ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00737711
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-07-01; Completion date: 2009-10-01
Enrollment: 189 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: iv 0.6 micrograms/kg every 2 weeks

Protocol documents:
Clinical trial NCT00738400
Conditions: Erectile Dysfunction Metabolic Syndrome
Keywords: Vardenafil Erectile Dysfunction Double-blind study
Sponsor: Bayer
Start date: 2008-11-01; Completion date: 2009-10-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

Detailed description:

Arms: arm 1: Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks arm 2: Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Interventions: intervention 1: Vardenafil (Levitra, BAY38-9456) intervention 2: Placebo
Intervention descriptions: intervention 1: Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks intervention 2: Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks

Protocol documents:
Clinical trial NCT00740779
Conditions: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Keywords: prostatitis, chronic pelvic pain
Sponsor: Watson Pharmaceuticals
Start date: 2008-09-01; Completion date: 2009-10-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.

Detailed description:
A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Arms: arm 1: 4 mg daily arm 2: Silodosin 8 mg daily arm 3: 1 placebo capsule daily
Interventions: intervention 1: Silodosin 8 mg intervention 2: Placebo intervention 3: Silodosin 4 mg
Intervention descriptions: intervention 1: Silodosin 8 mg daily intervention 2: Placebo intervention 3: Silodosin 4 mg daily

Protocol documents:
Clinical trial NCT00749190
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-08-01; Completion date: 2009-10-01
Enrollment: 495 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Detailed description:

Interventions: intervention 1: BI 10773 intervention 2: placebo intervention 3: sitagliptin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00755417
Conditions: Hot Flashes
Keywords: Hot flashes Hot flushes Postmenopausal symptoms Vasomotor symptoms
Sponsor: Depomed
Start date: 2008-09-01; Completion date: 2009-10-01
Enrollment: 541 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.

Detailed description:
The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:

* G-ER 1200 mg daily (single evening dose)
* G-ER 1800 mg daily (dosed asymmetrically; 600 mg in AM/1200 mg in PM) compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a stable dose, compared with the baseline week.

Arms: arm 1: Gabapentin extended-release (G-ER) 1200 mg arm 2: Gabapentin extended-release (G-ER) 1800 mg arm 3: Placebo 1200 mg or 1800 mg
Interventions: intervention 1: Gabapentin Extended-Release (G-ER) 1200 mg intervention 2: Gabapentin Extended-Release (G-ER) 1800 mg intervention 3: Placebo
Intervention descriptions: intervention 1: G-ER 1200 mg daily dosage given as two 600-mg tablets. intervention 2: G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening. intervention 3: Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).

Protocol documents:
Clinical trial NCT00779701
Conditions: Hyperglycemia
Keywords: Hyperglycemia Glycemic control
Sponsor: Temple University
Start date: 2007-03-01; Completion date: 2009-10-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion protocols are routinely used in the ICU setting. The investigators plan to establish the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED setting. The investigators propose to study the aspects of implementing a strict glycemic control protocol in the ED.

Detailed description:

Arms: arm 1: All subjects placed on insulin infusion.
Interventions: intervention 1: Insulin
Intervention descriptions: intervention 1: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL

Protocol documents:
Clinical trial NCT00782834
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST Nilotinib
Sponsor: Fox Chase Cancer Center
Start date: 2008-07-01; Completion date: 2009-10-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study of Nilotinib for patients with advanced GIST that cannot be surgically removed. Patients are candidates for the study if their tumors have progressed on imatinib and sunitinib or if they were intolerant to these drugs. Patients may have received other investigational therapies as well. We are testing the benefit of nilotinib in advanced GIST looking at the length of time disease is controlled as well as the response of the disease to the drug.

Detailed description:
Nilotinib is an oral drug. The dose is 400 mg twice daily

Patients are evaluated every 8 weeks for disease response. Blood work is assessed for safety initially weekly, then every 4 weeks. Physical exams are performed initially weekly and then decreased to every 4 weeks after the first month.

Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: 400 mg orally twice daily until disease progression, intolerability or withdrawal of consent

Protocol documents:
Clinical trial NCT00784719
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Sponsor: Pfizer
Start date: 2008-11-01; Completion date: 2009-10-01
Enrollment: 327 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: Cyclosporine intervention 6: CP-690,550 Vehicle
Intervention descriptions: intervention 1: Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks intervention 2: Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks intervention 3: Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks intervention 4: Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks intervention 5: Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks intervention 6: Ophthalmic topical solution, dosed at least once/day, 8 weeks

Protocol documents:
Clinical trial NCT00789035
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-10-01; Completion date: 2009-10-01
Enrollment: 408 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed

Detailed description:

Interventions: intervention 1: BI 10773 intervention 2: placebo intervention 3: metformin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00793819
Conditions: Nocturia Prostatic Hyperplasia
Keywords: nocturia BPH benign prostate hyperplasia nocturia in men with benign prostate hyperplasia
Sponsor: Watson Pharmaceuticals
Start date: 2009-01-01; Completion date: 2009-10-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Detailed description:
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Arms: arm 1: None arm 2: None
Interventions: intervention 1: silodosin
Intervention descriptions: intervention 1: α1-adrenergic antagonist

Protocol documents:
Clinical trial NCT00794157
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD chronic obstructive pulmonary disease indacaterol long acting β2-agonist
Sponsor: Novartis Pharmaceuticals
Start date: 2008-11-01; Completion date: 2009-10-01
Enrollment: 347 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.

Detailed description:

Arms: arm 1: Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 3: Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol 150 μg capsules intervention 2: Indacaterol 300 μg capsules intervention 3: Placebo capsules
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 2: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 3: Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Protocol documents:
Clinical trial NCT00799604
Conditions: Hypertension
Keywords: Hypertension Antihypertensive Agent Calcium Channel Blocker
Sponsor: The Medicines Company
Start date: 2008-11-01; Completion date: 2009-10-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.

Detailed description:
Study participants were screened up to 14 days prior to their elective cardiac surgery. For the purpose of this study, hypertension was defined as systolic blood pressure (SBP) ≥140 mm Hg immediately prior to initiation of study drug.

On the day of surgery, an IV bolus dose of clevidipine (Bolus 1 - pre-anesthesia) was administered to each eligible study participant during Treatment Period 1 to decrease BP before induction of general anesthesia. The dose (either 125 μg, 250 μg or 500 μg) given was based on the assigned cohort for each participant, listed in the 'Arms' section below.

At the discretion of the investigator, a second IV bolus dose of clevidipine (Bolus 2 - with anesthesia) could have been administered during Treatment Period 2 at either 125 μg, 250 μg or 500 μg, based upon the earlier observed response to Bolus 1. This dose was administered after the induction of anesthesia, to decrease BP prior to cannulation of the ascending aorta for initiation of cardiopulmonary bypass.

Assessment of safety was performed throughout Treatment Periods 1 and 2 with Adverse Events (AEs) followed 6 hours post final bolus dose and Serious Adverse Events (SAEs) followed 24 hours post final bolus dose.

Arms: arm 1: Patients were sequentially assigned to one of following three planned dose cohorts for Bolus 1 within the clevidipine arm:

* Cohort 1: clevidipine 250 µg (0.5 mL)
* Cohort 2: clevidipine 500 µg (1 mL)
* Cohort 3: clevidipine 125 µg (0.25 mL or 0.5 mL of a 1:1 solution)
Interventions: intervention 1: clevidipine
Intervention descriptions: intervention 1: Clevidipine (0.5mg/mL in 20% lipid emulsion) was administered as an IV bolus (\<5 sec) by rapid injection for Bolus 1 and for Bolus 2, if second bolus dose was administered, directly into a peripheral venous catheter followed by a normal saline flush (10mL).

Protocol documents:
Clinical trial NCT00800436
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-11-01; Completion date: 2009-10-01
Enrollment: 66 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants. The study will also assess the safety and tolerability of the SC and IV formulations. In Part 1 of the study, four cohorts will be treated with a single dose of Herceptin as follows: Cohort 1 (6 milligrams per kilogram \[mg/kg\] IV in healthy male participants); Cohort 2 (6 mg/kg IV in HER2-positive female participants); Cohort 3 (6 mg/kg SC in healthy male participants); Cohort 4 (10 mg/kg SC in healthy male participants). An additional cohort of healthy volunteers (Cohort 5) will be opened if both SC dose levels from Cohorts 3 and 4 result in Herceptin exposures different from the target concentration produced by a single IV dose, or if the variability in pharmacokinetic (PK) parameter values cannot be used to define the target SC dose level. In Part 2 of the study, HER2-positive female participants will receive a single dose of SC Herceptin at the dose level defined in Part 1. Participants from Part 1 are eligible to enter Part 2 provided they receive the second (Part 2) study dose of Herceptin a minimum of 22 days after their first (Part 1) dose.

Detailed description:

Arms: arm 1: Healthy male participants will receive Herceptin 6 mg/kg IV on Day 1. arm 2: Female participants with HER2-positive breast cancer will receive Herceptin 6 mg/kg IV on Day 1. arm 3: Healthy male participants will receive Herceptin 6 mg/kg SC on Day 1. arm 4: Healthy male participants will receive Herceptin 10 mg/kg SC on Day 1. arm 5: Healthy male participants will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohorts 1, 2, 3, and 4. arm 6: Female participants with HER2-positive breast cancer will receive Herceptin SC at the dose level determined in Part 1. arm 7: Female participants with HER2-positive breast cancer will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohort A.
Interventions: intervention 1: Herceptin
Intervention descriptions: intervention 1: Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Protocol documents:
Clinical trial NCT00805025
Conditions: Bronchiectasis
Sponsor: Gilead Sciences
Start date: 2008-12-01; Completion date: 2009-10-01
Enrollment: 89 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points during the study, in additional to pulmonary function testing and other standard procedures.

Detailed description:

Arms: arm 1: Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
Interventions: intervention 1: AZLI
Intervention descriptions: intervention 1: 75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily using the PARI Investigational eFlow® Nebulizer System (with a minimum of 4 hours between doses) following administration of a short-acting bronchodilator

Protocol documents:
Clinical trial NCT00807092
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-12-01; Completion date: 2009-10-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.

Detailed description:

Arms: arm 1: BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred. arm 2: BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: biphasic human insulin 30 intervention 3: metformin
Intervention descriptions: intervention 1: The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner intervention 2: The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner intervention 3: Metformin dose must remain the same as that used prior to the trial.

Protocol documents: