dependence.

This 6-month, double-blind, placebo-controlled trial will enroll 210 participants with current DSM-IV diagnoses of cocaine dependence. Treatment will occur for 8 weeks. Participants will be randomly assigned to receive a single morning dose of low-dose modafinil (200 mg/day), high-dose modafinil (400 mg/day), or matching placebo tablets. In addition, each week participants will receive manual-guided cognitive behavioral therapy at the Treatment Research Center. At the end of the 8-week treatment period, modafinil or placebo will be abruptly discontinued. One week following, an end of medication evaluation will occur. In addition to this, two follow-up evaluations will take place 3 and 5 months after initial randomization. Efforts will be made to continue evaluation of subjects who decide to discontinue the modafinil treatment. Urine benzoylecgonine levels will be used to measure cocaine abstinence. Craving, withdrawal, retention, and adverse events will also be evaluated.

Arms: arm 1: Low Dose Modafinil 200 mg daily arm 2: High dose modafinil 400 mg daily arm 3: Placebo
Interventions: intervention 1: Low Dose Modafinil intervention 2: High Dose Modafinil intervention 3: Placebo
Intervention descriptions: intervention 1: modafinil 200 mg/day intervention 2: modafinil 400 mg/day intervention 3: placebo 400 mg/day

Protocol documents:
Clinical trial NCT00142168
Conditions: Waldenstrom's Macroglobulinemia
Keywords: CC-5103 (lenalidomide) rituximab Waldenstrom's macroglobulinemia
Sponsor: Dana-Farber Cancer Institute
Start date: 2004-09-01; Completion date: 2008-04-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last.

Detailed description:
* The study drug CC-5103 (lenalidomide) will be administered orally once daily for 21 days followed by 7 days of no CC-5103 (lenalidomide) (this will be one 28 day treatment cycle). This cycle will repeat itself every 28 days as long as the patient is tolerating the medication and there is no disease progression.
* Starting on the second week, patients will begin treatment with rituximab intravenously once a week for 4 weeks (week 2-5). Prior to each treatment, patients will receive medications to prevent or reduce the side effects of rituximab (benadryl, tylenol and possible decadron). During the infusion, the patients' blood pressure and pulse will be monitored frequently and the rate of infusion may decrease depending upon the side effects. Blood work will also be performed each week.
* On week 12 the disease status will be evaluated. A physical exam, blood test, CT scan and bone marrow biopsy may be repeated if necessary to fully evaluate the disease. If the disease has gone away completely, some tests may be repeated again to confirm this.
* If the disease has gotten worse after 12 weeks, then the patient will be removed from the study.
* If the disease is stable or getting better, the patient will continue with therapy. During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be taken daily for 21 days followed by 7 days of rest. This 28 day cycle may be repeated until the patient has completed 48 weeks (12 months) of treatment as long as the side effects are acceptable and the disease does not progress.
* All patients will undergo an off-study evaluation that includes a physical exam, blood work, CT scans and bone marrow biopsy. If the patient completes 78 weeks of therapy and the disease does not get worse, they will be evaluated every 12 weeks to determine the status of their disease for up to 2 years.

Arms: arm 1: Intended therapy consisted of 48 weeks of CC-5103 (lenalidomide)(25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
Interventions: intervention 1: CC-5103 (lenalidomide) intervention 2: Rituximab
Intervention descriptions: intervention 1: Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide) intervention 2: Begins on week 2 of treatment and is given intravenously once a week for 4 weeks

Protocol documents:
Clinical trial NCT00143312
Conditions: Prophylaxis Of Invasive Fungal Infections
Keywords: Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole
Sponsor: Pfizer
Start date: 2005-02-01; Completion date: 2008-04-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: voriconazole
Intervention descriptions: intervention 1: Voriconazole is given to patients at least 48 hours after chemotherapy

Protocol documents:
Clinical trial NCT00147212
Conditions: Prostate Cancer
Keywords: Advanced Prostate Cancer Prostate Cancer Trabectedin ET 743 Yondelis
Sponsor: Massachusetts General Hospital
Start date: 2002-06-01; Completion date: 2008-04-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.

Detailed description:
* Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. This four week period constitutes one cycle.
* Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours.
* On day 1 of each cycle a history, physical exam and blood tests will be performed and trabectedin will be administered.
* On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered.
* Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects.
* Scans (CT, MRI or bone) or x-rays may be done while the patient is on the trial at the discretion of the physician.

Arms: arm 1: ET-743
Interventions: intervention 1: ET 743
Intervention descriptions: intervention 1: ET-743 administered IV by 24-hr infusion every 3 weeks

Protocol documents:
Clinical trial NCT00171210
Conditions: Transfusional Iron Overload in β-thalassemia
Keywords: β-thalassemia iron overload deferasirox
Sponsor: Novartis Pharmaceuticals
Start date: 2004-10-01; Completion date: 2008-04-01
Enrollment: 506 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.

The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

Detailed description:

Arms: arm 1: All participants received Deferasirox (ICL670) orally once a day. Dosage based on body weight.
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: Tablets taken orally once a day.

Protocol documents:
Clinical trial NCT00177970
Conditions: Clostridium Difficile-associated Diarrhea (CDAD)
Sponsor: University of Pittsburgh
Start date: 2003-10-01; Completion date: 2008-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this trial, eligible patients will be randomly assigned to receive a single dose of 400 mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their usual medications for CDAD. We expect to enroll approximately 40 patients over a period of two years from UPMC Shadyside Hospital, McKeesport Hospital, and St. Margaret's Hospital who are unresponsive to standard antimicrobial therapy for CDAD.

During the course of this study we expect that IVIG group compared with placebo group will have fewer number of stools per day (\< 3 per day). Secondary endpoints will include normal WBC count, normal body temperature, 75% reduction in abdominal pain / tenderness, and decrease in length of hospital stay.

Subjects will sign a written informed consent prior to any study procedures. Patients will be monitored closely during the infusion of the study medication and will continue to be monitored on a daily basis up to the time of discharge. Data collection will include vital signs, CBC, stool C. difficile cytotoxin assay, and stool counts before and after therapy.

Detailed description:
See "Brief Summary" for details

Arms: arm 1: None arm 2: None
Interventions: intervention 1: intravenous immunoglobulin G (IVIG) intervention 2: Placebo
Intervention descriptions: intervention 1: IVIG to be given IV to patients with C-Diff . intervention 2: Placebo to be given IV to patients with C-Diff

Protocol documents: