ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01256879
Conditions: Healthy
Keywords: cimetidine pharmacokinetics formulation
Sponsor: University of Maryland, Baltimore
Start date: 2011-03-01; Completion date: 2014-05-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.

Detailed description:
The investigators anticipate that common excipients do not cause bioINequivalence. 1) The hypothesize is that commonly used excipients in oral medications change the rate or extent of Class 3 drug absorption and result in bioINequivalence. 2) Alternative hypothesis is that commonly used excipients in oral medications do not change the rate or extent of Class 3 drug absorption and do not result in bioINequivalence.

Arms: arm 1: 200mg cimetidine (as 2 capsules) arm 2: 200mg cimetidine (as 2 capsules) arm 3: 200mg cimetidine (as oral liquid) arm 4: 200mg cimetidine (as oral liquid)
Interventions: intervention 1: Drug: cimetidine
Intervention descriptions: intervention 1: cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution

Protocol documents:
Clinical trial NCT01264887
Conditions: Cancer Chronic Pain Pain
Keywords: analgesia analgesics chronic pain tumour related pain chronic malignant tumor-related pain
Sponsor: Grünenthal GmbH
Start date: 2011-03-01; Completion date: 2014-05-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is the characterization of the long term safety profile and long-term dose requirements of tapentadol PR (prolonged release) in patients with malignant tumor-related pain. In the United States the prolonged-release formulation is also referred to as the extended-release formulation.

Detailed description:
The prevalence of tumor-related pain is high and the treatment of chronic tumor-related pain remains a challenging therapeutic problem.

Participants directly entering the KF5503/52 trial from the KF5503/15 trial (i.e., within 7 days of Visit 8 of the KF5503/15 trial) is scheduled: a Transfer Visit, an Open-label Treatment Period and a Follow-up Period.

For participants with a gap of more than 7 days and less than 24 weeks, between their full completion of the KF5503/15 trial and entry into the KF5503/52 trial the following is scheduled: an Enrollment Visit, an Entry Visit for assessment of eligibility, an Open-label Treatment Period and a Follow-up Period.

This trial was designed to offer patients with chronic malignant tumor-related pain the option of continuing treatment by receiving tapentadol prolonged release (PR).

The protocol scheduled visits every 28 days during the open-label treatment period. Unscheduled visits (or at least unscheduled telephone calls) were planned when dose adjustment is required. If a visit is not possible at the time of dose change, it could be done up to 7 days later. Unscheduled visits could also be performed whenever considered necessary (i.e., for evaluation of adverse events).

Arms: arm 1: Participants allocated to this treatment arm can be flexibly dosed between 100 to 250 mg tapentadol twice daily (50 and 100 mg tablets to be dispensed).
Interventions: intervention 1: Tapentadol Prolonged Release
Intervention descriptions: intervention 1: Titration to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerates and wishes to continue treatment.

Protocol documents:
Clinical trial NCT01278615
Conditions: Recurrent Adult Diffuse Large Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-12-01; Completion date: 2014-05-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II clinical trial is studying how well selumetinib works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the overall response rate (combined complete remission \[CR\] and partial remission \[PR\]) of AZD6244 hyd-sulfate anti-MEK (selumetinib) therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of MEK inhibitor therapy. II. To determine the progression-free survival, time to treatment failure, duration of response, and overall survival with AZD6244 hyd-sulfate therapy.

III. To examine biomarkers through down-regulation of phosphorylated extracellular signal-related kinase (pERK) and several relevant target substrates (e.g., monocarboxylate transporter-1 \[MCT-1\], Menkes disease-associated protein \[MNK\], ELK, c-v-myc avian myelocytomatosis viral oncogene homolog \[c-MYC\], and hypoxia-inducible factor-1alpha \[HIF-1a\]) in peripheral blood studies.

OUTLINE: This is a multicenter study.

Patients receive selumetinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample and tumor tissue collection at baseline and at day 15 of course 1 for biomarker studies.

After completion of study therapy, patients are followed up every 3 months for up to 3 years.

Arms: arm 1: Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Selumetinib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO

Protocol documents:
Clinical trial NCT01280123
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease Biomarkers
Sponsor: University of Rochester
Start date: 2011-03-01; Completion date: 2014-05-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility.

Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no more than 8 months, will be randomized to one of two dosages of oral pioglitazone (15 mg and 45 mg) or matching placebo.

The study will measure disease progression by the change in total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline visit and 44 weeks.

Detailed description:
A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's Disease (PD). The patient population has early stage PD (\< 5 years from diagnosis), must be treated with 1 mg/day of rasagiline or 10 mg/day of selegiline for at least 8 weeks but not more than 8 months prior to enrollment.

The primary objective of this clinical trial is to assess the futility of pioglitazone on PD disease progression as measured by the change in total UPDRS score between the baseline visit and 44 weeks. The secondary objectives of the study are to collect additional efficacy and safety/tolerability data to be used in planning a subsequent Phase III trial of pioglitazone in early, treated PD. Measures of cognition, mood and blood- and urine-based biomarkers will also be explored. Subjects in this trial are randomly assigned in a 1:1:1 ratio to one of three study arms: 15 mg, 45 mg or placebo.

Arms: arm 1: 15 mg pioglitazone arm 2: 45 mg pioglitazone arm 3: Placebo
Interventions: intervention 1: Pioglitazone intervention 2: placebo
Intervention descriptions: intervention 1: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd

Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. intervention 2: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule.

Protocol documents:
Clinical trial NCT01286259
Conditions: HIV-1 Infection
Keywords: HIV HAART suppressed Disulfiram Antabuse Latent reservoir Eradication Cure
Sponsor: University of California, San Francisco
Start date: 2011-01-01; Completion date: 2014-05-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether a two-week course of disulfiram will reduce the HIV-1 latent reservoir in patients on highly active antiretroviral therapy (HAART).

Detailed description:
This study is using a new approach to try and force HIV out of its protected cellular reservoirs.

Although current therapies are effective at "killing" new viruses that are produced, they are unable to access the virus in cells which were infected before antiretroviral therapy began. HIV can remain "hidden" in a latent (or resting) form in these cells for many years. Since these infected cells can live for many years, they are thought to be the most important barrier to HIV eradication (or "cure").

Many experts believe that one way to attack latent or "hidden" HIV is to use a drug than can "turn on" the virus and hence force HIV-1 out of resting T cells. In a recent study done in the laboratory, disulfiram proved to be among the most effective drugs currently available that can reactivate latent HIV-1,

Our primary hypothesis is that disulfiram will reduce the latent reservoir of HIV-1 in patients on highly active antiretroviral therapy (HAART). Theoretically, disulfiram will force HIV to replicate (grow) and thus result in the death of the infected cell. Standard antiretroviral drugs should prevent new cells from becoming infected. The end result of this process is that the total amount of HIV in the body will decline over time.

Arms: arm 1: None
Interventions: intervention 1: Disulfiram
Intervention descriptions: intervention 1: Open label 500mg disulfiram per day by mouth for 14 days

Protocol documents:
Clinical trial NCT01315145
Conditions: Lumbar Spinal Stenosis
Sponsor: Vertos Medical, Inc.
Start date: 2011-03-01; Completion date: 2014-05-01
Enrollment: 138 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.

Detailed description:
The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.

Arms: arm 1: Patients receiving percutaneous decompression using the mild® Device Kit. arm 2: Injection of epidural steroids into the lumbar spine
Interventions: intervention 1: Percutaneous Lumbar Decompression intervention 2: Epidural Steroid Injection
Intervention descriptions: intervention 1: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue. intervention 2: Injection of epidural steroids into the lumbar spine

Protocol documents:
Clinical trial NCT01327677
Conditions: Pain
Keywords: pain management opioid analgesic therapy safety craniotomy
Sponsor: Johns Hopkins University
Start date: 2011-05-01; Completion date: 2014-05-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

Detailed description:
See brief summary

Arms: arm 1: A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain. arm 2: Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.
Interventions: intervention 1: Fentanyl intervention 2: Fentanyl
Intervention descriptions: intervention 1: 25-50 mcg every 20 minutes intervention 2: 20mcg/demand dose with an 8 minute lock out

Protocol documents:
Clinical trial NCT01356966
Conditions: Kidney Failure, Chronic
Sponsor: Emory University
Start date: 2011-05-01; Completion date: 2014-05-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with chronic kidney disease have profound exercise intolerance which contributes to an increased risk of cardiovascular disease. The investigators have found that chronic kidney disease patients have an exaggerated increase in blood pressure during certain forms of exercise that could certainly contribute to exercise dysfunction as well as cardiovascular risk. The investigators will test the mechanisms underlying this exaggerated blood pressure response, as well as the potential benefits of short-term tetrahydrobiopterin (BH4) with folic acid on both exercise dysfunction and cardiovascular risk factors in chronic kidney disease. The investigators will test whether short-term treatment with tetrahydrobiopterin (BH4), a cofactor for nitric oxide, together with folic acid improves inflammation, vascular health, and adrenaline levels, both at rest and during exercise in chronic kidney disease.

Detailed description:

Arms: arm 1: Male subjects with hypertension and chronic kidney disease stage 2 or 3 will receive Tetrahydrobiopterin (6R-BH4) 200 mg twice daily and folic acid 1 mg daily arm 2: Male subjects with hypertension and chronic kidney disease stage 2 or 3 will receive 2 placebo pills twice daily and folic acid 1 mg daily
Interventions: intervention 1: Tetrahydrobiopterin intervention 2: Placebo intervention 3: Folate
Intervention descriptions: intervention 1: Tetrahydrobiopterin (BH4) 200 mg PO BID for 12 weeks intervention 2: 2 placebo pills PO BID for12 weeks intervention 3: Folate 1 mg daily for 12 weeks

Protocol documents:
Clinical trial NCT01358864
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2011-06-01; Completion date: 2014-05-01
Enrollment: 678 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

Detailed description:

Arms: arm 1: patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks arm 2: patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks arm 3: patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Interventions: intervention 1: BI 201335 intervention 2: Pegylated Interferon-alpha (IFN) intervention 3: Ribavirin (RBV) intervention 4: Placebo
Intervention descriptions: intervention 1: BI 201335 once a day (QD) for 24 weeks intervention 2: Pegylated Interferon-alpha for 48 weeks intervention 3: Ribavirin (RBV) for 24 or 48 weeks intervention 4: Placebo to BI201335 for 24 weeks

Protocol documents:
Clinical trial NCT01369615
Conditions: Pain
Keywords: Malignant pain Nonmalignant pain Pain Pediatric Opioid Moderate to severe
Sponsor: Purdue Pharma LP
Start date: 2011-10-01; Completion date: 2014-05-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.

Detailed description:

Arms: arm 1: Oxycodone hydrochloride controlled-release tablets
Interventions: intervention 1: Oxycodone hydrochloride controlled-release tablets
Intervention descriptions: intervention 1: Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.

Protocol documents:
Clinical trial NCT01371851
Conditions: Methamphetamine or Cocaine Dependence
Sponsor: University of Arkansas
Start date: 2011-06-01; Completion date: 2014-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Psychostimulant dependence is a major public health problem and no medications have been shown to be very effective in treating this disorder. Thus, the investigators wish to study whether a blood pressure drug thought to reduce drug craving through its interaction at particular adrenergic receptors - doxazosin - can dredge cocaine use relative to placebo in psychostimulant dependent participants enrolled in an 8-week, randomized, double blind, placebo-controlled outpatient clinical trial. Our hypothesis is that doxazosin will reduce cocaine use relative to placebo in psychostimulant dependent participants.

Detailed description:

Arms: arm 1: Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial. arm 2: Participants will be maintained on placebo (cellulose) throughout the trial.
Interventions: intervention 1: Doxazosin extended release
Intervention descriptions: intervention 1: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.

Protocol documents:
Clinical trial NCT01396395
Conditions: Stable Angina Coronary Disease
Keywords: Nicorandil Stable angina
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2011-09-01; Completion date: 2014-05-01
Enrollment: 402 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of the standard treatment for 12 weeks, while the control group will stay on standard treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not affect the primary endpoint may be adjusted per investigators decision.

Detailed description:

Arms: arm 1: The subjects will receive nicorandil 5 milligram (mg ) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (such as aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \[(ACEIs\] as permitted by disease condition /as per standard local practices/prescribed per discretion of investigators). arm 2: None
Interventions: intervention 1: Nicorandil intervention 2: Standard Treatment
Intervention descriptions: intervention 1: The subjects will receive Nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with the standard treatment. intervention 2: The subjects will receive one of the standard anti-anginal therapies which included but not limited to aspirin, ACEI, lipid lowering statins and beta blockers according to the recommendation of guidelines. If the subject's condition permitted, they should take all these medicines. However, the dose, route, frequency and duration were determined by investigators according to subject's specific condition.

Protocol documents:
Clinical trial NCT01399697
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-09-01; Completion date: 2014-05-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: methotrexate intervention 2: methotrexate intervention 3: placebo intervention 4: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: orally, Week 1 - 16 intervention 2: orally, Week 17-28 intervention 3: methotrexate placebo orally, Week 17-28 intervention 4: 8 mg/kg iv every 4 weeks, 28 weeks

Protocol documents: