ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00675428
Conditions: Multiple Myeloma
Keywords: Relapsed or refractory Multiple Myeloma
Sponsor: Biogen
Start date: 2008-09-01; Completion date: 2009-12-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical activity.

Detailed description:
Despite no protocol-defined study stopping criteria being met, the sponsor decided to terminate enrollment after the phase 1 portion was complete and to not move into the phase 2 portion of the study. This decision was made due to difficulty enrolling participants and was not due to any safety concerns.

Arms: arm 1: Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months. arm 2: Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
Interventions: intervention 1: BG00002 (natalizumab)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00688701
Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia, GLP-1
Sponsor: Sanofi
Start date: 2008-05-01; Completion date: 2009-12-01
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment.

The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12.

Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed description:
This is a double-blind, randomized, placebo-controlled, 4-arm, unbalanced design, parallel group study with a two-step titration regimen or a one-step titration regimen. The study is double-blind with regard to active and placebo treatments; however neither the study drug volume nor the titration regimens (that is, two-step or one-step) are blinded.

Arms: arm 1: 2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12. arm 2: 1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12. arm 3: 2-step initiation regimen of lixisenatide: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12. arm 4: 1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None

Protocol documents:
Clinical trial NCT00691483
Conditions: Smoking Cessation
Keywords: smoking cessation smoking treatment patient self-selected quit date
Sponsor: Pfizer
Start date: 2008-09-01; Completion date: 2009-12-01
Enrollment: 659 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: varenicline
Intervention descriptions: intervention 1: placebo tablet taken orally twice daily for 12 weeks intervention 2: varenicline tablets, 1 mg taken orally twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00697697
Conditions: Asthma
Keywords: asthmatic children
Sponsor: Allergan
Start date: 2008-04-01; Completion date: 2009-12-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.

Detailed description:

Arms: arm 1: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks arm 2: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Interventions: intervention 1: 0.135mg MAP0010 intervention 2: 0.25mg MAP0010
Intervention descriptions: intervention 1: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks intervention 2: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks

Protocol documents:
Clinical trial NCT00701103
Conditions: Solid Tumor Multiple Myeloma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-01-12; Completion date: 2009-12-01
Enrollment: 80 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.

The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour weekly, every other week, or every three week infusion in participants with advanced cancer will be generally safe and tolerated at a dose which achieves a trough concentration ≥3 μg/mL.

Detailed description:
Trial Duration of Treatment: Participants can be treated for up to two years if their disease has not progressed and they are not having unmanageable side effects.

Arms: arm 1: Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W). arm 2: Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W. arm 3: Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W. arm 4: Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W. arm 5: Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W. arm 6: Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W. arm 7: Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W. arm 8: Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W. arm 9: Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W. arm 10: Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W). arm 11: Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion1 time every 3 weeks (Q3W).
Interventions: intervention 1: Dalotuzumab
Intervention descriptions: intervention 1: IV infusion

Protocol documents:
Clinical trial NCT00701805
Conditions: Secondary Hyperparathyroidism Hemodialysis
Keywords: Secondary hyperparathyroidism Hemodialysis paricalcitol
Sponsor: Abbott
Start date: 2008-07-01; Completion date: 2009-12-01
Enrollment: 107 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).

Detailed description:
The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).

Arms: arm 1: Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. arm 2: Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. arm 3: Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. arm 4: Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Interventions: intervention 1: Paricalcitol
Intervention descriptions: intervention 1: Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

Protocol documents:
Clinical trial NCT00703261
Conditions: Atherosclerotic Vascular Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-08-01; Completion date: 2009-12-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.

Detailed description:

Arms: arm 1: 10 mg atorvastatin + placebo arm 2: 80 mg atorvastatin + placebo
Interventions: intervention 1: atorvastatin intervention 2: placebo
Intervention descriptions: intervention 1: Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day. intervention 2: Participants will be asked to self-administer one tablet of placebo to atorvastatin 10 mg or 80 mg at approximately the same time each day.

Protocol documents:
Clinical trial NCT00703339
Conditions: Idiopathic Pulmonary Fibrosis Pulmonary Hypertension
Keywords: fibrosis, pulmonary hypertension, pulmonary exercise, aerobic
Sponsor: Lung Biotechnology PBC
Start date: 2008-06-01; Completion date: 2009-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to establish single-dose tolerability of inhaled treprostinil sodium in idiopathic pulmonary fibrosis (IPF) patients with pulmonary hypertension, and to explore the acute hemodynamic effects over a range of tolerable doses. The safety and pharmacodynamic information obtained from this study will inform the design and conduct of future studies in inhaled treprostinil sodium in this population.

Detailed description:
This is Phase 2, multi-center, open-label, four-cohort study in subjects with pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). Each cohort of four subjects will receive a single dose of inhaled treprostinil sodium. Cohorts will be enrolled sequentially, starting with the lowest dose of 18 mcg. Each cohort escalate by 18 mcg increments, resulting in four cohorts of 18, 36, 54, and 72 mcg doses. Decisions to escalate to the next dose cohort will be based upon the data from the previous completed lower dose cohort of four subjects. Approximately 16 subjects are expected to receive study drug,and approximately four center in the United States with expertise in IPF will participate in this study.

Interventions: intervention 1: Treprostinil sodium for inhalation
Intervention descriptions: intervention 1: Administration of inhaled treprostinil sodium 0.6 mg/ml in 3mL ampoules Duration of Treatment: single dose

Dose:

* Cohort 1: dosed at 3 breaths (18 mcg)
* Cohort 2: dosed at 6 breaths (36 mcg)
* Cohort 3: dosed at 9 breaths (54 mcg)
* Cohort 4: dosed at 12 breaths (72 mcg)

The decision to advance to the next cohort will be made after review of all safety information including vital signs, physical examination, clinical laboratory tests, ECGs, and adverse events.

Protocol documents:
Clinical trial NCT00704262
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2008-05-01; Completion date: 2009-12-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to monitor the effect of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g on the hypothalamic-pituitary-adrenal axis and on the calcium metabolism in patients with psoriasis vulgaris on the face and on the intertriginous areas

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Calcipotriol plus hydrocortisone (LEO 80190)
Intervention descriptions: intervention 1: Once daily application

Protocol documents:
Clinical trial NCT00704418
Conditions: Cataract
Keywords: Cataract extraction intraocular lens implantation
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-06-01; Completion date: 2009-12-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Detailed description:

Arms: arm 1: Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily arm 2: Placebo, dosed 1 drop daily
Interventions: intervention 1: Bromfenac intervention 2: Placebo
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution

Protocol documents:
Clinical trial NCT00706004
Conditions: Constipation Cystic Fibrosis
Keywords: constipation cystic fibrosis lubiprostone Constipation in adults with cystic fibrosis
Sponsor: University of Arkansas
Start date: 2008-07-01; Completion date: 2009-12-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.

Detailed description:
Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) and has the potential to be an effective treatment for constipation in adults with CF. It has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on CFTR. This project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with CF with constipation. The specific aims are as follows: 1) Determine the effectiveness of lubiprostone for constipation in participants with CF, and 2) Determine the short term safety of lubiprostone in adults with CF. Data will also be collected to generate further information about the effect of lubiprostone on nutritional status.

Interventions: intervention 1: lubiprostone
Intervention descriptions: intervention 1: lubiprostone 24 microgram capsule taken twice daily for 4 weeks

Protocol documents:
Clinical trial NCT00709696
Conditions: Nicotine Dependence
Keywords: Tobacco nicotine smoking varenicline human laboratory study stress tolerance startle response cognitive assessment progressive ratio
Sponsor: University of Minnesota
Start date: 2008-04-01; Completion date: 2009-12-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the ways that a drug called varenicline helps smokers to quit smoking. Varenicline is also called Chantix® and is approved by the United States Food and Drug Administration (FDA) to help people quit smoking. We will test how varenicline works by having you quit smoking and complete tasks that assess how you think and feel. We predict that varenicline help reduce anxiety, improve attention and concentration, and reduce how satisfying cigarettes are.

Detailed description:
The purpose of this study is to understand the therapeutic mechanisms of varenicline, a novel nicotinic analogue, through focused measures of potential psychological and physiological mediators. Varenicline is an FDA-approved pharmacotherapy for smoking cessation that is believed to provide relief from craving and withdrawal through agonism and antagonism of some central nervous system nicotinic acetylcholinergic receptors. However, no controlled studies have established the physiological and psychological processes that mediate the efficacy of varenicline in humans. The main goal of the proposed pilot study is to evaluate and compare the effects of varenicline on subjective, cognitive, and physiological outcomes, using a randomized, placebo-controlled, double-blind between-groups design. The study will combine both brief clinical trial methodology with human laboratory approaches. A secondary goal is to validate the utility of the laboratory paradigms for the identification of future smoking cessation agents.

Arms: arm 1: Placebo Varenicline arm 2: Varenicline
Interventions: intervention 1: Placebo intervention 2: Varenicline
Intervention descriptions: intervention 1: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.). intervention 2: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).

Protocol documents:
Clinical trial NCT00735449
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2008-07-01; Completion date: 2009-12-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%) arm 2: Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Interventions: intervention 1: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% intervention 2: timolol maleate 0.5% intervention 3: latanoprost 0.005%
Intervention descriptions: intervention 1: 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. intervention 2: 1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. intervention 3: 1 drop of latanoprost 0.005% once nightly.

Protocol documents:
Clinical trial NCT00738023
Conditions: Type 2 Diabetes Hypertension
Keywords: diabetes, hypertension, free-fatty acids
Sponsor: Emory University
Start date: 2004-03-01; Completion date: 2009-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes, dyslipidemia, and hemostatic disorders. Recent evidence suggests that increased levels of free fatty acids (FFA) in obese subjects is a leading candidate in the pathogenesis of insulin resistance (1-4). In our preliminary studies on the effect of FFA on insulin secretion and action (lipotoxicity), we have observed that the infusion of Intralipid/heparin to increase FFA \~ four-fold-baseline levels for 48 hours results in a significant and reproducible raise in systolic and diastolic blood pressure (BP) in obese African American subjects with and without diabetes. The increase in blood pressure is apparent after 12 hours of infusion, reaching a peak increment of 32 mm Hg in systolic and 14 mm Hg in diastolic pressure at 24 hours. These preliminary findings indicate that, in addition to the well-known effect on insulin resistance, sustained elevation of FFA results in the development of an acute metabolic syndrome.

Detailed description:
The FFA-induced hypertension constitutes a useful model with which to examine disease mechanisms and test new therapeutic interventions to correct the different disorders associated with insulin resistance and metabolic syndrome. The effect of FFA on insulin action is well established (4-6); however, the pressor effect of FFA infusion in obese subjects has not been investigated. We hypothesize that observed changes in blood pressure is the result of acute endothelial dysfunction due to increased FFA concentration; and that rosiglitazone, a PPAR gamma receptor agonist, will protect against FFA-induced elevation in blood pressure and endothelial dysfunction in obese subjects.

Arms: arm 1: Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours arm 2: Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
Interventions: intervention 1: Rosiglitazone intervention 2: Normal saline 0.9% intervention 3: Intralipid 20%
Intervention descriptions: intervention 1: Diabetic subjects will be receive rosiglitazone for 6 weeks intervention 2: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours intervention 3: Intralipid 20% at 40ml/hr intravenously for 48 hours

Protocol documents: