ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01239355
Conditions: Adult Hepatocellular Carcinoma Advanced Adult Hepatocellular Carcinoma Localized Non-Resectable Adult Liver Carcinoma Recurrent Adult Liver Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-12-01; Completion date: 2013-02-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well MK2206 works in treating patients with advanced liver cancer that did not respond to previous therapy. MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate the median progression-free survival in patients with advanced hepatocellular carcinoma treated with MK-2206 after failure of one prior line of anti-angiogenic therapy.

SECONDARY OBJECTIVES:

I. Evaluate the objective response rate (CR + PR). II. Evaluate the median overall survival. III. Evaluate the tolerability and toxicity profile of MK-2206 in this patient population.

IV. Explore, in a preliminary fashion, potential molecular predictors of efficacy.

OUTLINE:

Patients receive oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3-6 months thereafter.

Arms: arm 1: Patients receive oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206 intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01254331
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-02-01; Completion date: 2013-02-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra]
Intervention descriptions: intervention 1: tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions

Protocol documents:
Clinical trial NCT01256567
Conditions: Breast Cancer Metastatic Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2013-02-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to investigate the safety and tolerability of the anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in Japanese participants with metastatic, or locally advanced breast cancer, with the aim of confirming the recommended dose of ramucirumab drug product (DP) in combination with docetaxel.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ramucirumab intervention 2: Docetaxel
Intervention descriptions: intervention 1: Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks. intervention 2: Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m\^2) every 3 weeks.

Protocol documents:
Clinical trial NCT01292447
Conditions: Pain
Keywords: Pain measurement Intrauterine devices Lidocaine
Sponsor: Women and Infants Hospital of Rhode Island
Start date: 2011-02-01; Completion date: 2013-02-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.

Detailed description:

Arms: arm 1: Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. arm 2: Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
Interventions: intervention 1: 2% lidocaine gel intervention 2: Placebo gel
Intervention descriptions: intervention 1: 120mg lidocaine x 1 intervention 2: Inert gel x 1

Protocol documents:
Clinical trial NCT01314261
Conditions: Chronic Hepatitis C Hepatitis C Virus (HCV) Infection
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-03-01; Completion date: 2013-02-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.

Detailed description:
The study was a randomized, double blind, placebo controlled study consisting of 2 substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo + pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks. Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and safety.

Arms: arm 1: Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. arm 2: Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. arm 3: Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. arm 4: Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Interventions: intervention 1: ABT-267 intervention 2: Pegylated interferon (pegIFN) intervention 3: Ribavirin (RBV) intervention 4: Placebo for ABT-267
Intervention descriptions: intervention 1: 5 mg or 25 mg tablets intervention 2: Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly intervention 3: 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day intervention 4: Participants received matching placebo tablet at each dose level for ABT-267.

Protocol documents:
Clinical trial NCT01338818
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: Attention Deficit /Hyperactivity Disorder, hyperactivity
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-01; Completion date: 2013-02-01
Enrollment: 299 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder

Detailed description:

Arms: arm 1: All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
Interventions: intervention 1: Ritalin LA (methylphenidate hydrochloride extended release)
Intervention descriptions: intervention 1: Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.

Protocol documents:
Clinical trial NCT01342770
Conditions: Stage IA Non-Small Cell Lung Carcinoma Stage IB Non-Small Cell Lung Carcinoma Stage IIA Non-Small Cell Lung Carcinoma Stage IIB Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2011-04-01; Completion date: 2013-02-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot phase II trial studies how well pioglitazone works in treating patients with stage IA-IIIA non-small cell lung cancer. Pioglitazone hydrochloride may slow the growth of tumor cells and may be an effective treatment for non-small cell lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the mechanism(s) of action of pioglitazone as a candidate chemopreventive agent for lung cancer by investigating the effects on Ki-67 defined in non-small cell lung cancer (NSCLC) tumor tissue.

SECONDARY OBJECTIVES:

I. To determine the effects of pioglitazone on multiple markers listed below:

* Tumor tissue: caspase-3, cyclin D1, p21/Waf1, peroxisome proliferative activated receptor, gamma (PPARγ), mucin 1 (MUC1).
* Premalignant tissue: Ki-67, caspase-3, PPARγ.
* Histologically normal tissue: Ki-67, PPARγ. II. To evaluate the toxicity and safety of pioglitazone in this patient population.

III. To analyze the expression of serum markers that are affected by pioglitazone.

IV. To describe the effects of limited treatment with pioglitazone on tumor metabolic activity as determined by FDG-PET (assessed before and after a minimum of 2 weeks of treatment).

OUTLINE:

Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 14-42 days. Patients then undergo surgery.

Arms: arm 1: Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Pioglitazone Hydrochloride intervention 3: Quality-of-Life Assessment
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Ancillary studies

Protocol documents:
Clinical trial NCT01368809
Conditions: Ambulatory Surgery Coughing
Keywords: Ambulatory surgery Pain management Perioperative outcomes Fentanyl Coughing during insertion of an LMA Ambulatory surgery procedures
Sponsor: Cedars-Sinai Medical Center
Start date: 2011-06-01; Completion date: 2013-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to evaluate the effectiveness of fentanyl for reducing coughing during the perioperative period (i.e., insertion of an LMA \[Laryngeal Mask Airway\] device, maintenance period during surgery, and awakening \[emergence\] from general anesthesia) for ambulatory surgery procedures. Also to assess the effects of fentanyl on the postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel function \[constipation\], resumption of normal activities of daily living).

Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because of its anesthetic-sparing effects and alleged ability to reduce coughing during instrumentation of the patient's airway.

Detailed description:
This research study is designed to evaluate the effects of fentanyl when administered as an adjuvant to standard anesthetic and analgesic drugs on coughing (during insertion of an LMA device, during maintenance and emergence from general anesthesia) and on the postoperative adverse outcomes (i.e., side effects).

All patients will receive local anesthetics and commonly used non-opioid pain relieving medications during surgery.

Arms: arm 1: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed arm 2: Saline Solution 2 ml at induction, 1-2 ml boluses as needed
Interventions: intervention 1: Saline intervention 2: Fentanyl
Intervention descriptions: intervention 1: 2 ml at induction 1-2 ml boluses as needed intervention 2: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed

Protocol documents:
Clinical trial NCT01386125
Conditions: Nasal Polyps
Sponsor: Organon and Co
Start date: 2011-06-01; Completion date: 2013-02-01
Enrollment: 748 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.

Detailed description:

Arms: arm 1: Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks arm 2: Participants receive matching placebo nasal spray BID for 16 weeks
Interventions: intervention 1: Mometasone Furoate Nasal Spray (MFNS) intervention 2: Placebo for MFNS
Intervention descriptions: intervention 1: MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks intervention 2: Two sprays in each nostril BID for up to 16 weeks

Protocol documents:
Clinical trial NCT01403051
Conditions: HIV-1 Infection
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2011-09-01; Completion date: 2013-02-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common for people who are taking HIV drugs for the first time. The risks seen with this HIV treatment are the same that you would encounter when taking these drugs outside of the study. The lists of risks of this HIV treatment are included in this document because the drugs are provided by the study, not because the drugs are being tested. The purpose of the study is only to look at the impact of high doses of vitamin D and calcium in preventing bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF).

Detailed description:

Arms: arm 1: Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), calcium carbonate and vitamin D3 4000 IU. arm 2: Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), a placebo for calcium carbonate, and a placebo for vitamin D3.
Interventions: intervention 1: EFV/FTC/TDF intervention 2: Calcium Carbonate intervention 3: Vitamin D3 intervention 4: Placebo for calcium carbonate intervention 5: Placebo for vitamin D3
Intervention descriptions: intervention 1: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach. intervention 2: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks. intervention 3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks. intervention 4: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks intervention 5: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Protocol documents:
Clinical trial NCT01414166
Conditions: Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-09-01; Completion date: 2013-02-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.

Detailed description:

Arms: arm 1: All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT for 16 weeks. arm 2: All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive placebo for 16 weeks.
Interventions: intervention 1: ERN/LRPT intervention 2: placebo
Intervention descriptions: intervention 1: ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks intervention 2: ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks

Protocol documents:
Clinical trial NCT01424033
Conditions: Interstitial Lung Disease Connective Tissue Disease
Keywords: Interstitial lung disease Connective tissue disease Scleroderma Rheumatoid arthritis Sjogren's syndrome Mixed connective tissue disease Dermatomyositis Polymyositis Systemic lupus erythematosis
Sponsor: University of Michigan
Start date: 2011-12-01; Completion date: 2013-02-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The first objective of this protocol is to assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD).

Detailed description:
The investigators will assess tolerability and safety at scheduled intervals via standard of care physical exam findings, monitoring complete blood count, serum chemistry, and pulmonary function tests, along with patient reports of medication intolerance and change in symptoms of dyspnea.

Arms: arm 1: This is an open label trial, all patient will be entered into one treatment arm.
Interventions: intervention 1: N-Acetylcysteine
Intervention descriptions: intervention 1: 600mg by mouth, three times daily for 12 months

Protocol documents:
Clinical trial NCT01449682
Conditions: Retinal Vein Occlusion Macular Edema
Keywords: BRVO CRVO Macular Edema Anti-VEGF Ozurdex
Sponsor: Retina Macula Institute
Start date: 2011-10-01; Completion date: 2013-02-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.

Detailed description:
The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.

Arms: arm 1: 0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT arm 2: 0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
Interventions: intervention 1: Ozurdex intervention 2: Ozurdex
Intervention descriptions: intervention 1: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies intervention 2: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks

Protocol documents:
Clinical trial NCT01451723
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Polyphenon E Green tea EGCG Epigallocatechin-galleate Placebo Randomized controlled trial
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Start date: 2011-07-01; Completion date: 2013-02-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate (a chemical that reflects the number of neurons and their metabolism) over one year between people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.

Detailed description:
This will be a double blind placebo controlled trial of Polyphenon E as a treatment for MS.

The primary outcome will be the changes in NAA levels over one year. Secondary outcomes will be changes in brain atrophy over one year. As an exploratory outcome we will correlate changes in NAA levels with free Plasma levels of EGCG 8 hours after the morning dose.

Exploratory outcomes include disability progression by EDSS, MS functional composite components and a cognitive test battery.

Arms: arm 1: Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food. arm 2: Matching placebo capsules.
Interventions: intervention 1: Polyphenon E intervention 2: Placebo
Intervention descriptions: intervention 1: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food. intervention 2: Matching placebo capsules

Protocol documents: