ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00679354
Conditions: Childhood High-grade Cerebellar Astrocytoma Childhood High-grade Cerebral Astrocytoma Recurrent Childhood Anaplastic Astrocytoma Recurrent Childhood Anaplastic Oligoastrocytoma Recurrent Childhood Anaplastic Oligodendroglioma Recurrent Childhood Brain Tumor Recurrent Childhood Cerebellar Astrocytoma Recurrent Childhood Cerebral Astrocytoma Recurrent Childhood Glioblastoma Recurrent Childhood Visual Pathway and Hypothalamic Glioma
Sponsor: National Cancer Institute (NCI)
Start date: 2008-06-01; Completion date: 2011-07-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective response rate to cilengitide in younger patients with recurrent or progressive high-grade glioma that is refractory to standard therapy.

SECONDARY OBJECTIVES:

I. To estimate the distribution of time to progression, time to treatment failure, and time to death in these patients.

II. To estimate the rate of toxicity, especially symptomatic intratumoral hemorrhage, in these patients.

III. To evaluate the pharmacokinetics of cilengitide in plasma using a limited sampling strategy.

IV. To evaluate the pharmacogenetic polymorphisms in drug transporters (eg, breast cancer resistance protein \[BCRP\], P-glycoprotein \[P-gp\]) and relate to cilengitide disposition.

OUTLINE:

Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then periodically for 3 years.

Arms: arm 1: Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cilengitide intervention 2: laboratory biomarker analysis intervention 3: pharmacological study
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00705367
Conditions: Lupus Nephritis
Sponsor: Bristol-Myers Squibb
Start date: 2008-08-01; Completion date: 2011-07-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Open-label long-term extension phase
Interventions: intervention 1: Placebo intervention 2: Abatacept intervention 3: Abatacept
Intervention descriptions: intervention 1: Infusion, Intravenous, single dose, Day 1 intervention 2: Infusion, Intravenous, 30mg/kg, single dose, Day 1 intervention 3: Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study

Protocol documents:
Clinical trial NCT00710021
Conditions: Systemic Lupus Erythematosus SLE Lupus
Keywords: Systemic lupus erythematosus SLE Vitamin D3 Vitamin D deficiency IFN alpha expression
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2008-11-01; Completion date: 2011-07-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the impact of vitamin D3 on the expression of alpha interferon (IFN alpha) expression in systemic lupus erythematosus (SLE) patients with vitamin D deficiency.

Detailed description:
Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies with subsequent immune complex deposition and tissue inflammation. The role of interferon (IFN) alpha in the development of SLE has been repeatedly documented. Vitamin D deficiency is common among lupus patients. Vitamin D is recognized as a regulator of immune response. This study will explore the impact of vitamin D3 supplementation on IFN alpha expression in SLE patients.

The study will last approximately 12 weeks and consist of three treatment groups: 1.) Participants will receive vitamin D3 2000 IU daily 2.) Participants will receive vitamin D3 4000 IU daily 3.) Participants will receive a vitamin D3 placebo daily. There will be four study visits for each participant. Visits will occur at screening, study entry, and Weeks 6 and 12. Physical examination, vital signs, and blood and urine tests will occur at all visits. For females of childbearing potential, a pregnancy test will be performed at screening and Week 6.

Arms: arm 1: Participants in this arm take a vitamin D3 dose of 2000 international units (IU) daily by mouth for a duration of 12 weeks. arm 2: Participants in this arm take a vitamin D3 dose of 4000 international units (IU) daily by mouth for a duration of 12 weeks. arm 3: Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks.
Interventions: intervention 1: Vitamin D3 intervention 2: Vitamin D3 placebo
Intervention descriptions: intervention 1: 8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight intervention 2: 86% microcrystalline cellulose, 14% fumed silica by weight

Protocol documents:
Clinical trial NCT00717314
Conditions: Liver Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2008-05-01; Completion date: 2011-07-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or 2) CellCept 2.0g/day po bid + \>=75% reduction of CNI from baseline. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Participants received mycophenolate mofetil (MMF), 1.5 to 2.0 grams (g) daily, orally (PO), twice per day (BID) from baseline (BL) to Week 52. Participants also received a 50 percent (%) reduced dose of calcineurin inhibitor (CNI) from BL to Week 52. arm 2: Participants received MMF, 1.5 to 2.0 g daily, PO, BID from BL to Week 52. Participants also received a 75% reduced dose of CNI from BL to Week 52.
Interventions: intervention 1: Mycophenolate mofetil intervention 2: CNI (50%) intervention 3: CNI (≥75%)
Intervention descriptions: intervention 1: 1.5 to 2.0 g daily PO BID intervention 2: 50% reduction from BL intervention 3: ≥75% reduction from BL

Protocol documents:
Clinical trial NCT00727194
Conditions: Myasthenia Gravis
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2008-10-01; Completion date: 2011-07-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.

Detailed description:

Arms: arm 1: eculizumab arm 2: Placebo
Interventions: intervention 1: eculizumab intervention 2: Placebo
Intervention descriptions: intervention 1: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses intervention 2: Placebo IV weekly for 4 doses then every two weeks for 7 doses

Protocol documents:
Clinical trial NCT00727597
Conditions: Human Immunodeficiency Virus Infections
Sponsor: Georgetown University
Start date: 2008-07-01; Completion date: 2011-07-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.

Detailed description:
The objective of this study is to gain tolerability and efficacy data for Norvir-boosted Lexiva versus Sustiva, both used in combination with Epzicom, as components of a first-line, once daily regimen for the treatment of HIV-1 infection in a patient population that is underrepresented in US clinical research.

Arms: arm 1: Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg). arm 2: QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Interventions: intervention 1: Efavirenz 600mg intervention 2: Boosted Lexiva
Intervention descriptions: intervention 1: QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)

The intervention may be switched for the following reasons:

* To resolve a Grade 3 or 4 Adverse Event
* The subject experienced a virologic failure (as defined in section 3.6.2)
* The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
* The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide) intervention 2: Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)

The intervention may be switched for the following reasons:

* To resolve a Grade 3 or 4 Adverse Event
* The subject experienced a virologic failure (as defined in section 3.6.2)
* The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
* The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)

Protocol documents:
Clinical trial NCT00728923
Conditions: Obsessive Compulsive Disorder
Keywords: OCD
Sponsor: New York State Psychiatric Institute
Start date: 2008-08-01; Completion date: 2011-07-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study we are recruiting patients to receive the drug NPL-2003, which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are taking in a 12-week open label study.

Detailed description:

Arms: arm 1: Minocycline (NPL-2003)
Interventions: intervention 1: NPL-2003
Intervention descriptions: intervention 1: Minocycline (NPL-2003) daily for 12 weeks

Protocol documents:
Clinical trial NCT00734656
Conditions: Alcohol Related Disorders Alcoholism Alcohol Abuse
Keywords: steroid 5Alpha Reductase dutasteride neuroactive steroid
Sponsor: UConn Health
Start date: 2007-03-01; Completion date: 2011-07-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will explore the hypothesis that effects of alcohol are in part mediated by increased production of neuroactive steroids, which interact with GABAA-receptors. We propose to study non-dependent drinkers using a 4-session within-subjects design in which alcohol / placebo is paired with dutasteride / placebo pretreatment. Dutasteride is a 5-alpha steroid reductase (5AR) inhibitor that limits the production of dihydrotestosterone and the 5a-reduced neuroactive steroids allopregnanolone, pregnanolone and 3a,5a-androstanediol.

Detailed description:
Alcohol has multiple pharmacological effects, though which of these effects relate to the risk of alcohol dependence is not clear. Animal studies indicate that the neuroactive steroid allopregnanolone is an alcohol-modulated endogenous agonist at GABAA receptors and that genetic variation in steroid 5a-reductase type I gene which generates neuroactive steroids, may moderate alcohol effects. To better define the role of neuroactive steroids we will conduct a laboratory study of non-alcohol dependent drinkers using a 4-session design in which alcohol/placebo beverage is paired with dutasteride/placebo pretreatment. Dutasteride, an inhibitor of both type I and type II 5a-reductase enzymes, blocks the production of 5a-reduced neuroactive steroids. This study will extend our preliminary findings with finasteride by including a) a placebo control for alcohol, b) a more specific inhibitor of both 5a-reductase isoenzymes, c) a larger group of subjects (including both light and heavy drinkers).

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: dutasteride + ethanol intervention 2: placebo medication + ethanol intervention 3: dutasteride + placebo alcohol intervention 4: placebo medication + placebo alcohol
Intervention descriptions: intervention 1: 4 mg dutasteride administered 2-4 days prior to ingestion of 0.8 mg/kg ethanol divided between three drinks consumed over 36 minutes intervention 2: placebo medication administered 2-4 days prior to ingestion of 0.8 gr/kg ethanol divided between three drinks consumed over 36 minutes intervention 3: 4 mg dutasteride administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes intervention 4: placebo medication administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes

Protocol documents:
Clinical trial NCT00749580
Conditions: Virus Diseases HIV
Keywords: Safety
Sponsor: University of South Florida
Start date: 2008-11-01; Completion date: 2011-07-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether raltegravir 400 mg b.i.d. in a boosted PI regimen is as efficacious and safe as the NRTI backbone in a boosted PI regimen.

Detailed description:

Arms: arm 1: Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen Subjects in this study are HIV-Infected Patients who are on a stable boosted PI regimen; in this group are assigned to switched from their NRTIs as a Backbone to Raltegravir arm 2: Group 2 Continue the same regimen without change
Interventions: intervention 1: Switch NRTIs as a Backbone to Raltegravir
Intervention descriptions: intervention 1: This is a multicenter, pilot randomized, controlled study to evaluate the safety and efficacy of raltegravir in patients switched from a stable boosted PI-based regimen with a NRTI backbone to raltegravir instead of their current NRTIs. A stable boosted PI-based regimen is defined as having a documented HIV RNA \<75 copies/mL for ≥ 3 months prior to study entry, while receiving a boosted PI-based with NRTI backbone. Additionally, patients must not have had HIV RNA ≥ 75 copies/mL during the three months prior to study entry. Approximately 25 patients will be enrolled in the raltegravir treatment arm (Group 1) and approximately 25 patients in the continuation of the current NRTI backbone regimen treatment arm (Group 2). Patients will be randomly assigned 1:1 to a treatment group.

Protocol documents:
Clinical trial NCT00750880
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2008-09-01; Completion date: 2011-07-01
Enrollment: 1681 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8mg/kg iv (60 minute infusion)

Protocol documents:
Clinical trial NCT00751114
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Start date: 2008-11-01; Completion date: 2011-07-01
Enrollment: 515 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.

Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:

* HbA1c level
* Fasting Plasma Glucose (FPG)
* 7-point plasma glucose (PG) profiles
* Percentage of patients with HbA1c \<7% and \<6.5%

Safety objectives consisted of:

* Hypoglycemia occurrence
* Body weight
* Overall safety

Detailed description:

Arms: arm 1: Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L). arm 2: Dose of 100 mg once a day administered with or without food.
Interventions: intervention 1: Insulin Glargine intervention 2: Sitagliptin intervention 3: Metformin
Intervention descriptions: intervention 1: Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL). intervention 2: Oral administration. 100 mg film-coated tablets. intervention 3: Patients continued with metformin as usual oral anti-diabetic treatment.

Protocol documents:
Clinical trial NCT00760461
Conditions: Gastroparesis
Sponsor: Yale University
Start date: 2008-10-01; Completion date: 2011-07-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Domperidone
Intervention descriptions: intervention 1: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily

Protocol documents:
Clinical trial NCT00762320
Conditions: HIV Infections
Keywords: HIV Kaletra treatment Experienced
Sponsor: Phoenix Children's Hospital
Start date: 2008-10-01; Completion date: 2011-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective medications that are approved and available for young children who are HIV+. The liquid form is reported to have a very nasty taste and presents difficulties for the children who must take the medication twice a day and for their parents who must enforce the medication regimen. The children are often well into their teens before they weigh enough to be able to take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now available. However, it is not known if the liquid and tablet act the same in children. The purpose of this study is to switch children from the baseline treatment with the liquid to the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will compare children pre-switch and post-switch in terms of how well their HIV is controlled . Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children currently well managed with a medications including liquid Kaletra will be invited to switch from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the parent and/or child will complete the satisfaction survey. In addition, at the switch and 1 month post switch, a day will be spent in clinic with 5 blood draws to see how much of the drug is in the blood stream at different times after the medicine is taken.

Detailed description:

Arms: arm 1: Patients will serve as their own controls as they are switched from the baseline treatment with liquid Kaletra to the study intervention treatment with Low Dose Tablet Kaletra (100mg/25mg)
Interventions: intervention 1: Low dose Kaletra tablets
Intervention descriptions: intervention 1: Lopinavir/Ritonavir tablets 100mg/25mg

Protocol documents:
Clinical trial NCT00771472
Conditions: Lymphoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-08-01; Completion date: 2011-07-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: vorinostat
Intervention descriptions: intervention 1: Parts I \& II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.

Protocol documents:
Clinical trial NCT00772538
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2008-10-01; Completion date: 2011-07-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma.

The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.

Detailed description:

Arms: arm 1: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution arm 2: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Interventions: intervention 1: tiotropium 5mcg/day intervention 2: placebo
Intervention descriptions: intervention 1: Intervention = randomisation: Patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo intervention 2: Matching placebo

Protocol documents: