ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01089569
Conditions: Type 2 Diabetes
Keywords: diabetes continuous glucose monitoring exenatide insulin glargine
Sponsor: HealthPartners Institute
Start date: 2010-04-01; Completion date: 2013-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

Detailed description:
The primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management.

An ancillary study was approved as part of this study. The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.

Arms: arm 1: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study arm 2: .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results arm 3: Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Interventions: intervention 1: Exenatide intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study intervention 2: .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Protocol documents:
Clinical trial NCT01091675
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis biologic therapies ASAS ASASBIO etoricoxib NSAIDs COX-2 Inhibitor ARCOXIA 90 mg BASDAI Bath Ankylosing Spondylitis Disease Activity Index
Sponsor: Spanish Foundation of Rheumatology
Start date: 2010-09-01; Completion date: 2013-05-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this research is to assess the percentage of non-responders to ≥ 2 NSAIDs candidates a biological therapy that could adequately respond to treatment with etoricoxib This study confirm the result of a previous study in a wider similar population. Basing on previous results, the response rate will be assessed by ASASBIO criteria. The efficacy of the treatment with etoricoxib 90 mg will be assessed at week 4 in a population of patients with AS who didn't respond adequately to a previous therapy with ≥ 2 NSAIDs.

Those patients that, based on the ASABIO criteria, achieved a sufficient clinical response will be followed until week 24 to asses the maintenance of the study drug effects.

Detailed description:
Etoricoxib is an oral, selective cyclooxygenase 2 inhibitor approved for the symptomatic treatment of ankylosing spondylitis (AS) in Spain.

Etoricoxib is a marketed product indicated for the relief of symptomatic osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, pain and signs of inflammation associated with acute gouty arthritis. In ankylosing spondylitis,the recommended dose is 90 mg once daily.

Clinical pharmacology studies demonstrate that Etoricoxib induce dose-dependent inhibition of COX-2 without inhibit COX-1, up to 150 mg daily dose.

Etoricoxib did not inhibit the gastric synthesis of prostaglandin and had no effect on platelet function. Cyclooxygenase is responsible for the prostaglandin synthesis. Were identified two different isoforms of cyclooxygenase, COX-1 and COX-2. It has been shown that COX-2 is the major enzyme responsible for the synthesis of prostanoid mediators involved in pain, inflammation and fever.

Arms: arm 1: All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.
Interventions: intervention 1: Etoricoxib
Intervention descriptions: intervention 1: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.

Protocol documents:
Clinical trial NCT01118663
Conditions: Acetaminophen Overdose
Keywords: Acetaminophen overdose; induced hepatotoxicity, liver injury
Sponsor: Cumberland Pharmaceuticals
Start date: 2010-09-01; Completion date: 2013-05-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.

Detailed description:
The primary objective of this study is to demonstrate non-inferiority of efficacy determined by the proportion of subjects who develop hepatotoxicity when treated with a new formulation of Acetadote and the proposed new dosing regimen compared to the rate of hepatotoxicity with the current formulation of Acetadote and the current dosing regimen.

Arms: arm 1: Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\] arm 2: Acetadote \[Old formulation containing EDTA\]
Interventions: intervention 1: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) intervention 2: Acetadote
Intervention descriptions: intervention 1: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours intervention 2: Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.

Protocol documents:
Clinical trial NCT01137578
Conditions: Thrombosis
Sponsor: Bristol-Myers Squibb
Start date: 2011-02-01; Completion date: 2013-05-01
Enrollment: 151 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This protocol will serve as a pilot study to determine the validity and feasibility of contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or ultrasound (US) for detection of catheter related deep vein thrombosis (DVT) in children

Detailed description:

Arms: arm 1: Subjects with a central venous catheter (CVC) in place and asymptomatic for a CVC-related DVT to have an Ultrasound (US), Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed. arm 2: Subjects with a CVC in place either symptomatic for a CVC-related DVT or having an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons to have an Ultrasound, Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed. arm 3: Subjects with a CVC in place having an MRI for clinical reasons to have an Ultrasound, Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed.
Interventions: intervention 1: Ultrasound intervention 2: Magnetic Resonance Imaging with Contrast intervention 3: Magnetic Resonance Imaging without Contrast
Intervention descriptions: intervention 1: Ultrasounds to be performed on children with central venous catheters intervention 2: Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters intervention 3: Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Protocol documents:
Clinical trial NCT01153581
Conditions: Orthostatic Intolerance
Sponsor: Yale University
Start date: 2006-02-01; Completion date: 2013-05-01
Enrollment: 109 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine the causes of "orthostatic intolerance" which occurs more commonly in women than in men. Orthostatic tolerance is the ability to remain standing up right for long periods of time, or to avoid dizziness when moving to standing from a seated or lying position.

Detailed description:
In this study we are interested in determining the impact of female reproductive hormones (estrogen and progesterone) on orthostatic tolerance (described above) so we administer these hormones to participants. We also test participants' orthostatic tolerance in our laboratory and use this information to place subjects into groups.

Arms: arm 1: Subjects were given 250 μg in 0.5ml normal saline for 16 days. (Organon, Roseland, NJ, USA) arm 2: The same women added 17β-Oestradiol, E2; 0.2 mg day-1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16. arm 3: The same women added progesterone (P4, 200 mg day-1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13-16.
Interventions: intervention 1: Ganirelix acetate intervention 2: 17β-Oestradiol intervention 3: Progesterone
Intervention descriptions: intervention 1: Ganirelix acetate: .25 ml/day by subcutaneous injection intervention 2: 17 beta estradiol: 0.2 mg/day (patches) intervention 3: progesterone, 200 mg day-1 oral

Protocol documents:
Clinical trial NCT01154335
Conditions: Metastatic Colorectal Cancer
Keywords: refractory metastatic colorectal cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-07-01; Completion date: 2013-05-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) of the combination of OSI-906 and everolimus for the treatment of patients with refractory metastatic colorectal cancer.

Detailed description:

Arms: arm 1: combination of OSI-906 and everolimus

OSI-906: 50 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days arm 2: combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 10mg Daily, cycle-28 days arm 3: combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days
Interventions: intervention 1: OSI-906 intervention 2: Everolimus
Intervention descriptions: intervention 1: Dose Level 1: 50 mg Twice a Day, cycle-28 days Dose Level 2: 100 mg Twice a Day, cycle-28 days Dose Level 2a: 100 mg Twice a Day, cycle-28 days intervention 2: Dose Level 1: 5mg Daily, cycle-28 days Dose Level 2: 10mg Daily, cycle-28 days Dose Level 2a: 5mg Daily, cycle-28 days

Protocol documents:
Clinical trial NCT01162135
Conditions: Prostate Cancer
Keywords: Digoxin Recurrent Prostate Cancer Prostate Specific Antigen
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2010-09-01; Completion date: 2013-05-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effectiveness of dioxin on prohibiting prostate cancer progression as measured by PSADT (prostate-specific antigen doubling time).

Detailed description:
This is a pilot phase II, open labeled single center study to assess the efficacy of digoxin on inhibiting PCa progression as measured by PSADT. The participants will take study drug digoxin, which is approved by FDA for the treatment of CHF, 125 or 250 mcg orally daily, titrated to the level of 0.8 - 2 ng/ml for total of 6 cycles (4 weeks/cycle). The lower dose of digoxin (such as 125 mcg/day) will be chosen if serum level reaches 0.8 ng/ml already. Patients may continue another 6 cycles if evident of clinical benefit.

Arms: arm 1: None
Interventions: intervention 1: Digoxin
Intervention descriptions: intervention 1: The participants will take study drug digoxin, which is approved by FDA for the treatment of CHF, 125 or 250 mcg orally daily, titrated to the level of 0.8 - 2 ng/ml for total of 6 cycles (4 weeks/cycle). The lower dose of digoxin (such as 125 mcg/day) will be chosen if serum level reaches 0.8 ng/ml already. Patients may continue another 6 cycles if evident of clinical benefit.

It is possible that some patients may need to receive 500 mcg per day to reach this targeted drug level. No further titration will be allowed beyond this FDA approved digoxin dose.

Protocol documents:
Clinical trial NCT01166997
Conditions: Submassive Pulmonary Embolism
Keywords: Pulmonary embolism Pulmonary thromboembolism anticoagulation thrombolysis ultrasound accelerated thrombolysis
Sponsor: Boston Scientific Corporation
Start date: 2010-07-01; Completion date: 2013-05-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (RV/LV ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA) as compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV ratio will be significantly reduced in the treatment arm compared to the control arm.

Detailed description:

Arms: arm 1: Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus. arm 2: Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.
Interventions: intervention 1: EkoSonic Endovascular System intervention 2: Unfractionated heparin
Intervention descriptions: intervention 1: The EkoSonic Endovascular System will be used to deliver \< 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus. intervention 2: Intravenous unfractionated heparin used for anticoagulation treatment

Protocol documents:
Clinical trial NCT01179334
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension Riociguat Blood Pressure
Sponsor: Bayer
Start date: 2010-08-01; Completion date: 2013-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pulmonary Arterial Hypertension (PAH) is a severe progressive disease with a high mortality. Although several drugs are available for the treatment of PAH none offer a cure, therefore there is still a high medical need for new treatments.

Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling vascular tone, which is impaired in patients with PAH. This causes constriction and thickening of the blood vessels wall in the lungs and increase of blood pressure in the lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness of breath on exertion, collapse and often the inability of the patient to perform their daily life activities.

Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat may be a new approach for the treatment of PAH.

The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH. The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate the effect of Riociguat on blood pressure in patients with PAH when given in combination with Sildenafil.

Detailed description:
Main objective: Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters in patients with symptomatic PAH Secondary objectives:To investigate the safety of the riociguat/sildenafil combination and changes in 6-minute walk test, World Health Organization (WHO) functional class, N terminal pro-brain natriuretic peptide, and variables obtained during right-heart catheterization after 12 weeks of treatment; pharmacokinetics of riociguat and sildenafil.

The study consists of one part. In study Part 1 only subjects (18) on stable sildenafil treatment of 20 mg tid have been enrolled. Study Part 2 will not start.

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. Participants continued to take daily stable sildenafil background treatment according to their prescriptions. arm 2: Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Placebo intervention 3: Sildenafil
Intervention descriptions: intervention 1: BAY63-2521: 1 mg tid - 2,5 mg tid oral for 12 weeks. intervention 2: Placebo for 12 weeks intervention 3: Participants continued to take daily stable sildenafil background treatment according to their prescriptions.

Protocol documents:
Clinical trial NCT01183169
Conditions: Hepatitis C
Keywords: Chronic hepatitis C Cyclophilin inhibitor
Sponsor: Debiopharm International SA
Start date: 2010-08-01; Completion date: 2013-05-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

Detailed description:

Arms: arm 1: Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks arm 2: Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks arm 3: ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV. arm 4: ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV. arm 5: Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
Interventions: intervention 1: Alisporivir intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin intervention 4: Placebo
Intervention descriptions: intervention 1: ALV 200 mg soft gel capsules administered orally intervention 2: PEG 180 μg administered via subcutaneous (s.c.) injection once weekly intervention 3: RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose intervention 4: ALV placebo soft gel capsules administered orally

Protocol documents:
Clinical trial NCT01188967
Conditions: Nicotine Dependence
Keywords: Drugs, Investigational Nicotine Dependence Therapies for Relapse to Nicotine Relapse Prevention Smoking Cessation Nicotine Cessation Therapies
Sponsor: Massachusetts General Hospital
Start date: 2010-08-01; Completion date: 2013-05-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to find out if an investigational drug, GSK598809 can help people who have very recently quit smoking; the investigators want to find out if continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To relapse means you "fall back" into smoking again after quitting. The investigators also want to find out if GSK598809 is safe to take without causing too many side effects.

Detailed description:
We propose to conduct a first test of the effect of the dopamine D3 receptor antagonist, GSK598809, on smoking behavior when treatment is started immediately following the quit date. To do this, we propose to conduct a 10-week, double-blind, placebo-controlled, proof of mechanism study in 90 adult smokers. Participants will complete baseline evaluations. They will receive manualized cognitive behavioral therapy, beginning prior to the quit date, and will set a quit date for the day before their week 2 study visit. They will be given short acting NRT (gum or lozenge) to use on their quit date. They will be asked to arrive for the week 2 visit with 18-24 hours abstinence and an expired air CO ≤ 10ppm. Those who do so will be randomly assigned to receive double blind GSK598809 or identical placebo for six weeks. Participants will begin double blind GSK598809 or placebo, both in conjunction with prn NRT up to 8 mg per day for two weeks. Participants will then continue double blind GSK598809 or placebo in the absence of NRT for 4 more weeks. At the end of this period (week 8 of the study), participants will then be followed 2 weeks after discontinuation of double blind treatment to complete the 10 weeks of the study.

Arms: arm 1: Active medication arm 2: Placebo
Interventions: intervention 1: GSK598809 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dose of 60 mg/day for a treatment period six weeks intervention 2: Placebo

Protocol documents:
Clinical trial NCT01201915
Conditions: Basal Cell Carcinoma
Sponsor: Genentech, Inc.
Start date: 2010-10-01; Completion date: 2013-05-01
Enrollment: 74 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent) operable basal cell carcinoma of the nodular subtype.

Detailed description:
For Cohort 1, the response to treatment was determined at the end of the 12 weeks of treatment. For Cohort 2, the response to treatment was determined after 12 weeks of treatment and 24 weeks of observation. For Cohort 3, the response to treatment was determined after intermittent dosing over a 20-week period, consisting of an initial 8-week treatment period, followed by a 4-week drug holiday period, followed by a second 8-week treatment period.

Arms: arm 1: Participants received vismodegib 150 mg orally daily for 12 weeks. arm 2: Participants received vismodegib 150 mg orally daily for 12 weeks. arm 3: Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
Interventions: intervention 1: Vismodegib
Intervention descriptions: intervention 1: Vismodegib was supplied in gelatin capsules.

Protocol documents: