ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01104584
Conditions: Breast Cancer
Keywords: Breast Cancer Gadobutrol-enhanced MRI Mammography Diagnostic Imaging
Sponsor: Bayer
Start date: 2010-05-01; Completion date: 2012-01-01
Enrollment: 460 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers

Detailed description:

Arms: arm 1: Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) \[0.1 ml/kg bw\] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: A single bolus injection of gadobutrol 1.0 M; 0.1 mmol/kg body weight

Protocol documents:
Clinical trial NCT01115556
Conditions: Age Related Macular Degeneration
Sponsor: Vitreous -Retina- Macula Consultants of New York
Start date: 2010-05-01; Completion date: 2012-01-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to their treatment assignment.

The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.

Detailed description:

Arms: arm 1: Lucentis 2.0 mg arm 2: None
Interventions: intervention 1: Ranibizumab intervention 2: Ranibizumab
Intervention descriptions: intervention 1: 2.0 mg intervention 2: 0.5 mg

Protocol documents:
Clinical trial NCT01129531
Conditions: Neuralgia, Postherpetic
Sponsor: Allergan
Start date: 2010-06-01; Completion date: 2012-01-01
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.

Detailed description:

Arms: arm 1: AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment. arm 2: AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment. arm 3: Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Interventions: intervention 1: AGN-214868 intervention 2: Placebo to AGN-214868
Intervention descriptions: intervention 1: AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment. intervention 2: Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

Protocol documents:
Clinical trial NCT01130493
Conditions: Parkinson's Disease
Sponsor: Impax Laboratories, LLC
Start date: 2010-05-01; Completion date: 2012-01-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

Detailed description:
This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.

Arms: arm 1: Dose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2) arm 2: Dose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)
Interventions: intervention 1: IPX066 intervention 2: CLE
Intervention descriptions: intervention 1: experimental product intervention 2: active comparator

Protocol documents:
Clinical trial NCT01153347
Conditions: Major Depressive Disorder Depression
Keywords: Major Depressive Disorder MDD Depression Safety add-on therapy
Sponsor: AstraZeneca
Start date: 2010-06-01; Completion date: 2012-01-01
Enrollment: 2409 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Detailed description:

Arms: arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID arm 3: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID arm 4: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Interventions: intervention 1: TC-5214 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, oral, twice daily for 8 weeks intervention 2: Tablet, oral, twice daily for 8 weeks

Protocol documents:
Clinical trial NCT01157533
Conditions: Infection
Keywords: Vancomycin Pharmacokinetic testing PK
Sponsor: M.D. Anderson Cancer Center
Start date: 2010-06-01; Completion date: 2012-01-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if giving a larger than normal "loading dose" of the antibiotic vancomycin before starting standard vancomycin dosing can help patients reach and maintain the needed blood-level of the antibiotic during treatment.

Detailed description:
The Study Drug:

Vancomycin is an antibiotic used to treat serious, life-threatening infections caused by bacteria. Researchers want to find the best and most effective dose and blood-level of the drug that may have the best effect against bacteria.

Study Drug Administration:

If your doctor believes you are eligible, and you agree to take part in this study, you will be given a "loading dose" of vancomycin that is about twice as large as the standard dose. The dose amounts will be based on your body weight. Doses can be given every 8-12 hours, depending on your level of kidney function.

Study Procedures:

Blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing and to check your kidney function. PK testing measures the amount of study drug in the body at different time points. PK blood samples will be drawn just after the loading dose, and then just before each standard dose of vancomycin (up to 5 samples total). When possible, the PK sample may be drawn through a central venous catheter or line you already have placed, to avoid extra "needle sticks."

The study staff will collect information about your health and any side effects you may be having for 7 days.

Length of Study:

Treatment with vancomycin may be stopped early if you experience intolerable side effects or the doctor thinks you can stop taking the drug early.

This is an investigational study. Vancomycin is FDA approved and commercially available for use in treating bacterial infection. The use of a loading dose for vancomycin is investigational.

Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
Interventions: intervention 1: Vancomycin
Intervention descriptions: intervention 1: Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.

Protocol documents:
Clinical trial NCT01163266
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder Depression Melancholia Drug Therapy
Sponsor: Takeda
Start date: 2010-07-01; Completion date: 2012-01-01
Enrollment: 462 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.

Detailed description:
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.

The study enrolled 462 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 10 mg
* Vortioxetine 20 mg
* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 13 weeks. Participants made 9 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Arms: arm 1: Placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate release tablets intervention 2: Vortioxetine placebo-matching capsules

Protocol documents:
Clinical trial NCT01170247
Conditions: Sedation
Keywords: Procedural Sedation
Sponsor: University of Iowa
Start date: 2011-01-01; Completion date: 2012-01-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ketamine intervention 2: Ketamine
Intervention descriptions: intervention 1: Intranasal Ketamine (100 mg/mL) intervention 2: Intramuscular Ketamine

Protocol documents:
Clinical trial NCT01185080
Conditions: Allergic Rhinitis
Keywords: AZD8848 allergic rhinitis efficacy tolerability safety nasal symptoms
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2012-01-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to investigate effect, tolerability and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of season in an allergen challenge model.

Detailed description:
A double-blind, placebo controlled, randomised, parallel group phase IIa study to investigate the efficacy, tolerability, and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of pollen season in a nasal allergen challenge model

Arms: arm 1: 20 μg AZD8848 three times weekly arm 2: Placebo three times weekly arm 3: 60 μg AZD8848 once weekly and placebo twice weekly
Interventions: intervention 1: AZD8848 intervention 2: Placebo intervention 3: AZD8848 and placebo
Intervention descriptions: intervention 1: Nasal spray solution, intranasal, three times weekly for one month intervention 2: Nasal spray solution, intranasal, three times weekly for one month intervention 3: Nasal spray solution, intranasal, three times weekly for one month

Protocol documents:
Clinical trial NCT01189435
Conditions: Lung Cancer
Keywords: OSI-774, TARCEVA (ERLOTINIB) Lung recurrent 10-097 Gefitinib
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2010-08-01; Completion date: 2012-01-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.

Detailed description:

Arms: arm 1: This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.
Interventions: intervention 1: erlotinib
Intervention descriptions: intervention 1: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.

Protocol documents:
Clinical trial NCT01191944
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2012-01-01
Enrollment: 475 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .

Detailed description:

Arms: arm 1: subjects will receive 0.375mg once a day to 4.5mg once a day depending on investigator's judgement arm 2: subjects will receive 0.125mg three times a day to 1.0mg three times a day depending on investigator's judgement
Interventions: intervention 1: pramipexole immediate release tablet intervention 2: pramipexole extended release tablet
Intervention descriptions: intervention 1: 0.375mg-4.5mg(daily dose), three times a day intervention 2: 0.375mg-4.5mg, once a day

Protocol documents:
Clinical trial NCT01192191
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GW642444 COPD Fluticasone Furoate
Sponsor: GlaxoSmithKline
Start date: 2010-08-01; Completion date: 2012-01-01
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.

Detailed description:

Arms: arm 1: Combination inhaled corticosteroid and long-acting beta2-agonist arm 2: Combination inhaled corticosteroid and long-acting beta2-agonist
Interventions: intervention 1: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg intervention 2: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
Intervention descriptions: intervention 1: Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks intervention 2: Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

Protocol documents:
Clinical trial NCT01197508
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, MDD, Depression
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2012-01-01
Enrollment: 696 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Detailed description:
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Arms: arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID arm 3: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID arm 4: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Interventions: intervention 1: TC-5214 intervention 2: Placebo
Intervention descriptions: intervention 1: Twice daily for 8 weeks. intervention 2: Twice daily for 8 weeks.

Protocol documents:
Clinical trial NCT01198873
Conditions: Atrial Fibrillation
Sponsor: Sanofi
Start date: 2010-09-01; Completion date: 2012-01-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

\- Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the progression of adverse left atrial remodeling in patients with atrial fibrillation (AF) following 12 months of treatment.

Secondary Objectives:

* Evaluate the effects of dronedarone versus placebo on left atrial function;
* Evaluate the effects of dronedarone versus placebo on left atrial dimension;
* Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF, E, E', A, E/E')
* Evaluate the safety and tolerability of dronedarone.

Detailed description:
The planned total study period per participant was 12 months and 3 weeks broken down as follows:

* Screening period: up to 1 week;
* Treatment period: 12 months;
* Follow-up period: 2 weeks.

Arms: arm 1: Dronedarone 400 mg twice a day arm 2: Placebo (for Dronedarone) twice a day
Interventions: intervention 1: Dronedarone intervention 2: Placebo (for Dronedarone)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner) intervention 2: film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Protocol documents:
Clinical trial NCT01200602
Conditions: Anorexia Weight Changes
Sponsor: Mayo Clinic
Start date: 2011-03-01; Completion date: 2012-01-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.

Detailed description:
PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.

SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.

Arms: arm 1: Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. arm 2: Patients have clinical observation for weight loss and gain for 4 weeks.
Interventions: intervention 1: megestrol acetate intervention 2: clinical observation
Intervention descriptions: intervention 1: Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day intervention 2: No treatment is given.

Protocol documents:
Clinical trial NCT01204294
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-09-01; Completion date: 2012-01-01
Enrollment: 574 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.

Detailed description:

Arms: arm 1: biguanide plus linagliptin arm 2: glinide plus linagliptin arm 3: glitazone plus linagliptin arm 4: sulfonylurea plus linagliptin arm 5: alpha-glucosidase inhibitor plus linagliptin arm 6: sulfonylurea plus metformin arm 7: alpha-glucosidase inhibitor plus metformin
Interventions: intervention 1: Linagliptin intervention 2: Linagliptin intervention 3: Metformin intervention 4: Metformin intervention 5: Linagliptin intervention 6: Linagliptin intervention 7: Linagliptin
Intervention descriptions: intervention 1: Linagliptin once daily intervention 2: Linagliptin once daily intervention 3: Metformin twice or three time per day intervention 4: Metformin twice or three time per day intervention 5: Linagliptin once daily intervention 6: Linagliptin once daily intervention 7: Linagliptin once daily

Protocol documents:
Clinical trial NCT01230021
Conditions: Congenital Bleeding Disorder Congenital FXIII Deficiency
Sponsor: Novo Nordisk A/S
Start date: 2010-11-01; Completion date: 2012-01-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: catridecacog
Intervention descriptions: intervention 1: Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg bodyweight

Protocol documents: