ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00945477
Conditions: Prostate Cancer
Sponsor: Illinois CancerCare, P.C.
Start date: 2009-07-01; Completion date: 2012-10-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A growing body of literature supports the role of angiogenesis in the development and spread of a variety of human cancers including prostate cancer.

* Vascular endothelial growth factor (VEGF) expression is low in normal prostate tissue, but markedly increased in tumor tissues, and has a positive association with tumor stage and grade
* Plasma VEGF levels are significantly elevated in patients with hormone refractory prostate cancer (HRPC) compared to those patients with localized disease and have been associated with disease progression in other cancer patient population.
* The Cancer and Leukemic Group-B demonstrated that VEGF levels correlate with survival.

Pazopanib is a potent multi-target receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors.

Detailed description:
VEGF expression is low in all normal prostate tissue, but markedly increased in tumor tissue, and has a positive association with MVD (micro vessel density) tumor stage, grade, and disease-specific survival in patients with prostate cancer. VEGF is known to be under the influence of HIF-1α, which is also up-regulated in the majority of prostate cancer tissue. It has been shown that complete androgen blockade down-regulates VEGF expression via the HIF-1α pathway with concomitant up-regulation of thrombospondin and induction of endothelial cell apoptosis. The VEGF pathway appears to be the dominant vascular formation pathway in prostate cancer with bFGF having a lesser role.

Pazopanib , a hydrochloride salt, is a small molecule inhibitor of several tyrosine kinases, ie: VEGF 1, 2, 3, c-KIT and platelet-derived growth factor receptors. The broad blockade of the VEGF receptors should interfere with the VEGF/VEGF-receptor pathway, and have an impact on cell growth.

According to the NCCN guidelines , first line therapy for metastatic prostate cancer is considered total androgen blockade, either utilizing orchiectomy and/or LH/RH agonists plus Casodex.

Second line therapy would depend on the patient's response to first line therapy, urgency of a response, and the location of metastatic disease.

Pazopanib has been explored in several settings. It has recently been looked at with Bicalutamide in hormone refractory prostate cancer. The second study was with earlier disease, i.e. D-0 relapse androgen-sensitive patients. The University of Chicago has a study looking at the sub-population of prostate cancer patients that have a "chemical relapse" in which patients are given one shot of Lupron, and if the PSA is adequately suppressed, the patients are randomized between pazopanib and placebo.

Arms: arm 1: Pazopanib
Interventions: intervention 1: Pazopanib (GW786034)
Intervention descriptions: intervention 1: Pazopanib 800 mg daily x 12 weeks

Protocol documents:
Clinical trial NCT00975715
Conditions: Partial Onset Seizures
Keywords: Seizures oxcarbazepine child
Sponsor: Novartis Pharmaceuticals
Start date: 2009-09-01; Completion date: 2012-10-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.

Detailed description:

Arms: arm 1: Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. arm 2: Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
Interventions: intervention 1: TRI476 intervention 2: Placebo to TRI476 intervention 3: Benzodiazepines
Intervention descriptions: intervention 1: TRI476 oral suspension doses, based on body weight twice daily intervention 2: Placebo oral suspension, taken twice daily intervention 3: Benzodiazepines could be used as needed as rescue medication during the duration of the study.

Protocol documents:
Clinical trial NCT00976508
Conditions: Colorectal Neoplasms Lung Neoplasms Breast Neoplasms Prostatic Neoplasms Sarcoma
Keywords: advanced solid tumors cancer refractory cancer figitumumab pegvisomant
Sponsor: Pfizer
Start date: 2009-11-01; Completion date: 2012-10-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.

Detailed description:
This study was closed to enrollment on 18 April 2011 due to inability to recruit patients on a timely basis as well as business reasons. Study closure was not related to any safety concerns.

Arms: arm 1: None
Interventions: intervention 1: figitumumab intervention 2: pegvisomant
Intervention descriptions: intervention 1: IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year intervention 2: growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year

Protocol documents:
Clinical trial NCT01001832
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2009-12-01; Completion date: 2012-10-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of abatacept after subcutaneous and intravenous administration in Japanese participants with active rheumatoid arthritis and inadequate response to methotrexate.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Intravenous (IV) abatacept intervention 2: Subcutaneous (SC) abatacept
Intervention descriptions: intervention 1: IV vial, 125-mg infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. intervention 2: Solution in prefilled syringes, SC, 125 mg, once weekly, for 169 days and then for 52 weeks

Protocol documents:
Clinical trial NCT01034176
Conditions: BK Viremia
Keywords: BK viremia kidney transplantation BK viremia in kidney transplant recipients
Sponsor: Brigham and Women's Hospital
Start date: 2009-02-01; Completion date: 2012-10-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients with persistent viremia (BK virus found in blood) will impair progress to BK virus induced kidney damage by significantly decreasing or eliminating BK virus in the blood.

Detailed description:

Arms: arm 1: Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days arm 2: placebo identical to levofloxacin drug daily for 30 days
Interventions: intervention 1: levofloxacin intervention 2: placebo
Intervention descriptions: intervention 1: 500 mg tablet, daily, 30 days intervention 2: no dose, tablet, daily, 30 days

Protocol documents:
Clinical trial NCT01049984
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease UPDRS Clinical Global Evaluation Illness Severity score Clinical Global Evaluation Improvement B-SIT SCOPA - Sleep Daytime Sleepiness PDQ -39 SCOPA - Cognition Levodopa rasagiline Dopamine Agonist Therapy monoamine oxidase type B inhibitor
Sponsor: Teva Neuroscience, Inc.
Start date: 2009-12-01; Completion date: 2012-10-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.

Detailed description:

Arms: arm 1: Participants took a 1 mg rasagiline tablet orally each day for 18 weeks. arm 2: Participants took a matching placebo tablet once daily for 18 weeks.
Interventions: intervention 1: Rasagiline intervention 2: Placebo
Intervention descriptions: intervention 1: 1mg tablet daily for 18 weeks intervention 2: one tablet daily for 18 weeks

Protocol documents:
Clinical trial NCT01057589
Conditions: Head and Neck Neoplasms
Keywords: Pharynx Larynx Cervical esophagus Nose Thyroid Gland Parathyroid Gland
Sponsor: Eli Lilly and Company
Start date: 2010-02-01; Completion date: 2012-10-01
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

Detailed description:
A 12 patient safety lead will evaluate side effects in patients receiving at least 2 cycles of the combination pemetrexed, cisplatin and cetuximab.

Arms: arm 1: Participants will receive pemetrexed,cisplatin and cetuximab for up to 6 cycles (21 days per cycle) followed by optional maintenance of pemetrexed and cetuximab until disease progression. Optional maintenance therapy is permitted after at least 4 cycles of triplet combination therapy have been given. Cetuximab will be administered as an initial dose of 400 milligram per meter squared (mg/m\^2) intravenous (IV) infusion and as a 250 mg/m\^2 IV weekly dose thereafter.

As Standard of care dietary supplements included: 350 to 1000 micrograms (µg) oral Folic Acid 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed and 1000 µg vitamin B12 intramuscular injection (IM) during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.
Interventions: intervention 1: Pemetrexed intervention 2: Cetuximab intervention 3: Cisplatin intervention 4: Folic Acid intervention 5: Vitamin B12
Intervention descriptions: intervention 1: Triplet Combination Therapy: 500 mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles

Maintenance Therapy: 500mg/m\^2 administered intravenously on Day 1 of 21 day cycle until disease progression or unacceptable toxicity intervention 2: Triplet Combination Therapy: 400 mg/m\^2 administered intravenously on Day 1 of 21 day cycle for 1 cycle; 250 mg/m\^2 administered IV infusion on Day 1 of 21 day cycle and then weekly for up to 6 cycles.

Maintenance Therapy: 250 mg/m\^2 administered intravenously on Day 1 of 21 day cycle and then weekly until disease progression or unacceptable toxicity intervention 3: Triplet Combination Therapy: 75mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles. intervention 4: Standard of care dietary supplements: 350 to 1000 µg orally 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed. intervention 5: Standard of care dietary supplements: 1000 µg IM during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Protocol documents:
Clinical trial NCT01061606
Conditions: Recurrent Uterine Sarcoma Uterine Carcinosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-01-01; Completion date: 2012-10-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well temsirolimus works in treating patients with recurrent or persistent cancer of the uterus. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Assess the efficacy of Temsirolimus in women with recurrent or persistent (after primary therapy) Carcinosarcoma (MMMT) of the uterus.

II. Assess the safety and tolerability of Temsirolimus in this patient population.

III. Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival (PFS), 6 month PFS rate, and duration of response.

SECONDARY OBJECTIVES:

I. Overall survival II.Duration of Response III. Time to progression IV. Time to treatment failure

OUTLINE: This is a multicenter study.

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically for up to 3 years.

Arms: arm 1: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: temsirolimus
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT01083758
Conditions: Scalp Psoriasis
Sponsor: LEO Pharma
Start date: 2010-04-01; Completion date: 2012-10-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis. LEO 80185 topical suspension has marketing approval in many countries under the brand names Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)
Intervention descriptions: intervention 1: Topical suspension applied once daily for up to 8 weeks

Protocol documents:
Clinical trial NCT01118962
Conditions: Epilepsy
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures Absence Seizures Myoclonic Seizures Idiopathic Generalized Epilepsy (IGE)
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2010-08-01; Completion date: 2012-10-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.

Detailed description:

Arms: arm 1: Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).

Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.

Protocol documents:
Clinical trial NCT01120223
Conditions: Scalp Psoriasis
Sponsor: LEO Pharma
Start date: 2010-05-01; Completion date: 2012-10-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Intervention descriptions: intervention 1: Once daily application

Protocol documents:
Clinical trial NCT01128270
Conditions: Healthy
Keywords: Dichloroacetate Chloral Hydrate Metabolism
Sponsor: University of Florida
Start date: 2010-04-01; Completion date: 2012-10-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This is a research study to look at how Dichloroacetate (DCA), and investigational drug and chloral hydrate are broken down in the body. The purpose of the study is to better understand how humans metabolize these two common chemicals that are widely present in the environment. The study focuses on how the drug chloral hydrate is broken down and how it effects DCA

Detailed description:
The subject's general health is assessed by a history and physical exam and routine blood work. I normal the individual undergoes five nights of receiving 1.5ug/kg of chloral hydrate. On day 6 the individual receives 2.5 micrograms/kg of Dichloroacetate (DCA) and kinetics are drawn. After 30 days the subject comes back and receives 1.5ug/kg of chloral hydrate for five nights and has kinetics drawn on night one and five. On days 6-9 the subject returns for a blood draw. After 30 days the same process as above is done except the subject receives 1gram of chloral hydrate for five nights and 25mg/kg of Dichloroacetate one day then 30 days later the subject receives 1gram of chloral hydrate for five nights and has kinetics done on night one and five and blood samples drawn on days 6-9

Arms: arm 1: Subjects consume Chloral Hydrate 1.5ug/kg by mouth for 5 nights. On the 6th day they consume DCA 2.5ug/kg by mouth and have blood samples drawn. (Period 1) arm 2: Drug Study Subjects are admitted to the clinical research unit and receive 1.5 ug/kg (environmental dose) of Chloral Hydrate for 5 nights. Pharmacokinetics are done on days 1 and day 5. (Period 2) arm 3: Drug Study Subjects are admitted to the clinical research center and receive a clinical dose of Chloral Hydrate for 5 nights (25mg/kg). On day 6 they are given a clinical dose (25mg/kg)of Dichloroacetate. (Period 3) arm 4: Subjects are given 25 mg/kg of Chloral Hydrate for five nights. Pharmacokinetics are done on days 1 and 5. (Period 4)
Interventions: intervention 1: Dichloroacetate environmental dose intervention 2: Chloral Hydrate environmental dose intervention 3: Dichloroacetate therapeutic dose intervention 4: Chloral Hydrate therapeutic dose
Intervention descriptions: intervention 1: On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics. intervention 2: Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5. intervention 3: Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5. intervention 4: Subject is given 25 mg/kg of Chloral Hydrate for five nights.

Protocol documents:
Clinical trial NCT01134055
Conditions: Macular Degeneration
Keywords: ranibizumab wet AMD MD7110852 age related macular degeneration age-related macular degeneration macular degeneration pazopanib
Sponsor: GlaxoSmithKline
Start date: 2010-06-01; Completion date: 2012-10-01
Enrollment: 510 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.

Detailed description:
MD7110852 is a Phase 2b dose-ranging study designed to demonstrate the 1 year efficacy and safety of pazopanib eye drops for the treatment of neovascular age related macular degeneration (AMD) in subjects whose disease is currently managed with anti-VEGF (vascular endothelial growth factor) injection therapy. Eye drop regimens are double-masked with placebo eye drops and will have access to open-label ranibizumab intravitreal (IVT) injection if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.

Arms: arm 1: 5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection arm 2: 5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection arm 3: 10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection arm 4: 10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection arm 5: 10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection arm 6: Placebo eye drops QID with allowance for as-needed ranibizumab injection arm 7: Ranibizumab intravitreal injection every 4 weeks
Interventions: intervention 1: pazopanib eye drops intervention 2: placebo intervention 3: ranibizumab intravitreal injection
Intervention descriptions: intervention 1: A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors. intervention 2: placebo eye drops intervention 3: Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A

Protocol documents:
Clinical trial NCT01143207
Conditions: Contraception
Keywords: AE adverse event DCF data collection forms DMC Data Monitoring Committee FDA U.S.) Food and Drug Administration GCP Good Clinical Practice guidelines ICH International Conference of Harmonisation IND Investigational New Drug Application IRB Institutional Review Board IU International units mg milligram(s) SAE serious adverse event µg microgram ULN upper limit of the normal range
Sponsor: FHI 360
Start date: 2010-05-01; Completion date: 2012-10-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception

Detailed description:
A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm

Arms: arm 1: Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Interventions: intervention 1: Medroxyprogesterone acetate
Intervention descriptions: intervention 1: Injectable hormonal contraceptive

Protocol documents: