ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01097330
Conditions: Defibrillators, Implantable Tachycardia, Ventricular
Keywords: Defibrillators, Implantable Tachycardia, Ventricular Catheter Ablation Amiodarone
Sponsor: Population Health Research Institute
Start date: 2010-08-01; Completion date: 2012-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This study is designed to determine the best way to manage patients who have an ICD and who continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and 2) Medication.

An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area and threading it into the heart. After the doctor has located the affected area responsible for the VT, radiofrequency energy is delivered by the power generator through the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart tissue thought to cause the VT.

A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart rhythms from recurring.

The purpose of this study is to compare these two different methods for treating VT. Treatment with ablation and amiodarone are both considered the standard of care for patients with VT but they have not been compared directly in a study like this before.

Detailed description:

Arms: arm 1: Catheter based radiofrequency ablation for ischemic ventricular tachycardia arm 2: amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.
Interventions: intervention 1: Ablation intervention 2: Amiodarone
Intervention descriptions: intervention 1: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization intervention 2: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study

Protocol documents:
Clinical trial NCT01116687
Conditions: Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-05-01; Completion date: 2012-03-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well RO4929097 works in treating patients with metastatic colorectal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective radiographic response rate associated with RO4929097 in patients with metastatic colorectal cancer who have progressed following at least two prior treatments in the metastatic setting.

SECONDARY OBJECTIVES:

I. To determine the progression-free survival (PFS) and overall survival (OS) associated with this agent.

II. To determine the safety and tolerability of RO4929097 in this patient population.

III. To assess whether response correlates with up regulation of the Notch pathway, to be determined through immunohistochemical analysis of Notch1, ICN and HES1 on available paraffin-embedded tissue samples (exploratory aim).

OUTLINE:

Participants will take 20 mg of RO4929097 by mouth at home in the morning for 3 days and then not take it for 4 days, continuously. The tablet is to be taken at approximately the same time the days they take it on an empty stomach, 1 hour before a meal or 2 hours after a meal. Participants will be asked to keep a "pill diary" recording each dose of study drug (including missed, skipped, or vomited doses) and return the diary to the study staff each visit. Participants will be informed that tablets should not be broken or opened; that they should avoid eating grapefruits or drinking grapefruit juice while on the study; that if they miss a dose of study drug, they should not try to make up that dose; that instead, they should wait until their next scheduled dose. Participants will see their study doctor and undergo standard blood work (approximately 12 mL) every 4 weeks. During these visits, participants will be asked about side effects of the RO4929097 and undergo a physical examination. Participants will continue taking the RO4929097 as long as they are tolerating it and as long as the cancer is shrinking or remains stable.

Arms: arm 1: See detailed description.
Interventions: intervention 1: gamma-secretase/Notch signalling pathway inhibitor RO4929097 intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01127581
Conditions: Reducing Time to Vaginal Delivery Cervical Ripening Induction of Labor
Keywords: Misoprostol vaginal insert Dinoprostone vaginal insert Cervidil Cervical ripening Induction of labor Rate of cesarean section
Sponsor: Ferring Pharmaceuticals
Start date: 2010-09-01; Completion date: 2012-03-01
Enrollment: 1358 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.

Detailed description:

Arms: arm 1: MVI 200 mcg vaginal insert arm 2: 10 mg Dinoprostone vaginal insert
Interventions: intervention 1: MVI 200 intervention 2: Dinoprostone Vaginal Insert (DVI)
Intervention descriptions: intervention 1: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. intervention 2: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.

Protocol documents:
Clinical trial NCT01128543
Conditions: Cancer
Keywords: lapatinib breast cancer
Sponsor: GlaxoSmithKline
Start date: 2009-04-01; Completion date: 2012-03-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting.

Detailed description:
This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting.

Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Day 8, every 3 week for 24 weeks. The study treatment will continue until patients experience disease progression or unacceptable toxicity. The primary objective of the study is the objective response rate (ORR, defined as CR + PR) and toxicity. Secondary objectives include DFS, duration of response.

Arms: arm 1: Patients will receive 1250mg lapatinib once a day for 24 weeks. arm 2: Patients will receive vinorelbine 25mg/sqm IV Day 1 and Day 8, every 3 week for 24 weeks.
Interventions: intervention 1: lapatinib and Vinorelbine
Intervention descriptions: intervention 1: Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Day 8, every 3 week for 24 weeks.

Protocol documents:
Clinical trial NCT01136356
Conditions: Opioid Abuse Opioid Dependence
Keywords: opioid pharmacology buprenorphine morphine withdrawal human research
Sponsor: Johns Hopkins University
Start date: 2010-07-01; Completion date: 2012-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.

Detailed description:

Arms: arm 1: Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above. arm 2: Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day). Participants then underwent an 18-day period of spontaneous withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.
Interventions: intervention 1: buprenorphine intervention 2: morphine
Intervention descriptions: intervention 1: parenteral buprenorphine may be administered at multiple times each day intervention 2: parenteral morphine may be administered multiple times each day

Protocol documents:
Clinical trial NCT01142128
Conditions: Chronic Pancreatitis
Sponsor: University of Florida
Start date: 2009-02-01; Completion date: 2012-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.

Detailed description:

Arms: arm 1: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium arm 2: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium arm 3: Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month. arm 4: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
Interventions: intervention 1: Nexium (esomeprazole magnesium) intervention 2: Placebo to Nexium intervention 3: Viokase 16 (pancrelipase) + Nexium intervention 4: Viokase 16 + placebo to Nexium
Intervention descriptions: intervention 1: one 40 mg capsule per day for one month intervention 2: one capsule per day for one month intervention 3: Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month intervention 4: Viokase 16 pancrelipase tablets are given per day for one month with one capsule of placebo to esomeprazole magnesium, one per day for one month

Protocol documents:
Clinical trial NCT01143337
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2010-06-01; Completion date: 2012-03-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses of Methotrexate.

Detailed description:

Arms: arm 1: dose1 arm 2: Placebo
Interventions: intervention 1: MP-435(dose1) + Methotrexate intervention 2: Placebo + Methotrexate
Intervention descriptions: intervention 1: MP-435 dose1 + stable weekly dose of Methotrexate intervention 2: Placebo + stable weekly dose of Methotrexate

Protocol documents:
Clinical trial NCT01152437
Conditions: Colorectal Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2010-06-01; Completion date: 2012-03-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.

Detailed description:

Arms: arm 1: Patients receive BIBW 2992 tablets once daily arm 2: Patients receive cetuximab intravenously once a week, every week
Interventions: intervention 1: BIBW 2992 intervention 2: Cetuximab
Intervention descriptions: intervention 1: Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management intervention 2: Patients receive cetuximab intravenously, once a week, every week

Protocol documents:
Clinical trial NCT01153009
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder Depression Melancholia Drug Therapy
Sponsor: Takeda
Start date: 2010-06-01; Completion date: 2012-03-01
Enrollment: 614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

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

The study enrolled 614 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 15 mg
* Vortioxetine 20 mg
* Duloxetine 60 mg
* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.

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

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

Arms: arm 1: Placebo-matching capsules, orally, once daily for up to 9 weeks. arm 2: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week. arm 4: Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Interventions: intervention 1: Vortioxetine intervention 2: Duloxetine intervention 3: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate release tablets intervention 2: Overencapsulated duloxetine delayed-release capsules intervention 3: Placebo-matching capsules

Protocol documents:
Clinical trial NCT01156311
Conditions: Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis
Keywords: BG00012 MS RRMS
Sponsor: Biogen
Start date: 2010-06-01; Completion date: 2012-03-01
Enrollment: 108 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).

Detailed description:

Arms: arm 1: Participants taking a stable dose of GA for at least 12 months prior to the study remain on that dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months). arm 2: Participants taking a stable dose of one of the IFNβ products for at least 12 months prior to the study remain on that product and dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
Interventions: intervention 1: dimethyl fumarate
Intervention descriptions: intervention 1: Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.

Protocol documents:
Clinical trial NCT01174043
Conditions: Leukemia, Myelomonocytic, Acute
Keywords: Leukemia, Myelomonocytic, Acute Erlotinib
Sponsor: Indiana University
Start date: 2010-07-01; Completion date: 2012-03-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is looking for patients with newly diagnosed acute myeloid leukemia (AML), AML that has returned (relapsed), or it has not responded adequately to previous treatments. Treating certain patients with chemotherapy may not be to their benefit or may cause more harm than benefit. The purpose of this study is to find out what effects (good and bad) erlotinib has on patients and their AML.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.

Protocol documents:
Clinical trial NCT01175226
Conditions: Rhinovirus
Keywords: Human rhinovirus Aviragen Therapeutics, Inc. Aviragen Therapeutics Aviragen
Sponsor: Biota Scientific Management Pty Ltd
Start date: 2010-08-01; Completion date: 2012-03-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on

* shortening the length and reducing the symptoms of human rhinovirus infection (also known as the common cold),
* controlling asthma symptoms, and
* lowering the risk of asthma symptoms worsening in subjects with asthma.

Detailed description:
Subjects with a previous diagnosis of asthma will be pre screened within 90 days prior to enrolment. If a subject develops symptoms of human rhinovirus (HRV) infection they will visit the site for assessment. Symptomatic subjects meeting all eligibility criteria will be invited to enroll.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BTA798 intervention 2: Placebo
Intervention descriptions: intervention 1: BTA798 twice daily intervention 2: Placebo twice daily

Protocol documents: