ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01005888
Conditions: Hereditary Angioedema
Keywords: Hereditary angioedema HAE C1 esterase inhibitor (human) C1INH-nf
Sponsor: Shire
Start date: 2005-03-14; Completion date: 2007-08-22
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.

Detailed description:
Subjects were given diary cards and instructed to document all HAE attacks on a daily basis. Subjects evaluated their symptoms over the previous 24 hours, noting the severity and duration of swelling at each of 5 locations (abdominal, genitourinary, facial, respiratory \[including laryngeal\], and/or extremity).

The study design also allowed for administration of open-label C1INH-nf (1,000 U of C1INH-nf administered IV \[repeated after 60 minutes, if necessary\] for treatment of laryngeal angioedema or if deemed necessary by the investigator; 1,000 U of C1INH-nf administered IV \[single dose\] prior to emergency surgical procedures).

A total of 26 subjects were enrolled in the study. One subject received open-label C1INH-nf but withdrew prior to randomization. Another subject was randomized but withdrew prior to receiving study drug. Twenty-four (24) subjects were randomized and treated with blinded study drug. In total, 25 subjects received at least 1 dose of study drug and were analyzed for safety; all 25 subjects were exposed to C1INH-nf and 23 subjects were exposed to placebo.

Arms: arm 1: 1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks. arm 2: Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
Interventions: intervention 1: C1 esterase inhibitor [human] (C1INH-nf) intervention 2: Placebo (saline)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00268996
Conditions: Atherosclerosis
Keywords: Coronary artery disease Lipoprotein-associated Phospholipase A2 palpography hs-CRP endothelial function intravascular ultrasound
Sponsor: GlaxoSmithKline
Start date: 2005-11-10; Completion date: 2007-08-28
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.

Detailed description:
Integrated Biomarker and Imaging Study -2 (IBIS-2): An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects with Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability.

Arms: arm 1: Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks arm 2: Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks arm 3: Enrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks arm 4: Enrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks
Interventions: intervention 1: SB-480848 intervention 2: SB-480848 matching placebo
Intervention descriptions: intervention 1: SB-480848 is available as enteric-coated, free-base micronized tablet intervention 2: Placebo is available as enteric-coated, free-base micronized tablet

Protocol documents:
Clinical trial NCT00065182
Conditions: Lung Cancer, Non-Small Cell Non-Small-Cell Lung Cancer
Keywords: HYCAMTIN TAXOTERE non-small cell lung cancer NSCLC docetaxel topotecan Stage IIIB/IV Advanced
Sponsor: GlaxoSmithKline
Start date: 2003-08-14; Completion date: 2007-08-30
Enrollment: 399 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.

Detailed description:

Interventions: intervention 1: Topotecan/Docetaxel combination intervention 2: Docetaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00039871
Conditions: Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2002-05-01; Completion date: 2007-09-01
Enrollment: 2333 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 2: REBETOL (ribavirin; SCH 18908)
Intervention descriptions: intervention 1: PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks intervention 2: REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

Protocol documents:
Clinical trial NCT00107653
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2004-10-01; Completion date: 2007-09-01
Enrollment: 569 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

Detailed description:

Arms: arm 1: Participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening). arm 2: Participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Interventions: intervention 1: Ribavirin intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin intervention 4: Peginterferon alfa-2a
Intervention descriptions: intervention 1: 1000-1200mg po daily for 48 weeks intervention 2: 180 micrograms sc/week for 48 weeks intervention 3: 1000-1200mg po daily for 48 weeks intervention 4: 180 micrograms sc/week for 48 weeks

Protocol documents:
Clinical trial NCT00399568
Conditions: Postoperative Pain Hysterectomy
Keywords: Pain Gynecologic IV Acetaminophen Postoperative Analgesic
Sponsor: Mallinckrodt
Start date: 2006-11-01; Completion date: 2007-09-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.

Detailed description:
The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: IV Acetaminophen intervention 2: IV Placebo 100 mL solution
Intervention descriptions: intervention 1: Intravenous acetaminophen 1 g/100 mL intervention 2: IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)

Protocol documents:
Clinical trial NCT00003459
Conditions: Brain Stem Gliomas
Keywords: recurrent adult brain stem glioma untreated adult brain stem glioma untreated childhood brain stem glioma recurrent childhood brain stem glioma
Sponsor: Burzynski Research Institute
Start date: 1996-03-01; Completion date: 2007-09-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) and adults with newly-diagnosed or recurrent brain stem gliomas.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with a brain stem glioma, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with a brain stem glioma.

OVERVIEW: This is a single arm, open-label study in which patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size in measured utilizing MRI scans, which are performed every 8 weeks for the first 2 years, every 3 months for the 3rd and 4th years, every 6 months for the 5th and 6th years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)

Protocol documents:
Clinical trial NCT00003472
Conditions: Oligodendroglioma, Adult
Keywords: Recurrent/progressive adult oligodendroglioma Recurrent/progressive adult anaplastic oligodendroglioma
Sponsor: Burzynski Research Institute
Start date: 1996-05-01; Completion date: 2007-09-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for adult recurrent/progressive oligodendrogliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adult recurrent/progressive oligodendrogliomas.

Detailed description:
OVERVIEW: This is a single arm, open-label study in which adults with recurrent/progressive oligodendrogliomas receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in adults with recurrent/progressive oligodendrogliomas, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in adults with recurrent/progressive oligodendrogliomas.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00096993
Conditions: Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer
Keywords: Omnitarg Cancer Platinum-Resistant
Sponsor: Genentech, Inc.
Start date: 2005-01-01; Completion date: 2007-09-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.

Detailed description:

Arms: arm 1: Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m\^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). arm 2: Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m\^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Interventions: intervention 1: Placebo intervention 2: Gemcitabine intervention 3: Pertuzumab
Intervention descriptions: intervention 1: Placebo was provided as a single-use formulation for infusion. intervention 2: Gemcitabine was provided as a solution for infusion. intervention 3: Pertuzumab was provided as a single-use formulation for infusion.

Protocol documents:
Clinical trial NCT00110890
Conditions: End Stage Renal Disease
Keywords: Secondary HyperParaThyroidism (SHPT) Dialysis, End Stage Renal Disease (ESRD) KDOQI, Cinacalcet Clinical Trial, Amgen
Sponsor: Amgen
Start date: 2004-05-01; Completion date: 2007-09-01
Enrollment: 552 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.

Detailed description:

Arms: arm 1: Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets. arm 2: Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on iPTH values.
Interventions: intervention 1: cinacalcet intervention 2: Standard of care
Intervention descriptions: intervention 1: Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. intervention 2: Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.

Protocol documents:
Clinical trial NCT00124735
Conditions: Anesthesia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-10-01; Completion date: 2007-09-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to \<28 days old), infants (28 days to \<=3 months) and toddlers (\>3 months to \<=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (\>11 years to less than or equal to 17 years of age).

Detailed description:

Arms: arm 1: Rocuronium bolus maintenance arm 2: Rocuronium continuous infusion maintenance
Interventions: intervention 1: Rocuronium bolus maintenance intervention 2: rocuronium continuous infusion maintenance
Intervention descriptions: intervention 1: Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation intervention 2: Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation

Protocol documents:
Clinical trial NCT00158600
Conditions: Pompe Disease (Late-onset) Glycogen Storage Disease Type II (GSD-II) Acid Maltase Deficiency Disease Glycogenosis 2
Keywords: Glycogen Storage Disease Type II GSD-II Pompe Disease
Sponsor: Genzyme, a Sanofi Company
Start date: 2005-09-01; Completion date: 2007-09-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective is to evaluate the safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa treatment in patients with late-onset Pompe disease as compared to placebo.

Detailed description:

Arms: arm 1: Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks. arm 2: Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
Interventions: intervention 1: alglucosidase alfa intervention 2: Placebo
Intervention descriptions: intervention 1: IV infusion of 20mg/kg; qow for 78 weeks. intervention 2: Placebo Comparator; qow for 78 weeks.

Protocol documents:
Clinical trial NCT00186446
Conditions: Major Depressive Disorder Nicotine Dependence
Sponsor: Stanford University
Start date: 2004-06-01; Completion date: 2007-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.

Detailed description:
The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.

Arms: arm 1: None
Interventions: intervention 1: bupropion and smoking cessation behavioral intervention
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00246090
Conditions: Breast Cancer
Sponsor: Eisai Inc.
Start date: 2005-10-01; Completion date: 2007-09-01
Enrollment: 298 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who are refractory to the last prior therapy for their disease.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.

Protocol documents: