ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00259090
Conditions: Breast Cancer
Sponsor: AstraZeneca
Start date: 2004-04-01; Completion date: 2008-10-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.

Detailed description:

Arms: arm 1: Anastrozole Monotherapy arm 2: Fulvestrant Monotherapy arm 3: Anastrozole + Fulvestrant
Interventions: intervention 1: Fulvestrant intervention 2: Anastrazole
Intervention descriptions: intervention 1: 500 mg intramuscular injection intervention 2: oral tablet

Protocol documents:
Clinical trial NCT00264797
Conditions: ADHD Substance Abuse
Sponsor: University of Cincinnati
Start date: 2006-02-01; Completion date: 2008-10-01
Enrollment: 303 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.

Detailed description:
Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. Although research indicates that the majority are not treated for ADHD while in substance treatment, we do not know whether concurrent pharmacotherapy for ADHD will improve treatment outcomes. This Clinical Trials Network (CTN) study will evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH), relative to placebo, in treating ADHD and decreasing substance use in adolescents (13-18 years old) with ADHD and a substance use disorder. Approximately 300 participants will be recruited at 11 sites and randomly assigned to either OROS-MPH or matching placebo for a 16-week treatment period, during which all participants will receive individual cognitive-behavioral therapy as a standardized treatment for substance abuse.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Methylphenidate (OROS-MPH) intervention 2: Methylphenidate (OROS-MPH) - Placebo
Intervention descriptions: intervention 1: Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use. intervention 2: Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.

Protocol documents:
Clinical trial NCT00272779
Conditions: HIV Infections
Keywords: HIV Treatment Naive
Sponsor: Bristol-Myers Squibb
Start date: 2005-11-01; Completion date: 2008-10-01
Enrollment: 1057 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

Detailed description:

Arms: arm 1: Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks. arm 2: Participants were administered an oral dose of LPV 400 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of LPV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.
Interventions: intervention 1: ATV intervention 2: RTV intervention 3: Tenofovi-Emtricitabine (TDF/FTC) tablet intervention 4: LPV
Intervention descriptions: intervention 1: 300mg Oral capsules for 96 weeks intervention 2: 100mg Oral Capsules for 96 weeks intervention 3: One tablet with 300 mg - 200 mg once a day for 96 weeks. intervention 4: 400 mg (3 133mg capsules) BID for 96 weeks

Protocol documents:
Clinical trial NCT00281671
Conditions: Heart Defects, Congenital Cardiopulmonary Bypass
Keywords: Nesiritide Natriuretic Peptide, Brain Heart Defects, Congenital Cardiopulmonary Bypass Diuretics
Sponsor: Boston Children's Hospital
Start date: 2006-04-08; Completion date: 2008-10-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.

Detailed description:
Nesiritide, a recombinant human B-type natriuretic peptide, has vasodilatory, lusitropic and diuretic properties in healthy humans, and improves hemodynamics and symptoms in adults with decompensated congestive heart failure. Several retrospective case series suggest that nesiritide has beneficial effects on hemodynamics and urine output in adults and children following cardiac surgery.

The purpose of this prospective, randomized, double-blind, crossover study is to evaluate the effects of a continuous infusion of nesiritide on postoperative hemodynamics and urine output in infants with congenital heart disease who undergo cardiac surgery requiring cardiopulmonary bypass (CPB). Patients less than 1 year of age following cardiac surgery will be eligible for the study if they have received two conventional diuretics (furosemide and chlorothiazide) for at least 12 hours, yet are not effectively achieving a negative fluid balance, thus prohibiting sternal closure or tracheal extubation. Patients will be randomized to receive either a 10-hour infusion of nesiritide, a two hour washout period, followed by a 10-hour infusion of placebo, or this study drug sequence in reverse order. During the 24-hour study period, serial cardiac output measurements and BNP levels will be obtained, vital signs and intracardiac filling pressures will be recorded, and urine output will be measured.

Arms: arm 1: In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. arm 2: In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.
Interventions: intervention 1: nesiritide intervention 2: Placebo
Intervention descriptions: intervention 1: nesiritide 0.015 mcg/kg/hour x 10 hours intervention 2: 0.9% sodium chloride infusion

Protocol documents:
Clinical trial NCT00282243
Conditions: Liver Transplantation
Keywords: Pharmacokinetics Therapy Immunosuppression Drugs, Investigational Adult
Sponsor: Astellas Pharma Inc
Start date: 2003-02-01; Completion date: 2008-10-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Detailed description:
A one arm study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Arms: arm 1: After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.

Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons.
Interventions: intervention 1: tacrolimus modified release (MR) intervention 2: tacrolimus
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT00282256
Conditions: Liver Transplantation
Keywords: Child Pharmacokinetics Immunosuppression Drugs Hepatic transplant Liver Transplantation
Sponsor: Astellas Pharma Inc
Start date: 2004-01-01; Completion date: 2008-10-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Detailed description:
A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen.

Arms: arm 1: Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
Interventions: intervention 1: tacrolimus modified release (MR) intervention 2: tacrolimus
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT00291135
Conditions: Breast Cancer
Keywords: breast atypia open label pilot study letrozole fine needle aspiration high risk for breast cancer breast epithelial hyperplasia Ki-67 hormones plus chemoprevention chemoprevention
Sponsor: Carol Fabian, MD
Start date: 2003-01-01; Completion date: 2008-10-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

Detailed description:
A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.

Arms: arm 1: Oral Letrozole 2.5 mg daily for six months
Interventions: intervention 1: letrozole
Intervention descriptions: intervention 1: Letrozole 2.5 mg daily

Protocol documents:
Clinical trial NCT00303329
Conditions: Anemia Hemosiderosis
Keywords: β-thalassemia rare chronic anemia iron overload deferasirox chronic anemias transfusional hemosiderosis
Sponsor: Novartis Pharmaceuticals
Start date: 2004-03-01; Completion date: 2008-10-01
Enrollment: 184 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed the main trial may continue in the extension trial to receive chelation therapy with deferasirox for up to 3 years. Extension was prolonged to 4 years.

The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.

Detailed description:

Arms: arm 1: Deferasirox daily oral dose between 5-40 mg/kg/day
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: Deferasirox available as 125 mg, 250 mg or 500 mg tablets

Protocol documents:
Clinical trial NCT00320528
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Eli Lilly and Company
Start date: 2006-04-01; Completion date: 2008-10-01
Enrollment: 269 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.

Detailed description:

Arms: arm 1: Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks arm 2: Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks arm 3: Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Interventions: intervention 1: atomoxetine
Intervention descriptions: intervention 1: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Protocol documents:
Clinical trial NCT00323362
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer stage IV non-small cell lung cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2006-04-01; Completion date: 2008-10-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the response rate in patients with recurrent or metastatic non-small cell lung cancer treated with gemcitabine hydrochloride and imatinib mesylate.

Secondary

* Assess time to progression in patients treated with this regimen.
* Assess overall survival and 1-year survival of patients treated with this regimen.
* Assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, nonrandomized, uncontrolled, open-label study.

Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: gemcitabine hydrochloride intervention 2: imatinib mesylate
Intervention descriptions: intervention 1: 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days. intervention 2: 400 mg/day orally, given Days 1-5 and 8-12 every 21 days

Protocol documents:
Clinical trial NCT00329433
Conditions: Deep Venous Thrombosis
Keywords: Deep venous thrombosis DVT Heparin induced thrombocytopenia HIT Direct thrombin inhibitor
Sponsor: Washington University School of Medicine
Start date: 2006-05-01; Completion date: 2008-10-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.

Detailed description:

Arms: arm 1: Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100). arm 2: Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.
Interventions: intervention 1: Desirudin (Iprivask™) intervention 2: Heparin
Intervention descriptions: intervention 1: Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points. intervention 2: The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).

Protocol documents:
Clinical trial NCT00335478
Conditions: Fever Sweating Hot Flashes Infection Neutropenia Unspecified Adult Solid Tumor, Protocol Specific
Keywords: neutropenia infection unspecified adult solid tumor, protocol specific fever, sweats, and hot flashes
Sponsor: OHSU Knight Cancer Institute
Start date: 2006-12-01; Completion date: 2008-10-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer.

PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.

Detailed description:
OBJECTIVES:

Primary

* Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever.

Secondary

* Assess the percentage of bacterial cures in patients with documented gram-positive bacterial infections.
* Assess time to afebrile state.
* Assess the pharmacokinetic data of daptomycin in neutropenic patients.
* Document the incidence of breakthrough infections that require a change of therapy or additional agents to clear.
* Assess the tolerability of daptomycin in neutropenic patients.
* Assess and document adverse events and toxicity due to daptomycin.

OUTLINE: This is an open-label, pilot study.

Patients first receive standard treatment for gram-negative bacteria for 72 hours. If the patient is still febrile at 72 hours, daptomycin is administered.

Patients receive daptomycin IV over 30 minutes once daily. Patients who are afebrile, not neutropenic (absolute neutrophil count \[ANC\] \> 500/mm³), and have no signs of infection after 72 hours of therapy may discontinue daptomycin. Patients who are afebrile and neutropenic (ANC \< 500/mm³) after 72 hours of therapy continue to receive daptomycin until absolute neutrophil count (ANC) \> 500/mm³ for 2 consecutive days. Patients who are febrile with or without continued neutropenia (ANC \< 500/mm³) after 72 hours of therapy continue to receive daptomycin for up to 10-14 days in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: Daptomycin
Intervention descriptions: intervention 1: daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is \>500 cells/mm\^3.

Protocol documents:
Clinical trial NCT00337779
Conditions: Relapsing Remitting Multiple Sclerosis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2006-08-01; Completion date: 2008-10-01
Enrollment: 1155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties. The study treatment duration is 12 months.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Glatiramer Acetate (GA) 40 mg intervention 2: glatiramer acetate 20 mg
Intervention descriptions: intervention 1: Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months intervention 2: Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months

Protocol documents: