ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01641237
Conditions: Enamel Erosion
Sponsor: GlaxoSmithKline
Start date: 2012-03-01; Completion date: 2012-05-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.

Detailed description:

Arms: arm 1: Low ppm fluoride as sodium fluoride in a silica base dentifrice arm 2: Medium ppm fluoride as sodium fluoride in a silica base dentifrice arm 3: High ppm fluoride as sodium fluoride in a silica base dentifrice arm 4: no added fluoride in a silica base dentifrice
Interventions: intervention 1: sodium fluoride intervention 2: no added fluoride in a silica base
Intervention descriptions: intervention 1: fluoride as sodium fluoride intervention 2: no added fluoride

Protocol documents:
Clinical trial NCT00838201
Conditions: Cancer Carcinoma Castrate-Resistant Prostate Cancer Prostate Cancer Tumors
Keywords: Androgen deprivation therapy for non-metastatic prostate cancer
Sponsor: Amgen
Start date: 2009-02-01; Completion date: 2012-05-03
Enrollment: 384 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Denosumab
Intervention descriptions: intervention 1: 60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

Protocol documents:
Clinical trial NCT01180634
Conditions: Cystic Fibrosis
Sponsor: Amgen
Start date: 2010-11-04; Completion date: 2012-05-07
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.

Detailed description:
This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Participants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days. arm 2: Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.
Interventions: intervention 1: Aeroquin intervention 2: Placebo
Intervention descriptions: intervention 1: Inhalation Solution intervention 2: Inhalation Solution

Protocol documents:
Clinical trial NCT01375764
Conditions: Hyperlipidemia
Keywords: Proprotein convertase subtilisin/kexin type 9 (PCSK9) Cholesterol High Cholesterol Raised Cholesterol Elevated Cholesterol Statin intolerant Hypercholesterolemia
Sponsor: Amgen
Start date: 2011-07-28; Completion date: 2012-05-08
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. arm 2: Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. arm 3: Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. arm 4: Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. arm 5: Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Interventions: intervention 1: Evolocumab intervention 2: Ezetimibe intervention 3: Placebo to Evolocumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered orally once a day intervention 3: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT00810693
Conditions: Pulmonary Hypertension
Keywords: Pulmonary arterial hypertension PH Stimulator
Sponsor: Bayer
Start date: 2008-12-17; Completion date: 2012-05-14
Enrollment: 445 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

Detailed description:

Arms: arm 1: Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks arm 2: Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks arm 3: Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Riociguat (Adempas, BAY63-2521) intervention 3: Placebo
Intervention descriptions: intervention 1: BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks intervention 2: BAY63-2521: 1.5mg tid orally for 12 weeks intervention 3: Matching Placebo tid orally for 12 weeks

Protocol documents:
Clinical trial NCT01385033
Conditions: Alzheimer's Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-08-19; Completion date: 2012-05-15
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate radiolabeled \[18F\]MK-3328 as a PET tracer for estimating the regional distribution and extent of amyloid plaques in participants suffering from amnestic mild cognitive impairment (aMCI) and Alzheimer's Disease (AD) versus healthy young and elderly participants. The study hypotheses will test whether \[18F\]MK-3328 can discriminate between AD participants and cognitively normal elderly control participants as measured by brain regional tracer uptake.

Detailed description:

Arms: arm 1: HE and AD participants will receive a single intravenous (IV) dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part I of the study arm 2: Healthy Young, HE and AD participants will receive a single IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part II of the study arm 3: Participants with aMCI will receive a single IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part III of the study
Interventions: intervention 1: [18F]MK-3328
Intervention descriptions: intervention 1: IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328

Protocol documents:
Clinical trial NCT01000610
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2008-03-17; Completion date: 2012-05-16
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is \<50

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: methotrexate intervention 3: methylprednisolone
Intervention descriptions: intervention 1: 1000 mg iv infusion on days 1 and 15 intervention 2: 10-25 mg weekly (oral or parenteral) intervention 3: 100 mg iv prior to each rituximab infusion

Protocol documents:
Clinical trial NCT00848718
Conditions: Locally Advanced, Metastatic Solid Tumors
Keywords: Tumors, cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-03-17; Completion date: 2012-05-17
Enrollment: 77 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors.

The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations.

Detailed description:

Arms: arm 1: MK-2206 combined with carboplatin and paclitaxel arm 2: MK-2206 combined with docetaxel plus pretreatment with a corticosteroid arm 3: MK-2206 combined with erlotinib
Interventions: intervention 1: MK-2206 intervention 2: docetaxel intervention 3: erlotinib intervention 4: carboplatin intervention 5: paclitaxel intervention 6: corticosteroid
Intervention descriptions: intervention 1: MK-2206 given by mouth (PO) on Days 1, 3, 5, and 7 of each 21-day cycle (30 mg, 45 mg, or 60 mg) OR MK-2206 PO on Day 1 of each 21-day cycle (60 mg, 90 mg, 135 mg, 200 mg , or 250 mg) intervention 2: Administered as an IV infusion on Day 1 of each 21-day cycle intervention 3: Administered daily (QD) PO in each 21-day cycle intervention 4: Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle intervention 5: Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle intervention 6: Administered PO twice a day (BID) on Days 1-3 of each 21-day cycle

Protocol documents:
Clinical trial NCT01391273
Conditions: Eyelash Hypotrichosis
Sponsor: Allergan
Start date: 2011-07-01; Completion date: 2012-05-19
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.

Detailed description:

Arms: arm 1: One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. arm 2: One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Interventions: intervention 1: bimatoprost solution 0.03% intervention 2: bimatoprost vehicle solution
Intervention descriptions: intervention 1: One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. intervention 2: One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

Protocol documents:
Clinical trial NCT01414114
Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2 Renal Dialysis Secondary Hyperparathyroidism Chronic kidney disease-mineral and bone disorder Parathyroid hormone
Sponsor: KAI Pharmaceuticals
Start date: 2011-12-05; Completion date: 2012-05-21
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).

Detailed description:

Arms: arm 1: Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
Interventions: intervention 1: Etelcalcetide
Intervention descriptions: intervention 1: Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.

Protocol documents:
Clinical trial NCT00980174
Conditions: Low Bone Mass Low Bone Mineral Density Males With Osteoporosis Osteopenia Osteoporosis
Keywords: men male denosumab BMD lumbar spine ADAMO The ADAMO Trial male osteoporosis osteoporosis in men males with low bone mineral density
Sponsor: Amgen
Start date: 2009-10-01; Completion date: 2012-05-23
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture. The primary clinical hypothesis is that in men with low bone mineral density, the mean percent change in lumbar spine bone mineral density at 12 months in subjects receiving denosumab will be greater than in subjects receiving placebo. Denosumab is a fully human monoclonal antibody with a high affinity for Receptor Activator of Nuclear Factor (RANK) Ligand that can bind and neutralize the activity of human RANK Ligand similar to the action of endogenous osteoprotegerin.

Detailed description:

Arms: arm 1: Subjects will receive placebo for denosumab (SC injection every 6 months) for 1 year (double-blind phase) followed by 60 mg denosumab (SC injection every 6 months) for 1 year (open-label phase) arm 2: 60 mg denosumab (SC injection every 6 months) for 1 year (double-blind phase) followed by 60 mg denosumab(SC injection every 6 months) for 1 year (open-label phase). These subjects will be on denosumab for a total of 2 years.
Interventions: intervention 1: 60 mg denosumab intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg denosumab (SC injection every 6 months) intervention 2: Placebo for denosumab (SC injection every 6 months)

Protocol documents:
Clinical trial NCT00964782
Conditions: Fontan Circulation
Keywords: Fontan sildenafil exercise capacity Patients with Fontan Circulation
Sponsor: Milton S. Hershey Medical Center
Start date: 2009-08-01; Completion date: 2012-05-24
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.

Detailed description:

Arms: arm 1: Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2, placebo drug administered before the exercises. arm 2: Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2 Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
Interventions: intervention 1: Sildenafil intervention 2: Placebo intervention 3: Sildenafil 2 intervention 4: Placebo 2
Intervention descriptions: intervention 1: oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo. intervention 2: Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil. intervention 3: oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo). intervention 4: Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).

Protocol documents:
Clinical trial NCT01391286
Conditions: Eyelash Hypotrichosis
Sponsor: Allergan
Start date: 2011-07-01; Completion date: 2012-05-25
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.

Detailed description:

Arms: arm 1: One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. arm 2: One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Interventions: intervention 1: bimatoprost solution 0.03% intervention 2: bimatoprost vehicle solution
Intervention descriptions: intervention 1: One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. intervention 2: One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

Protocol documents:
Clinical trial NCT01370863
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD Gastroesophageal reflux disease SPD557 Proton pump inhibitors
Sponsor: Shire
Start date: 2010-12-02; Completion date: 2012-05-29
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD557 intervention 2: placebo
Intervention descriptions: intervention 1: 0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment intervention 2: matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment

Protocol documents:
Clinical trial NCT00090051
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Hoffmann-La Roche
Start date: 2003-07-31; Completion date: 2012-05-31
Enrollment: 552 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rituximab intervention 2: Fludarabine Phosphate intervention 3: Cyclophosphamide
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Intravenous repeating dose

Protocol documents:
Clinical trial NCT01164007
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2006-06-30; Completion date: 2012-05-31
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the preliminary anti-tumor activity and safety profile of a combination of bevacizumab and dacarbazine in participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease.

Detailed description:

Arms: arm 1: Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease will receive dacarbazine and bevacizumab until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
Interventions: intervention 1: Bevacizumab intervention 2: Dacarbazine
Intervention descriptions: intervention 1: Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Days 1 and 14 of each 28-day cycle. intervention 2: Dacarbazine will be given as 800 milligrams per square meter (mg/m\^2) via IV infusion on Day 1 of each 28-day cycle.

Protocol documents: