ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00392392
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-10-01; Completion date: 2011-12-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.

Detailed description:
All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention. If surgical intervention is deemed not to be in the best interest of the patient, patient will go off study at the time of evaluation for surgery. Upon completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on Tamoxifen 20 mg/qd or an aromatase inhibitor.

Induction preoperative therapy:

* Bevacizumab
* Trastuzumab
* ABI-007
* Carboplatin

Postoperative Adjuvant Therapy:

* Bevacizumab
* Trastuzumab

Arms: arm 1: Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
Interventions: intervention 1: nab-paclitaxel intervention 2: Bevacizumab intervention 3: Trastuzumab
Intervention descriptions: intervention 1: ABI-007 intervention 2: Bevacizumab intervention 3: Trastuzumab

Protocol documents:
Clinical trial NCT00395850
Conditions: Cocaine Dependence
Keywords: cocaine dependence disulfiram clinical trial methadone maintenance pharmacogenetics dopamine beta-hydroxylase
Sponsor: University of Arkansas
Start date: 2007-04-01; Completion date: 2011-12-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines the influence of dopamine beta-hydroxylase enzyme activity on the clinical efficacy of the novel pharmacotherapy, disulfiram, for treating cocaine dependence in cocaine-dependent patients, some of whom are opioid dependent and maintained on an FDA-approved opioid agonist. Cocaine dependence as well as co-morbid cocaine and opioid-dependence is associated with more public health issues and poorer treatment prognosis when admitted to methadone maintenance. Yet no effective pharmacotherapies have been developed to treat cocaine dependence to date. One novel pharmacotherapy, disulfiram, has shown some promise as a treatment for this disorder in several clinical trials at a dose of 250 mg/day or more (e.g., Carroll et al., 1998, 2004). This 14-week, randomized, double blind clinical trial will provide treatment for up to160 cocaine-dependent individuals, aged 18-65 years. Participants who are opioid dependent will be stabilized on methadone maintenance during the first 2 weeks and baseline cocaine use will be assessed; participants will be stratified by DBH genotype and randomly assigned to receive disulfiram at either 0, 250, 375 or 500 mg/day. During induction onto methadone for opioid dependent individuals, participants are administered increasing doses of methadone on a daily basis until maintenance doses are attained. At the beginning of week 3, participants receive methadone, if relevant, plus disulfiram or placebo disulfiram according to their randomized assignments, and are maintained on study medication(s) through week 14. At the end of the study, participants will undergo detoxification from the opioid agonist, if relevant, and active/placebo medication over a 4- to 6-week period. All participants receive weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who will receive ongoing supervision. Participants undergo a delay discounting session during week 1. The primary outcomes will be retention, reduction in opioid and cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalyses, and disulfiram side-effects profile. Secondary outcomes will include reductions in other illicit drug and alcohol use, and improvements in psychosocial functioning. The prognostic relevance of genotype at the DBH locus, DβH activity, etc., on response to disulfiram will be examined.

Detailed description:

Arms: arm 1: microcrystalline cellulose arm 2: disulfiram at 250 mg/day arm 3: Disulfiram at 375 mg/day arm 4: Disulfiram at 500 mg/day
Interventions: intervention 1: Disulfiram
Intervention descriptions: intervention 1: Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks

Protocol documents:
Clinical trial NCT00400569
Conditions: Liposarcoma Leiomyosarcoma Fibrosarcoma Malignant Fibrous Histiocytoma
Keywords: Sunitinib malate SUTENT SU011248 Soft tissue sarcoma Gastrointestinal stromal tumors (GIST) MFH Tyrosine kinase inhibitor Imatinib mesylate Phase II
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2006-11-01; Completion date: 2011-12-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity.

All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.

Detailed description:
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial Principal Investigator (PI) compromises the ability of the patient to receive treatment or the patient desires to stop treatment.

All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.

An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every scheduled visit.

Arms: arm 1: Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Interventions: intervention 1: Sunitinib Malate (SU011248)
Intervention descriptions: intervention 1: For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.

Protocol documents:
Clinical trial NCT00404495
Conditions: Glioma Medulloblastoma
Sponsor: Pfizer
Start date: 2007-04-01; Completion date: 2011-12-01
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Irinotecan intervention 2: Temozolomide
Intervention descriptions: intervention 1: Irinotecan 10 mg/m\^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles intervention 2: Temozolomide 100-125 mg/m\^2 daily on days 1-5 in repeated 3 week cycles

Protocol documents:
Clinical trial NCT00409838
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, with inadequate response to methotrexate
Sponsor: Bristol-Myers Squibb
Start date: 2007-04-01; Completion date: 2011-12-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate

Detailed description:

Arms: arm 1: None arm 2: (standard of care) arm 3: Open-label extension phase
Interventions: intervention 1: Abatacept intervention 2: Methotrexate intervention 3: Placebo intervention 4: Abatacept intervention 5: Methotrexate
Intervention descriptions: intervention 1: Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months intervention 2: Tablets, Oral, ≥ 15 mg, weekly, 6 months intervention 3: IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months intervention 4: Solution, intravenous, 10 mg/kg, every 28 days intervention 5: Tablets, oral, 15 mg weekly to be adjusted according to patient condition

Protocol documents:
Clinical trial NCT00443534
Conditions: Neoplasms
Sponsor: Pfizer
Start date: 2006-05-01; Completion date: 2011-12-01
Enrollment: 123 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SU011248
Intervention descriptions: intervention 1: Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol

Protocol documents:
Clinical trial NCT00451321
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 diabetes mellitus diabetes mellitus type 1 type 1 diabetes diabetes mellitus diabetes
Sponsor: GlaxoSmithKline
Start date: 2006-07-31; Completion date: 2011-12-01
Enrollment: 88 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Otelixizumab
Intervention descriptions: intervention 1: Infusion

Protocol documents:
Clinical trial NCT00451698
Conditions: Congenital Heart Defect
Keywords: Erythropoietin Congenital heart surgery
Sponsor: Medical College of Wisconsin
Start date: 2007-10-01; Completion date: 2011-12-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury.

This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects.

Detailed description:
Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. A medicine already used in humans, erythropoietin, may protect the heart and brain of children born with heart defects during their surgical repair. In a rabbit model, erythropoietin did protect the hearts. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury.

For this randomized control trial, 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects, will be divided into four groups. Two groups will be children whose usual blood oxygen level is low because of their heart defect; the other two will be children with normal blood oxygen levels. Each child will be randomized to receive either erythropoietin or placebo 15 minutes prior to stopping the heart during their surgery.

Erythropoietin's protective function will be measured after surgery by: (1) amount of medication required to support heart function, (2) how well the heart pumps blood as seen by echocardiogram, (3) levels of chemicals produced by the body when heart or brain tissue injury occurs, (4) urine output and oxygen levels (5) time on ventilator support (6) ICU stay and (7) hospital stay. Heart tissue will be collected during surgery to determine how erythropoietin protects heart cells.

Statistical tests including ANOVA will test for similarities and differences among the groups on the measures of protection from injury.

Note - the study design was edited after the FDA released a warning about the use of erythropoietin. Only acyanotic patients were recruited therefore only 2 study groups are included.

Arms: arm 1: acyanotic placebo arm 2: acyanotic erythropoietin
Interventions: intervention 1: acyanotic erythropoietin intervention 2: acyanotic placebo
Intervention descriptions: intervention 1: Single dose IV push intervention 2: Single dose IV push

Protocol documents:
Clinical trial NCT00465452
Conditions: Parkinson Disease
Sponsor: University of Toledo
Start date: 2007-01-01; Completion date: 2011-12-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Side effects that we will monitor in particular include somnolence, peripheral edema, cognitive decline with and without hallucinations. PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms: somnolence, cognitive impairment with or without hallucinations, or peripheral edema will be offered the opportunity to participate in this study.

Detailed description:
The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Side effects that we will monitor in particular include somnolence, peripheral edema, cognitive decline with and without hallucinations. PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms: somnolence, cognitive impairment with or without hallucinations, or peripheral edema will be offered the opportunity to participate in this study.

Fifteen subjects who are currently receiving pramipexole therapy (monotherapy or adjunctive therapy) who are experiencing one or more of the following symptoms: somnolence, cognitive decline with/without hallucinations, and peripheral edema will be asked if they are willing to participate at the time of their clinic visit at the PDMDP.

The crossover from pramipexole to ropinirole CR will be performed over a 2 week interval. During the first week, the initial drug dose will substitute ½ of the pramipexole with ½ of the target dose of ropinirole CR. If subjects are tolerating the drug change, then 100% of the target dose of ropinirole CR (and no pramipexole) will be started in the second week.

Arms: arm 1: Continuous Release Dopamine Agonists
Interventions: intervention 1: Continuous Release Dopamine Agonists
Intervention descriptions: intervention 1: Continuous Release Dopamine Agonists

Protocol documents:
Clinical trial NCT00465894
Conditions: Overactive Bladder
Keywords: overactive bladder urge leakage nightime urination incontinence urinary frequency
Sponsor: University of Alabama at Birmingham
Start date: 2007-04-01; Completion date: 2011-12-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.

Detailed description:
Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews.

In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections.

Comparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms

Arms: arm 1: An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence. arm 2: For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.
Interventions: intervention 1: Extended Release Tolterodine LA intervention 2: Intra Vaginal Estradiol Cream
Intervention descriptions: intervention 1: Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks intervention 2: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00467753
Conditions: Autism
Keywords: Irritability Functional Ability Aggression Mood Instability
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2006-04-01; Completion date: 2011-12-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.

Detailed description:
The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism. Subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has any psychiatric or medical illnesses that would interfere with their ability to participate in this study. These evaluations may take up to an hour to complete. In addition, subjects will be asked to participate in a psychiatric interview designed to determine the child's diagnosis and current problem areas. The subject's parent will also be asked to fill out psychiatric questionnaires. The interview and questionnaires may take up to 4 hours to complete.

Arms: arm 1: Oxcarbazepine is the active drug to be given to subjects in the experimental arm arm 2: Patients are given either active or inactive intervention.
Interventions: intervention 1: Oxcarbazepine intervention 2: Placebo/sugar pill
Intervention descriptions: intervention 1: Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the morning for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a Clinical Global Improvement Scale (CGI) of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose. intervention 2: Dosage similar to active drug

Protocol documents:
Clinical trial NCT00508027
Conditions: Sickle Cell Disease
Keywords: sickle cell disease simvastatin statin drugs nitric oxide donors vascular injury
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2007-06-01; Completion date: 2011-12-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Recent clinical and experimental data indicate that statins have effects beyond cholesterol lowering that may be beneficial in sickle cell disease by protecting the vascular endothelium. Statins have been shown to attenuate endothelial dysfunction through their anti-inflammatory, anti-oxidant and anti-thrombotic properties. This phase I/II dose-escalating trial is designed to assess the safety and potential clinical efficacy of oral simvastatin (Zocor)in adolescents and adults with sickle cell disease (SCD).

Detailed description:
Although statins have been used extensively for their cholesterol-lowering effects, recent clinical and experimental data indicate that statins regulate yet other processes, many of which play a major role in sickle cell disease (SCD). Independent of their cholesterol-lowering effects, statins have been shown to prevent damage to blood vessels in several ways, through upregulation of endothelial nitric oxide (NO)and decreased inflammation. Numerous studies documenting the protective effects of statins, together with data showing the therapeutic role of NO in SCD, provide the basis for investigating the potential clinical benefit of simvastatin in SCD.

Data supporting the safety and tolerability of simvastatin in patients with SCD are now needed. For this phase I/II dose-escalation study of oral simvastatin in SCD, we propose the following specific aims:

1. To obtain preliminary efficacy data on the effects of oral simvastatin on plasma biomarkers of endothelial injury in patients with SCD, and
2. To assess the safety and tolerability of oral simvastatin in patients with SCD.

Arms: arm 1: There are no arms in this study. Simvastatin will be given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).
Interventions: intervention 1: Simvastatin
Intervention descriptions: intervention 1: Comparison of 3 dosages of simvastatin given in a dose-escalating fashion. 20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days.

Protocol documents: