ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00179517
Conditions: Seizure Disorder Hypogonadism Erectile Dysfunction
Keywords: Seizure Epilepsy Testosterone Hormone Sexual Dysfunction Hypogonadism Men
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2001-06-01; Completion date: 2008-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if treatment using a medication (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any active medication, when combined with testosterone replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole, the medication that is currently under study, does not, at this time, have FDA approval for use for this indication.

Detailed description:
This is a three-month study where baseline information is collected at the first visit and then each patient is started on treatment with testosterone supplementation and either anastrozole or placebo. Lab tests, seizure frequency, sexual function and mood will be monitored on a monthly basis.

Arms: arm 1: Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes an oral tablet of anastrozole 1 mg daily for the duration of the study. This group is referred to as the depotestosterone plus anastrozole (T-A) group. arm 2: Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo oral tablet daily for the duration of the study. This group is referred to as the depotestosterone plus placebo (T-P) group.
Interventions: intervention 1: Anastrozole 1mg intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00179673
Conditions: Non-Hodgkins Lymphoma
Keywords: NHL CC5013 Non-Hodgkins Lymphoma revlimid cc-5013 celgene
Sponsor: Celgene
Start date: 2005-06-01; Completion date: 2008-04-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28-day cycle. Treatment will continue for up to 52 weeks or until disease progression; subjects who achieve a Complete Response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Subjects will be followed for progression free survival following discontinuation from the treatment phase

Detailed description:

Arms: arm 1: Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00181844
Conditions: Bipolar Disorder Mania
Keywords: bipolar disorder lamotrigine children mania
Sponsor: Massachusetts General Hospital
Start date: 2005-01-01; Completion date: 2008-04-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.

Detailed description:
Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania,\& mixed episodes) in patients treated for acute mood episodes with standard therapy. Recent studies have shown that Lamotrigine maintenance treatment was more robust in bipolar depression.

The study includes 1) use of a 12-week design to document the response rate 2) assessment of the impact of Lamotrigine on functional capacities and cognition, 3) careful assessment of safety and tolerability.

Arms: arm 1: None
Interventions: intervention 1: lamotrigine
Intervention descriptions: intervention 1: Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children \<12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.

Protocol documents:
Clinical trial NCT00187720
Conditions: Other Conditions That May Be A Focus of Clinical Attention
Keywords: Healthy Control
Sponsor: University of California, San Francisco
Start date: 2002-05-01; Completion date: 2008-04-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent, metformin.

Detailed description:
The drug, which is used in the treatment of Type II diabetes, has a narrow therapeutic range. Its net renal clearance by secretion (i.e., renal clearance minus filtration clearance) ranges from approximately 100 ml/min to 800ml/min in normal, healthy subjects. Although many factors may contribute to inter-individual variation in renal secretory clearance, initial estimates of heritability (greater than 0.6) suggest that genetic factors play an important role in the renal secretion of metformin. Available evidence supports the idea that hOCT2 is the primary transporter involved in the first-step of renal secretion of metformin, i.e., uptake from the blood to the tubule cell across the basolateral membrane. In particular, (a) hOCT2 is the primary organic cation transporter on the basolateral membrane of the human kidney; and (b) metformin interacts with and is translocated by hOCT2 in heterologous expression systems.

In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with ethnic-specific allele frequencies ≥1% \[6\] that have altered function in studies in heterologous expression systems. In addition, we identified a common haplotype of hOCT2 and one haplotype that contain the non-synonymous cSNP, A270S. We will determine whether variability in the renal secretory clearance of the model organic cation, metformin, in healthy individuals is associated with genetic variation in hOCT2. In particular, we will determine whether the renal clearance of metformin differs in individuals who are homozygous for the common haplotype of OCT2 (OCT2\*1) and those who are heterozygous for the less common haplotype OCT2\*3D, which we have identified in a comprehensive screen of ethnically identified DNA samples. We will also determine whether individuals who are heterozygous for the less common OCT2 variants, M165I, R400C and K432Q, have reduced renal clearances of metformin.

Arms: arm 1: Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin. arm 2: Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin.
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: Subjects will be given a single oral dose of 850 mg of metformin

Protocol documents:
Clinical trial NCT00206726
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Sponsor: Genzyme, a Sanofi Company
Start date: 2005-05-01; Completion date: 2008-04-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy.

Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.

Detailed description:
As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Arms: arm 1: Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days.
Interventions: intervention 1: Alemtuzumab plus Fludarabine
Intervention descriptions: intervention 1: Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days

Protocol documents:
Clinical trial NCT00213980
Conditions: Breast Cancer
Keywords: bone mineral density postmenopausal women
Sponsor: University of Wisconsin, Madison
Start date: 2000-01-01; Completion date: 2008-04-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.

Detailed description:
This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer. An approved bisphosphonate, alendronate, is of benefit in patients with osteoporosis, however, this agent has a roughly 30% incidence of gastrointestinal symptoms and up to 50% of patients may take the drug improperly, compromising absorption and potentially efficacy. Zoledronate is a heterocyclic imidazole third generation bisphosphonate, which is administered intravenously (IV) and has little toxicity. Zoledronate is more potent than alendronate, and because of its route of administration it does not have the problems of poor oral bioavailability and non-compliance.

Arms: arm 1: Observation only for 12 months arm 2: Zoledronate
Interventions: intervention 1: Zoledronate
Intervention descriptions: intervention 1: 4 mg IV over 15 minutes administered once every 12 weeks times 4

Protocol documents:
Clinical trial NCT00235755
Conditions: Seizures
Keywords: Partial Seizures Complex Partial Seizures Epilepsy Potassium Channels Anticonvulsant
Sponsor: GlaxoSmithKline
Start date: 2005-12-01; Completion date: 2008-04-01
Enrollment: 539 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

Detailed description:
This Phase 3 study is being conducted in Europe, Israel, Australia, and South Africa to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Retigabine intervention 2: Retigabine intervention 3: Placebo
Intervention descriptions: intervention 1: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase. intervention 2: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase. intervention 3: Oral tablet.

Protocol documents:
Clinical trial NCT00244140
Conditions: Computed Tomography Diagnostic Imaging
Keywords: Ultravist 370 CECT CT Scan
Sponsor: Bayer
Start date: 2005-10-01; Completion date: 2008-04-01
Enrollment: 435 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician.

Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body

Detailed description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Arms: arm 1: Iopromide (Ultravist 370 mg I/mL) administered intravenously arm 2: Iopromide (Ultravist 300 mg I/mL) administered intravenously
Interventions: intervention 1: Iopromide 370 mg I/mL intervention 2: Iopromide 300 mg I/mL
Intervention descriptions: intervention 1: Iopromide (Ultravist 370 mg I/mL) administered intravenously intervention 2: Iopromide (Ultravist 300 mg I/mL) administered intravenously

Protocol documents:
Clinical trial NCT00247273
Conditions: Postmenopausal Osteoporosis
Keywords: randomized controlled trial, osteoporosis, risedronate
Sponsor: Warner Chilcott
Start date: 2005-10-01; Completion date: 2008-04-01
Enrollment: 1294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Detailed description:
The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Arms: arm 1: 5 mg risedronate, once daily for 2 years arm 2: 150 mg risedronate taken once a month for 2 years
Interventions: intervention 1: risedronate intervention 2: risedronate
Intervention descriptions: intervention 1: tablet, 5 mg risedronate, once a day for 2 years intervention 2: oral, 150 mg risedronate, once a month for 2 years

Protocol documents:
Clinical trial NCT00252694
Conditions: Type 2 Diabetes
Keywords: Diabetes mellitus type 2
Sponsor: AstraZeneca
Start date: 2001-08-01; Completion date: 2008-04-01
Enrollment: 4717 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.

Detailed description:

Arms: arm 1: candesartan cilexetil 32 mg once daily arm 2: control
Interventions: intervention 1: candesartan
Intervention descriptions: intervention 1: 32 mg oral tablet

Protocol documents:
Clinical trial NCT00291655
Conditions: Epilepsy
Keywords: NEWLY DIAGNOSED EPILEPSY LEVETIRACETAM KEPPRA N01175 (NCT00175903)
Sponsor: UCB Pharma
Start date: 2006-06-01; Completion date: 2008-04-01
Enrollment: 130 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.

To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: 500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study

Protocol documents:
Clinical trial NCT00302081
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic Genotype 2 and Genotype 3
Sponsor: Merck Sharp & Dohme LLC
Start date: 2003-08-01; Completion date: 2008-04-01
Enrollment: 696 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\] .

Detailed description:
This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\].

Arms: arm 1: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks arm 2: PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks arm 3: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
Interventions: intervention 1: peginterferon alfa-2b (SCH 54031) intervention 2: peginterferon alfa-2b (SCH 54031) intervention 3: peginterferon alfa-2b (SCH 54031) intervention 4: ribavirin (SCH 18908) intervention 5: ribavirin (SCH 18908)
Intervention descriptions: intervention 1: 1.5 mcg/kg QW SC for 24 weeks intervention 2: 1.0 mcg/kg QW SC for 24 weeks intervention 3: 1.5 mcg/kg QW SC for 16 weeks intervention 4: 800-1200 mg daily for 24 weeks intervention 5: 800-1200 mg daily for 16 weeks

Protocol documents:
Clinical trial NCT00306475
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: schizophrenia, cognition, mood stabilizer
Sponsor: Northwestern University
Start date: 2006-03-01; Completion date: 2008-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.

Detailed description:
Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. It has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and caretaker burden. Preclinical data from our laboratory provided the rationale for a clinical trial to test whether divalproex sodium ER can improve cognitive impairment in patients.

The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Divalproex Sodium Extended-Release Tablets intervention 2: placebo
Intervention descriptions: intervention 1: divalproex sodium extended-release (ER) 1000 mg intervention 2: placebo identical in appearance to active comparator

Protocol documents:
Clinical trial NCT00311155
Conditions: Essential Hypertension
Keywords: Olmesartan medoxomil Hypertension
Sponsor: Sankyo Pharma Gmbh
Start date: 2006-03-01; Completion date: 2008-04-01
Enrollment: 694 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

Detailed description:

Arms: arm 1: Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary:

Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary:

Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks
Interventions: intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Intervention descriptions: intervention 1: Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.

Protocol documents: