ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00314340
Conditions: Chronic Pain
Keywords: Chronic Pain Opioids
Sponsor: University of California, Davis
Start date: 2005-11-01; Completion date: 2008-04-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.

Detailed description:
A placebo-controlled, double-blind, crossover trial will be conducted providing study subjects either hydrocodone/acetaminophen 30mg/975mg, sustained release morphine 45mg or placebo on separate GCRC visits. A long acting comparator (slow-release morphine sulfate 45 mg) will be chosen because of its putative equianalgesic effects to the dose of hydrocodone (30 mg) selected. Subjects will participate in the three sessions at the UC Davis/Mather Medical Center General Clinical Research Center (GCRC) at intervals of 7-10 days. Sessions will be approximately 360 min in duration. Subjects will receive either hydrocodone/acetaminophen or sustained release morphine around-the-clock for 7-10 days prior to the experimental session. At each experimental session, an assessment of abuse liability will be completed before the intake of medications, as well as at 0, 60, 120, 180, 240 minutes after the ingestion of the study medication.

Arms: arm 1: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity

On one of three study dates, subjects received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO). The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect to the dose of hydrocodone-acetaminophen (30/925 mg). arm 2: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity

On the day of the study session, patients received hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg (APAP;Qualitest Pharmaceuticals Inc, Huntsville, AL). arm 3: Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.
Interventions: intervention 1: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity intervention 2: ER Morphine intervention 3: hydrocodone plus acetaminophen intervention 4: placebo
Intervention descriptions: intervention 1: The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety of subjects. intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00317941
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple Sclerosis RRMS
Sponsor: Bayer
Start date: 2006-03-01; Completion date: 2008-04-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.

Detailed description:
Original French title of the study: Etude de phase IV, multicentrique, randomisée, ouverte, comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée d'interféron β-1b (Betaferon®) ou interféron β-1a (Rebif®) pendant la période de trois mois d'initiation de la thérapie chez des patients atteints d'une forme récurrente/rémittente de sclérose en plaques.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Arms: arm 1: Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject arm 2: Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light arm 3: Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
Interventions: intervention 1: Betaferon/Betaseron intervention 2: Rebif intervention 3: Betaferon/Betaseron
Intervention descriptions: intervention 1: 250ug administrated with Betaject intervention 2: 44ug administered with Rebiject II intervention 3: 250ug administrated with Betaject light

Protocol documents:
Clinical trial NCT00322556
Conditions: Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency
Keywords: Immunoglobulin Intravenous Agammaglobulinemia Hypogammaglobulinemia Common variable immunodeficiency Immunoglobulin G Children
Sponsor: CSL Behring
Start date: 2005-11-01; Completion date: 2008-04-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Detailed description:

Arms: arm 1: See Intervention Description
Interventions: intervention 1: Immunoglobulins Intravenous (Human)
Intervention descriptions: intervention 1: Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

Protocol documents:
Clinical trial NCT00331864
Conditions: Age Related Macular Degeneration Choroidal Neovascularization
Keywords: AMD, ranibizumab
Sponsor: Novartis
Start date: 2006-04-01; Completion date: 2008-04-01
Enrollment: 531 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Detailed description:

Arms: arm 1: Ranibizumab-naïve (Non-ANCHOR) patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on re-treatment criteria described in the protocol. For patients who had participated in the ANCHOR study, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met re-treatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00332241
Conditions: Autistic Disorder
Keywords: Serious behavioral problems in children and adolescents with AD Behavioral Problems
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2006-06-01; Completion date: 2008-04-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Detailed description:

Arms: arm 1: Active Abilify arm 2: None
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks intervention 2: Tablets, Oral, once daily, 8 weeks

Protocol documents:
Clinical trial NCT00344370
Conditions: Type II Diabetes Mellitus Dyslipidemia
Keywords: Pitavastatin Type II Diabetes Mellitus Combined Dyslipidemia
Sponsor: Kowa Research Europe
Start date: 2006-08-01; Completion date: 2008-04-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.

Detailed description:

Arms: arm 1: Pitavastatin 4 mg QD arm 2: Atorvastatin 40 mg
Interventions: intervention 1: Pitavastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: Pitavastatin 4 mg QD intervention 2: Atorvastatin 40 mg

Protocol documents:
Clinical trial NCT00346632
Conditions: Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia
Keywords: AML ALL MDS CML Kinase Inhibitor
Sponsor: Kyowa Kirin, Inc.
Start date: 2006-06-01; Completion date: 2008-04-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML, ALL, MDS and CML.

Detailed description:
This is a Phase I open-label dose escalation study of KW-2449 in subjects with acute leukemias, high risk MDS, and CML who are not candidates for approved therapy. Over an 18-month period, the investigative sites collectively will enroll up to a total of 96 subjects. Subjects will be enrolled sequentially into 1 of 7 dose groups to evaluate 2 dosing schedules (Arm A = 14 consecutive days of dosing followed by a 7-28 day rest period as determined by recovery from any acute hematologic and non-hematologic toxicities, or Arm B = 28 consecutive days of dosing followed by a 7-28 day rest period, as determined by recovery from any acute hematologic and non-hematologic toxicities). The safety of a dose level in Arm A (14-day dosing regimen) will be established prior to enrollment of subjects in the same dose level in Arm B (28-day dosing regimen).

In April 2007 the protocol was amended to discontinue Arm B (28 consecutive days of dosing). The protocol will continue as planned for Arm A (14 days of consecutive dosing).

Enrollment will proceed until a maximum tolerated dose (MTD) has been established for each study Arm. Once the MTD has been reached, 12 additional subjects, with 1 or more of the hematologic conditions included in this study, may be enrolled at the MTD as an expanded safety cohort.

Arms: arm 1: Treatment with ascending doses of KW-2449
Interventions: intervention 1: KW-2449
Intervention descriptions: intervention 1: Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing).

Protocol documents:
Clinical trial NCT00353262
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-07-01; Completion date: 2008-04-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Avastin intervention 2: Oxaliplatin intervention 3: capecitabine [Xeloda]
Intervention descriptions: intervention 1: 7.5mg/kg iv (cycle 3 only) intervention 2: 130mg/m2 iv (cycles 1, 2 and 3) intervention 3: 1000mg/m2 po bid (cycles 1, 2 and 3)

Protocol documents:
Clinical trial NCT00359788
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2006-07-01; Completion date: 2008-04-01
Enrollment: 349 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.

Detailed description:

Interventions: intervention 1: tiotropium intervention 2: Combivent (Ipratropium/Albuterol)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00360243
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2006-07-01; Completion date: 2008-04-01
Enrollment: 1385 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Detailed description:

Arms: arm 1: 25 mg twice daily for 24 weeks arm 2: 50 mg taken once daily at bedtime for 24 weeks arm 3: 50 mg twice daily for 24 weeks arm 4: twice daily for 24 weeks
Interventions: intervention 1: flibanserin intervention 2: flibanserin intervention 3: flibanserin intervention 4: placebo
Intervention descriptions: intervention 1: Experimental: flibanserin 25 mg b.i.d intervention 2: Experimental: flibanserin 50mg qhs intervention 3: Experimental: flibanserin 50mg b.i.d. intervention 4: placebo

Protocol documents:
Clinical trial NCT00360308
Conditions: Parkinson's Disease
Sponsor: Eisai Limited
Start date: 2006-11-01; Completion date: 2008-04-01
Enrollment: 723 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomised, double-blind, double dummy, parallel group design. Following the screening period patients will be randomised at the baseline visit, in a 1:1:1 manner, to one of three treatment arms; 4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo. The first 4 weeks of the double blind phase will be used to titrate patients on the E2007 arm from 2 mg up to the maintenance dose of 4 mg. Patients randomised to entacapone or placebo will have dummy up titrations to maintain the blind. Following this titration phase, patients will remain on the maintenance dose for a further 14 weeks.

Patients will have visits at 2, 4, 6, 10, 14 and 18 weeks after baseline. A follow up visit will be performed at Week 22.

A home diary will be completed in which patients rate themselves as either:

1. "OFF"
2. "ON" without dyskinesias
3. "ON" with non-troublesome dyskinesias
4. "ON" with troublesome dyskinesias
5. Asleep

These entries will be completed every 30 minutes during the waking day and will be completed for three consecutive days immediately prior to visits at Baseline, Weeks 6, 10, 18 and 22.

At Baseline (Day 0), week 10 and 18 the Unified Parkinson's Disease Rating Scale (UPDRS - Parts I, II , III and IV) will be performed.

At the end of the treatment period (Week 18), patients will undergo final efficacy and safety assessments and will stop taking the study medication they were receiving. They will be seen 4 weeks later for a follow up visit.

Detailed description:

Arms: arm 1: matching E2007 and matching entacapone arm 2: 2 mg once daily in the evening, Weeks 0→2 (2 weeks) and 4 mg once daily in the evening, Weeks 2→18. arm 3: 200 mg with each dose of Levodopa.
Interventions: intervention 1: Placebo intervention 2: E2007 intervention 3: E2007
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00360412
Conditions: Parkinson's Disease
Sponsor: Eisai Inc.
Start date: 2006-10-01; Completion date: 2008-04-01
Enrollment: 997 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. During the Titration Phase, patients will receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be withdrawn from the study.

Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60).

A home diary will be completed in which patients rate themselves as either:

1. OFF
2. ON without dyskinesia
3. ON with non-troublesome dyskinesias
4. ON with troublesome dyskinesias
5. Asleep

These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20, 32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be performed.

Detailed description:

Arms: arm 1: During the first two weeks of the study, Patients received 1 x 2mg E2007 tablet. At the week 2 visit, patients who tolerated the 2 mg/day dose were up-titrated to receive 4mg/day (2 x 2 mg E2007 tablets). Patients not tolerating the 4 mg dose were allowed to down titrate to 2 mg. Patients who did not tolerate the 2 mg dose were withdrawn from the study. Patients returned at week 4, if their tolerance to the 4 mg/day dose was acceptable they remained on this dose for the maintenance phase of the study. If at any time their tolerance declined, they were to return for an unscheduled visit and the daily dose was reduced to 2 mg. If at any stage, 2 mg day wass not tolerated, the patient was withdrawn from the study.
Interventions: intervention 1: E2007
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00360529
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2006-07-01; Completion date: 2008-04-01
Enrollment: 880 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Detailed description:
This trial was designed as a prospective, multicenter trial containing a 24-week, randomized, double blind, placebo controlled, parallel-group period that assessed the effects of flibanserin (maximum total daily dose: 100 mg q.d.) compared with placebo in premenopausal women with HSDD, determined by Diagnostic and Statistical Manual IV- Text Revision (DSM IV-TR®) criteria. Three hundred patients were to be randomized to each treatment group. This trial examined the safety and efficacy of flibanserin compared to placebo for 24 weeks.

Arms: arm 1: flibanserin 50 mg q.h.s. arm 2: flibanserin 100 mg q.h.s. arm 3: placebo q.h.s.
Interventions: intervention 1: flibanserin
Intervention descriptions: intervention 1: flibanserin placebo versus 50 mg qhs versus 100 mg qhs

Protocol documents:
Clinical trial NCT00361595
Conditions: Osteoporosis
Keywords: osteoporosis zoledronic acid forteo
Sponsor: The Cleveland Clinic
Start date: 2006-08-01; Completion date: 2008-04-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women.

Detailed description:
This will be a single center open label proof of concept study, recruiting subjects previously treated with Forteo for at least 12 months.

A screening period of 3 to 6 weeks will precede the treatment period. At the baseline visit, patients whose eligibility is confirmed will be treated with ZA and followed for 12 months. Safety and efficacy will be assessed at regular intervals (day one, day 10, month 2, month 6, month 9 and month 12). Renal safety will be assessed prior to the i.v. dose of study medication, day 10 after the i.v. dose of study medication and at 12 months. Bone density at the lumbar spine (L1-4) and total hip will be performed at 6 months and at the end of the 12 month treatment period. Biomarker analyses for secondary endpoint will be performed for at day 10, month 2, month 6, month 9 and month 12.

Arms: arm 1: 5 mg zoledronic acid in a single 15 minute IV
Interventions: intervention 1: zoledronic acid
Intervention descriptions: intervention 1: 5 mg zoledronic acid administered in a single 15 minute IV

Protocol documents:
Clinical trial NCT00367679
Conditions: Non-Small Cell Lung Cancer Lung Cancer, Non-Small Cell
Keywords: pazopanib I-ELCAP non-small cell lung cancer antiangiogenesis NSCLC GW786034
Sponsor: GlaxoSmithKline
Start date: 2006-11-01; Completion date: 2008-04-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 2 open-label, multicenter, non-randomized study to evaluate the safety and efficacy of oral pazopanib as neoadjuvant treatment for patients with stage 1A, 1B, IIA or IIB (to T2) resectable Non-Small Cell Lung Cancer (NSCLC).

Detailed description:

Arms: arm 1: 800 mg pazopanib oral daily
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: Pazopanib is an oral, potent, multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit. Subjects were to receive 800 mg oral pazopanib daily for a minimum of 2 weeks to a maximum of 6 weeks.

Protocol documents:
Clinical trial NCT00376623
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2006-07-25; Completion date: 2008-04-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial will be performed to evaluate whether BI 2536 may be effective in the treatment of advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage schedules are compared.

Detailed description:

Arms: arm 1: Day 1 arm 2: Day 1, 2, and 3 arm 3: Day 1, 2, and 3
Interventions: intervention 1: BI 2536
Intervention descriptions: intervention 1: Intravenous Infusion

Protocol documents: