ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00466687
Conditions: Melanoma
Keywords: stage IV melanoma recurrent melanoma
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2004-09-01; Completion date: 2008-09-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IV melanoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the overall response rate, response duration, and frequency of progression-free survival at 6 months in patients with stage IV melanoma treated with erlotinib hydrochloride and bevacizumab.
* Determine objective responses in patients treated with this regimen.

Secondary

* Determine the overall safety and tolerability of this regimen in these patients.
* Evaluate tissue blocks for EGFR by monoclonal antibody H11 (DAKO) or fluorescence in situ hybridization(FISH)7p12-specific probe-overexpression or amplification in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tissue collection to analyze EGFR by monoclonal antibody H11 (DAKO) or fluorescence in situ hybridization (FISH) 7p12-specific probe-overexpression or amplification. Biological markers AKT, MAPK, p27, p21, CD13, CD34, and factor VIII are also measured.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Tarceva and Avastin:

* Tarceva: 150mg PO, days 1-28
* Avastin: 10mg/kg, IV infusion, days 1,15 Regimen will be repeated every 28 days = 1 course
Interventions: intervention 1: bevacizumab intervention 2: erlotinib hydrochloride intervention 3: fluorescence in situ hybridization intervention 4: gene expression analysis intervention 5: immunologic technique intervention 6: laboratory biomarker analysis intervention 7: biopsy
Intervention descriptions: intervention 1: 10mg/kg, slow IV infusion, Days 1 and 14 intervention 2: 150mg PO qd intervention 3: Targeting multiple genetic aberrations in isolated tumor cells. intervention 4: gene expression analysis intervention 5: immunologic technique intervention 6: laboratory biomarker analysis intervention 7: biopsy

Protocol documents:
Clinical trial NCT00467389
Conditions: Cocaine Abuse and Dependence
Keywords: Acetylcholine Acetylcholinesterase Butyrylcholinesterase Cholinesterase Inhibitor
Sponsor: US Department of Veterans Affairs
Start date: 2007-02-01; Completion date: 2008-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.

Detailed description:
This is a randomized, double-blind, double-dummy, placebo controlled, inpatient, single-center, parallel group evaluation of the potential for oral donepezil to attenuate cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive baseline treatment with intravenous cocaine (30Mg). Forty-two subjects that tolerate baseline cocaine infusions will then receive two subsequent intravenous doses of cocaine during double-blind treatment with oral placebo or 5 mg daily of donepezil. Each dose of cocaine will be preceded or followed by administration of intravenous placebo (saline) in a random order.

Arms: arm 1: Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil arm 2: Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.
Interventions: intervention 1: Donepezil, 5 mg daily intervention 2: Oral Placebo
Intervention descriptions: intervention 1: This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease. intervention 2: Inactive Comparator with Similar Appearance to Active Medication

Protocol documents:
Clinical trial NCT00468481
Conditions: Neural Tube Defects Contraception Oral Contraceptives (OC)
Keywords: Healthy women requesting contraception Folic Acid
Sponsor: Bayer
Start date: 2007-04-01; Completion date: 2008-09-01
Enrollment: 385 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the study drug is safe and effective

Detailed description:
Acronym is used in result section: suspected/diagnosed (susp/diag)

Arms: arm 1: 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks arm 2: 1 tablet 0.020 mg EE/3.0 mg DRSP \[YAZ\] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
Interventions: intervention 1: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate intervention 2: Drospirenone/Ethinylestradiol (Yaz)
Intervention descriptions: intervention 1: 0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF) intervention 2: 0.020 mg ethinylestradiol with 3.0 mg drospirenone

Protocol documents:
Clinical trial NCT00470600
Conditions: Pain
Sponsor: Cumberland Pharmaceuticals
Start date: 2007-05-01; Completion date: 2008-09-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.

Detailed description:

Arms: arm 1: 250 milliliters normal saline as a placebo comparator was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period. arm 2: 800 mg of intravenous ibuprofen diluted in 250 milliliters normal saline was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period.
Interventions: intervention 1: Caldolor intervention 2: Normal Saline
Intervention descriptions: intervention 1: 800 milligrams intravenous intervention 2: Placebo comparator

Protocol documents:
Clinical trial NCT00479167
Conditions: Follicular Lymphoma
Keywords: Non-Hodgkin's Lymphoma Follicular Non-Hodgkin's Lymphoma Lymphoma
Sponsor: Rush University Medical Center
Start date: 2007-05-01; Completion date: 2008-09-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine what dose of bortezomib in combination with tositumomab I-131 is tolerable whether bortezomib and Tositumomab I-131 are effective in the treatment of relapsed or refractory non-hodgkin's lymphoma (NHL). Both agents are effective in treating relapsed and refractory NHL. Administer of the agents together may sensitize the cells to the radiation from Tositumomab I-131.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bortezomib and Tositumomab I-131
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00494013
Conditions: Diabetes Mellitus Type 2
Keywords: diabetes type 2
Sponsor: Eli Lilly and Company
Start date: 2007-08-01; Completion date: 2008-09-01
Enrollment: 442 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Detailed description:

Arms: arm 1: Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. arm 2: Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
Interventions: intervention 1: Insulin Lispro Protamine Suspension intervention 2: Detemir
Intervention descriptions: intervention 1: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. intervention 2: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

Protocol documents:
Clinical trial NCT00495677
Conditions: HIV
Keywords: Treatment Experienced Treatment Naive
Sponsor: Pfizer
Start date: 2007-06-01; Completion date: 2008-09-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: PF-00232798 intervention 2: PF-00232798 intervention 3: PF-00232798 intervention 4: PF-00232798 intervention 5: PF-00232798 intervention 6: PF-00232798
Intervention descriptions: intervention 1: Solution, 20 mg. once daily, 10 days intervention 2: Solution, 150 mg. once daily, 10 days intervention 3: Solution, 5 mg. once daily, 10 days intervention 4: Solution, 40 mg. once daily, 10 days intervention 5: Solution, 300 mg. once daily, 10 days intervention 6: Solution, 400 mg. once daily, 10 days

Protocol documents:
Clinical trial NCT00498797
Conditions: Prostate Cancer Metastatic Hormone Refractory
Keywords: prostate cancer zactima vandetanib metastatic
Sponsor: Sanofi
Start date: 2005-12-01; Completion date: 2008-09-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with Zactima (vandetanib) in combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer who have not previously received chemotherapy.

Detailed description:

Interventions: intervention 1: Zactima (vandetanib) intervention 2: Docetaxel intervention 3: Prednisolone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00500539
Conditions: Asthma
Keywords: Asthma omalizumab safety allergic asthma adolescents
Sponsor: Novartis
Start date: 2007-07-01; Completion date: 2008-09-01
Enrollment: 155 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Detailed description:

Interventions: intervention 1: omalizumab
Intervention descriptions: intervention 1: The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.

Protocol documents:
Clinical trial NCT00501228
Conditions: Graft-Versus-Host Disease
Keywords: Graft-Versus-Host Disease Stem Cell Transplantation Tissue Repair Organ-Specific Tissue Damage Filgrastim RhG-CSF
Sponsor: M.D. Anderson Cancer Center
Start date: 2003-02-01; Completion date: 2008-09-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

1\. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation.

Secondary Objective:

1\. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.

Detailed description:
It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity, skin cells, and/or cells of various organs. RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available.

Before treatment starts, participants will have at least one (and up to three) biopsy(ies) of damaged tissue performed to find out about the severity of tissue damage. A biopsy is taken with a large needle. Women able to have children must have a negative blood pregnancy test.

Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week. This will be repeated every other week for a total of 4 weeks. Blood tests (about 2 teaspoons each) will be performed 3 times while at M. D. Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range. Participants will have at least one (and up to three) biopsy(ies) again performed about 8 weeks after the start of rhG-CSF treatment. An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it, and not for research purposes only.

Participants will be taken off study if severe side effects occur. The study will end after the last biopsy or biopsies are taken, about 3 months after the start of rhG-CSF treatment.

This is an investigational study. RhG-CSF is FDA approved and commercially available, though its use in this study is investigational. A maximum of 5 patients will be treated on this protocol. All will be enrolled at M. D. Anderson.

Arms: arm 1: None
Interventions: intervention 1: Filgrastim
Intervention descriptions: intervention 1: 5 mg/kg ID Once Daily x 1 Week

Protocol documents:
Clinical trial NCT00504595
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: Novartis
Start date: 2007-05-01; Completion date: 2008-09-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was intended to assess the safety, efficacy, and response to treatment using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile in adult patients with established rheumatoid arthritis

Detailed description:

Arms: arm 1: Healthy Volunteers: Single administration of 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1.

Rheumatoid Arthritis (RA) Patients: Dose of 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43. arm 2: Healthy Volunteers: Single administration of 600 mg of Placebo Intravenous (IV) on Day 1.

Rheumatoid Arthritis (RA) Patients: Dose of 600 mg of Placebo Intravenous (IV) on Day 1, Day 15, and Day 43.
Interventions: intervention 1: ACZ885 (investigational) intervention 2: Placebo
Intervention descriptions: intervention 1: The ACZ885 was supplied in 6 mL colorless glass vials each containing nominally 150 mg ACZ885 (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered. intervention 2: Matching placebo of ACZ885 was supplied in the form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.

Protocol documents:
Clinical trial NCT00517192
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2007-09-01; Completion date: 2008-09-01
Enrollment: 40 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

Detailed description:

Interventions: intervention 1: Tipranavir intervention 2: Darunavir intervention 3: Ritonavir
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00518622
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-01; Completion date: 2008-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C

Detailed description:

Arms: arm 1: 25 mg b.i.d. MK7009 arm 2: 75 mg b.i.d. MK7009 arm 3: 250 mg b.i.d. MK7009 arm 4: 500 mg b.i.d. MK7009 arm 5: 700 mg b.i.d. MK7009 arm 6: 125 mg q.d. MK7009 arm 7: 600 mg q.d. MK7009 arm 8: Placebo
Interventions: intervention 1: Comparator: MK7009 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8. intervention 2: MK7009 Placebo

Protocol documents:
Clinical trial NCT00527319
Conditions: Cachexia
Keywords: NSCLC anorexia cachexia grip strength lean body mass
Sponsor: Vicus Therapeutics
Start date: 2007-01-01; Completion date: 2008-09-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized.

To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.

Detailed description:
The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen

This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.

Arms: arm 1: Supportive care only arm 2: VT-122 (dose of etodolac: 400 mg/day) + supportive care arm 3: VT-122 (dose of etodolac: 800 mg/day) + supportive care
Interventions: intervention 1: VT-122 low dose intervention 2: VT-122 high dose
Intervention descriptions: intervention 1: VT-122 low dose, dose escalated intervention 2: VT-122 high dose, dose escalated

Protocol documents:
Clinical trial NCT00529789
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2007-08-01; Completion date: 2008-09-01
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily orally is tolerated and safe, in children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) with Major Depressive Disorder.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: duloxetine
Intervention descriptions: intervention 1: 20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is \>40 kg, initial dose is 30 mg, then titrated up.

Protocol documents:
Clinical trial NCT00531752
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Pfizer
Start date: 2007-12-01; Completion date: 2008-09-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg), and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants will be required to washout of prior ADHD medication before entering the study. Participants will be required to come to the site for 10 visits over approximately a 10-week period.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: PF-03654746 intervention 2: Placebo capsules intervention 3: PF-03654746
Intervention descriptions: intervention 1: Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21 intervention 2: Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period. intervention 3: Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 1 mg (2 x 0.5 mg capsules) of PF-03654746 given daily for three weeks

Protocol documents:
Clinical trial NCT00534599
Conditions: Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States
Keywords: Generalized anxiety disorders anxiety adjunct treatment in anxiety anxiety disorder partial or non-responder in anxiety
Sponsor: AstraZeneca
Start date: 2007-08-01; Completion date: 2008-09-01
Enrollment: 409 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

Detailed description:

Arms: arm 1: Adjunctive Placebo Seroquel XR to anxiety treatment arm 2: Adjunctive Seroquel XR to anxiety treatment
Interventions: intervention 1: Placebo intervention 2: quetiapine fumarate XR
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents: