ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00541658
Conditions: Postmenopausal Osteoporosis
Sponsor: Warner Chilcott
Start date: 2007-10-01; Completion date: 2010-04-01
Enrollment: 923 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly 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 35 mg delayed release given weekly and 5 mg immediate release given daily.

Arms: arm 1: 5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast) arm 2: 35 mg / Delayed-release Risedronate (Immediately Following Breakfast) arm 3: 35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)
Interventions: intervention 1: risedronate intervention 2: risedronate intervention 3: risedronate
Intervention descriptions: intervention 1: 5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily intervention 2: 35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly intervention 3: 35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly

Protocol documents:
Clinical trial NCT00566501
Conditions: Alzheimer's Disease
Keywords: Moderate-to-severe Alzheimer's Disease
Sponsor: Eisai Inc.
Start date: 2007-12-14; Completion date: 2010-04-01
Enrollment: 915 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse events (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label extension study.

Detailed description:

Arms: arm 1: Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205). arm 2: Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg immediate release (IR) in the preceding double-blind study E2020-G000-326 (NCT00478205).
Interventions: intervention 1: Donepezil
Intervention descriptions: intervention 1: Donepezil SR 23 mg once daily orally.

Protocol documents:
Clinical trial NCT00567476
Conditions: Asthma
Keywords: Asthma, anti-immunoglobulin E, omalizumab
Sponsor: Novartis
Start date: 2007-11-01; Completion date: 2010-04-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigated asthma-related quality of life in Brazilian patients using omalizumab.

Detailed description:

Arms: arm 1: Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit. arm 2: Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Interventions: intervention 1: Omalizumab intervention 2: Inhaled corticosteroids (ICS) intervention 3: Long-acting beta 2-adrenergic agonist (LABA) intervention 4: Short-acting beta 2-adrenergic agonist (SABA)
Intervention descriptions: intervention 1: Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE. intervention 2: Any ICS with proprietary drug and device \> 500 mcg of fluticasone or equivalent intervention 3: Fixed dose of LABA as prescribed prior to study entry intervention 4: Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.

Protocol documents:
Clinical trial NCT00576056
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular Carcinoma TACE Sorafenib Transcatheter Arterial Chemoembolization Nexavar Unresectable
Sponsor: University of Pittsburgh
Start date: 2008-01-01; Completion date: 2010-04-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery.

Detailed description:
The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC, but this will also be the first clinical trial with sorafenib to assess the effects of this novel therapy on HRQL. Understanding the effects of sorafenib on HRQL is critical in the treatment of HCC secondary to the modest benefits in survival that have been reported with conventional therapies. Our team has one of the largest experiences in evaluating HRQL in patients diagnosed with unresectable hepatocellular carcinoma. We have previously reported on alternative methods of evaluating HRQL, solutions for missing data in clinical trials as well as tested statistical and clinically meaningful differences, within and between treatment groups, in clinical trials with patients diagnosed with hepatobiliary carcinoma.

Arms: arm 1: Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
Interventions: intervention 1: Sorafenib intervention 2: TACE
Intervention descriptions: intervention 1: Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination. intervention 2: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin.

Protocol documents:
Clinical trial NCT00578734
Conditions: Acute Hypoxemic Respiratory Failure
Sponsor: Windtree Therapeutics
Start date: 2007-06-01; Completion date: 2010-04-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).

Detailed description:
Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.

Arms: arm 1: SURFAXIN® (lucinactant) for intratracheal instillation arm 2: Sham air (placebo) instillation
Interventions: intervention 1: Lucinactant intervention 2: Sham Comparator
Intervention descriptions: intervention 1: Slow intra-tracheal instillation intervention 2: Slow intra-tracheal instillation

Protocol documents:
Clinical trial NCT00592683
Conditions: Pediatric Bipolar Disorder
Keywords: bipolar disorder fish oil aripiprazole children
Sponsor: Massachusetts General Hospital
Start date: 2007-12-01; Completion date: 2010-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as follows:

Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of children and adolescents with BPD

Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active omega-3 treatment

Detailed description:
Initial clinical evidence suggests that the omega-3 fatty acids EPA (eicosapentaenoic acid) and/or DHA (docosahexaenoic acid) may play a therapeutic role in the management of mood disorders. EPA is an essential fatty acid, which can be metabolized to DHA and is a component of the human diet if fish is consumed. Aripiprazole is a novel second general antipsychotic that seems to function as a partial agonist at the dopamine D2 and serotonin 5-HT 1A receptors as well as an antagonist at the serotonin 5-HT 2A receptor. Since it has a favorable adverse event profile in adults, it is an attractive choice for the treatment of youth with bipolar disorder if proven efficacious. Although pilot research showed that omega-3 fatty acids monotherapy treatment resulted in improvement of manic symptoms, the improvement is less dramatic than that observed in trials of antipsychotics. We will test the safety and efficacy of omega-3 fatty acids versus placebo as an adjunctive treatment to open-label aripiprazole in children and adolescents with bipolar disorder.

The proposed study includes 1) the use of a 12-week design to document the response rate 2) careful assessment of safety and tolerability

Arms: arm 1: Subjects administered aripiprazole and randomized to receive fish oil arm 2: Subjects administered aripiprazole and randomized to receive placebo
Interventions: intervention 1: Aripiprazole intervention 2: fish oil intervention 3: Placebo
Intervention descriptions: intervention 1: tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks intervention 2: 1600mg (4 capsules) daily for 12 weeks intervention 3: Placebo

Protocol documents:
Clinical trial NCT00594620
Conditions: Prostate Cancer
Sponsor: University of Kansas Medical Center
Start date: 2004-08-01; Completion date: 2010-04-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer

Detailed description:
Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.

Arms: arm 1: Subjects receive supplement arm 2: Subjects will receive placebo
Interventions: intervention 1: Flav-ein capsules intervention 2: Placebo
Intervention descriptions: intervention 1: Soy/isoflavone supplementation intervention 2: Placebo

Protocol documents:
Clinical trial NCT00599326
Conditions: Porphyria Cutanea Tarda
Keywords: Exjade PCT Study PCT Study Porphyria Cutanea Tarda
Sponsor: University of Texas Southwestern Medical Center
Start date: 2008-01-01; Completion date: 2010-04-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the efficacy and tolerability of deferasirox in the treatment of Porphyria Cutanea Tarda.

Primary objective - the elimination of all blistering within 6 months of treatment.

Secondary objective - decrease in total body iron levels.

Detailed description:
Phlebotomy is the standard therapy for Porphyria Cutanea Tarda (PCT), but it can be inconvenient and cause anemia in some patients.

Deferasirox is a new class of tridentate iron chelators with high affinity and selectivity for iron. The medication is administered orally, which if effective for PCT would make it a more convenient and possibly more tolerable option for patients.

Arms: arm 1: None
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: 250 mg of deferasirox once daily for 6 months

Protocol documents:
Clinical trial NCT00608907
Conditions: Multiple Myeloma Non-Hodgkin's Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2007-09-01; Completion date: 2010-04-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this Phase I study is to evaluate the effect of the co-administration of CYP3A4 inducers on the pharmacokinetics profile of VELCADE (bortezomib). Rifampicin will be used to assess the effect of a strong CYP3A4 inducer and dexamethasone to assess the effect of a relatively weak inducer. This study is also to evaluate the impact of CYP3A4 inducers on the pharmacodynamics (PD) of VELCADE and the safety profile of VELCADE.

Detailed description:

Arms: arm 1: Control arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle. arm 2: Treatment Arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3. arm 3: Treatment arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3.
Interventions: intervention 1: bortezomib intervention 2: bortezomib, rifampicin intervention 3: bortezomib, dexamethasone
Intervention descriptions: intervention 1: 1.3 mg/m\^3 on days 1, 4, 8, 11 over a 21-day treatment cycle intervention 2: bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3 intervention 3: bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3

Protocol documents:
Clinical trial NCT00623545
Conditions: Healthy
Keywords: Exenatide Byetta weight loss energy expenditure normal volunteers
Sponsor: University of Wisconsin, Madison
Start date: 2008-01-01; Completion date: 2010-04-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out how exenatide causes weight loss. Specifically, the study is assessing how exenatide may change how people take in energy (energy intake), as well as how it may effect how people use energy (energy expenditure).

Detailed description:
The bioenergetics study is looking at how and why the diabetes drug exenatide causes people to lose weight.Bioenergetics is the study of how your body burns calories.

Adults 18-65 who do not have diabetes and have a body mass index (BMI) between 30 and 40 may be eligible. Women who could get pregnant must be on birth control during the study and women who are pregnant cannot participate in the study.

Subjects will take exenatide for 12 weeks. There are 6 study visits in the Univ. Wisconsin Hospital General Clinical Research Center. Visits range from 1 to 6 hours and include blood and urine tests, resting metabolic rate testing over a four hour period, physical exam, ECG, and a be bone mineral density testing at another clinic during 2 clinic visits of the study.

All study procedures and testing are free of charge.

Arms: arm 1: Exenatide. Dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks Each subject serves as their own control for outcome measures taken before and during drug treatment.
Interventions: intervention 1: Exenatide
Intervention descriptions: intervention 1: Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.

Protocol documents:
Clinical trial NCT00637923
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C, Chronic
Sponsor: Romark Laboratories L.C.
Start date: 2008-03-01; Completion date: 2010-04-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.

Detailed description:

Arms: arm 1: One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. arm 2: One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Interventions: intervention 1: Nitazoxanide intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. intervention 2: One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. intervention 3: One weekly injection of 180µg of peginterferon α-2a for 48 weeks. intervention 4: Weight-based ribavirin for 48 weeks.

Protocol documents:
Clinical trial NCT00644969
Conditions: Smoking Cessation
Sponsor: Pfizer
Start date: 2008-05-01; Completion date: 2010-04-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.

Detailed description:
This is a safety study.

Arms: arm 1: Randomization 2:1 treatment to placebo arm 2: None
Interventions: intervention 1: placebo intervention 2: varenicline (CP-526,555)
Intervention descriptions: intervention 1: Randomization 2:1 treatment to placebo intervention 2: One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid

Protocol documents:
Clinical trial NCT00652028
Conditions: Intubated and Mechanically Ventilated Pediatric Subjects
Keywords: Pharmacokinetics Pharmacodynamics Escalating dose Dexmedotimidine Intubated Mechanically ventilated Pediatrics
Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Start date: 2008-11-01; Completion date: 2010-04-01
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects ages ≥2 through \<17 years old.

Detailed description:
This is a phase II, open-label, multicenter, escalating dose study evaluating the pharmacokinetics and pharmacodynamics of dexmedetomidine in pediatric subjects. The study population consists of initially intubated and mechanically ventilated pediatric subjects, ages ≥2 through \<17 years old, that require sedation in an intensive care setting for a minimum of 6 hours. Subjects will be divided into two groups based on age: Group I will consist of subjects ages ≥2 through \<6 years old and Group II subjects age ≥6 through \<17 years old. Within each group there will be four escalating dosing levels. Both groups can enroll simultaneously; however within each group, the next dose level cannot begin to enroll until all subjects have completed the previous dose level and the Data Safety Monitoring Board (DSMB) has approved enrollment to the next level. The level of sedation will be assessed using the Ramsay Sedation Scale (RSS). Based on these scores, and clinical judgment, additional sedation with midazolam will be administered according to the label. Pain will be assessed using the Faces, Legs, Arms, Cry \& Consolability (FLACC) scale. Venous blood samples for pharmacokinetic analysis will be obtained at designated times. The pharmacodynamic and safety measures that will be monitored and the pharmacodynamic impact of dexmedetomidine on tracheal extubation will also be explored if subject is extubated within 24 hours.

Arms: arm 1: Dose level 1 arm 2: Dose level 2 arm 3: Dose level 3 arm 4: Dose level 4
Interventions: intervention 1: Dexmedetomidine, midazolam; fentanyl
Intervention descriptions: intervention 1: Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label

Protocol documents:
Clinical trial NCT00655668
Conditions: T-cell Non-Hodgkin's Lymphoma
Keywords: NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
Sponsor: Celgene
Start date: 2008-03-01; Completion date: 2010-04-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop.

All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase.

Objectives:

Primary:

• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.

Secondary:

• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.

Detailed description:
Study was terminated. Study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.

Arms: arm 1: Open-label, oral lenalidomide monotherapy
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle

Protocol documents: