ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00796510
Conditions: Pulmonary Arterial Hypertension Pulmonary Hypertension
Keywords: endothelin receptor antagonist (ETRA) sitaxsentan
Sponsor: Pfizer
Start date: 2010-07-01; Completion date: 2011-01-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.

Detailed description:

Arms: arm 1: Monotherapy arm arm 2: Combination treatment
Interventions: intervention 1: Sitaxsentan intervention 2: Sitaxsentan and Sildenafil
Intervention descriptions: intervention 1: Sitaxsentan = 100 mg tablet administered orally, once daily intervention 2: Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Protocol documents:
Clinical trial NCT00800683
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-12-01; Completion date: 2011-01-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
to determine safety, efficacy and tolerability of BI 1356 versus placebo

Detailed description:

Arms: arm 1: patient to receive a tablet containing BI 1356 once daily arm 2: patient to receive a tablet identical to BI 1356 once daily
Interventions: intervention 1: BI 1356 intervention 2: placebo
Intervention descriptions: intervention 1: BI 1356 dosed once daily intervention 2: placebo matching BI 1356 taken once daily

Protocol documents:
Clinical trial NCT00813917
Conditions: Nicotine Dependence
Sponsor: Mayo Clinic
Start date: 2009-02-01; Completion date: 2011-01-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.

Detailed description:
In the United States, approximately 7.7 million individuals older than 12 years of age report current (past month) use of smokeless tobacco (ST). ST use has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular disease. To date, no pharmacotherapies have been shown to increase long-term (≥ 6 months) abstinence rates in ST users. Novel pharmacotherapies that decrease withdrawal symptoms and nicotine self-administration need to be tested in ST users. Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users. To evaluate this hypothesis, we will conduct a pilot study to obtain preliminary estimates of efficacy of 12-weeks of varenicline for increasing the prolonged and point prevalence tobacco abstinence rates at 12 weeks (end-of-treatment) in ST users. We will also evaluate the effect of varenicline on nicotine withdrawal symptoms and tobacco craving. If the results are promising, we will plan for a multicenter, randomized, double-blinded, placebo-controlled clinical trial with the Oregon Research Institute in Eugene, OR, to investigate the efficacy of varenicline to increase long-term (≥ 6 months) abstinence rates in ST users.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: 12 weeks of varenicline 1 mg by mouth twice per day intervention 2: 12 weeks of placebo (double blinded) by mouth twice per day

Protocol documents:
Clinical trial NCT00818324
Conditions: Dry Eye Syndromes
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-01-01; Completion date: 2011-01-01
Enrollment: 154 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Detailed description:

Arms: arm 1: Instillation, 4times/day
Interventions: intervention 1: OPC-12759 Ophthalmic suspension
Intervention descriptions: intervention 1: Instillation,4times/day,for 52weeks

Protocol documents:
Clinical trial NCT00820898
Conditions: Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Recurrent Uterine Corpus Carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2009-02-01; Completion date: 2011-01-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed higher priority treatment protocols.

II. To determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Gemcitabine Hydrochloride
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00832117
Conditions: Non Small Cell Lung Cancer
Keywords: Lung Cancer (NSCLC)
Sponsor: R-Pharm
Start date: 2009-05-01; Completion date: 2011-01-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ixabepilone intervention 2: Cisplatin intervention 3: Ixabepilone intervention 4: Cisplatin
Intervention descriptions: intervention 1: Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months intervention 2: Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months intervention 3: Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months intervention 4: Expansion: Solution, IV, 60-80 mg/m2, every 3 weeks, approximately 6 months

Protocol documents:
Clinical trial NCT00846495
Conditions: Migraine
Keywords: Migraine Migraine prevention Prodrome Premonitory phase Preemptive therapy
Sponsor: Clinvest
Start date: 2009-08-01; Completion date: 2011-01-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

Detailed description:

Arms: arm 1: Subjects randomized to Group A at Visit 2 were provided with topiramate, titrated over 4 weeks to a maximum dose of 100 mg daily. One dosage adjustment was allowed with a minimum dose of 50 mg daily. arm 2: Subjects randomized to Group B at Visit 2 were provided with frovatriptan 5 mg to treat during prodrome at the point they were confident a disabling migraine would occur (before the onset of headache).
Interventions: intervention 1: topiramate intervention 2: frovatriptan
Intervention descriptions: intervention 1: topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks intervention 2: frovatriptan 5mg tab during premonitory phase of migraine

Protocol documents:
Clinical trial NCT00854620
Conditions: Carcinoma, Renal Cell Kidney Disease Kidney Cancer
Sponsor: Stanford University
Start date: 2007-12-01; Completion date: 2011-01-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib

Detailed description:
Sorafenib to be administered as 28-day cycles.

Sorafenib dose escalation by cycle is:

* Cycle 1: 400 mg BID
* Cycle 2: 600 mg BID
* Cycle 3+: 800 mg BID

Within subject dose escalation and maximum dose is dependent on observed tolerability.

Dose escalation only occurs after acceptable tolerability is demonstrated by subject.

Arms: arm 1: * Cycle 1: 400 mg BID sorafenib
* Cycle 2: 600 mg BID sorafenib
* Cycle 3+: 800 mg BID sorafenib
Interventions: intervention 1: Sorafenib
Intervention descriptions: intervention 1: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)

Protocol documents:
Clinical trial NCT00855868
Conditions: Alzheimer's Disease
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2009-03-01; Completion date: 2011-01-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the performance characteristics of a novel \[18F\] amyloid detection ligand (18F\]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of \[11C\]PIB to correctly categorize the same subjects.

SPECIFIC HYPOTHESES

1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of \[18F\]-AV-45 compared to cognitively normal elderly individuals.
2. There will be no clinically meaningful difference in the amyloid retention performance characteristics of \[18F\]-AV-45 and \[l1C\]PIB.

Detailed description:
15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both \[18F\]-AV-45 and \[11C\]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.

Interventions: intervention 1: florbetapir F 18 intervention 2: [11C]-PIB
Intervention descriptions: intervention 1: 370 MBq (10 mCi), intravenous (IV) injection, single dose intervention 2: 555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB

Protocol documents:
Clinical trial NCT00858832
Conditions: Endometritis
Sponsor: University of South Florida
Start date: 2008-12-01; Completion date: 2011-01-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can prolong the woman's stay in the hospital after birth, slow down her recovery time at home, and increase medical costs. Methergine is a medication that is routinely used to stop uterine hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery. Methergine works by contracting (tightening) the uterus. These contractions also help the uterus to expel or remove parts of the placenta that increase the chance of developing a uterine infection.

This research study is being done to learn if routine use of Methergine can lower the chances of developing a uterine infection after cesarean delivery. Half of the women in this study will receive Methergine for a few days during their hospitalization after cesarean delivery. The other half of the women will not routinely receive Methergine.

Detailed description:

Arms: arm 1: Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care. arm 2: No treatment group received only routine postpartum care.
Interventions: intervention 1: Methergine
Intervention descriptions: intervention 1: Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay

Protocol documents:
Clinical trial NCT00867217
Conditions: Breast Cancer
Sponsor: Qamar Khan
Start date: 2009-03-01; Completion date: 2011-01-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

Detailed description:
The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,

Arms: arm 1: High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). arm 2: Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).
Interventions: intervention 1: High Dose Vitamin D intervention 2: Placebo intervention 3: Standard Dose Vitamin D3 intervention 4: Letrozole 2.5mg
Intervention descriptions: intervention 1: High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks. intervention 2: Placebo comparator intervention 3: Standard Dose Vitamin D3 (600 IU of vitamin D3 daily) intervention 4: All subjects received letrozole as standard of care.

Protocol documents:
Clinical trial NCT00869089
Conditions: Prurigo Nodularis
Keywords: PN
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2008-09-01; Completion date: 2011-01-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will include:

* Study period up to 7 months.
* Office visits monthly lasting approximately 1 hour.
* Blood Draws.
* Oral medication that is taken 2 times daily.
* Photographs and biopsies if agreed.

Detailed description:

Arms: arm 1: CC-10004 treament:

30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
Interventions: intervention 1: CC-10004
Intervention descriptions: intervention 1: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)

Protocol documents:
Clinical trial NCT00874770
Conditions: Hepatitis C Infection
Keywords: Antivirals
Sponsor: Bristol-Myers Squibb
Start date: 2009-06-01; Completion date: 2011-01-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

Detailed description:

Arms: arm 1: Active Comparator arm 2: Active Comparator arm 3: Active Comparator arm 4: None
Interventions: intervention 1: Daclatasvir intervention 2: Daclatasvir intervention 3: Daclatasvir intervention 4: Placebo intervention 5: Peginterferon alpha-2a intervention 6: ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 3 mg, Daily, 48 weeks intervention 2: Tablets, oral, 10 mg, Daily, 48 weeks intervention 3: Tablets, oral, 60 mg, Daily, 48 weeks intervention 4: Tablet, oral, 0 mg, Daily 48 weeks intervention 5: Syringe, subcutaneous, 180 µg, Weekly, 48 weeks intervention 6: Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks

Protocol documents:
Clinical trial NCT00875550
Conditions: Sedation
Keywords: Intubated and mechanically ventilated PICU subjects
Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Start date: 2010-01-01; Completion date: 2011-01-01
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key study objectives are:

* To characterize the loading and maintenance dosing of DEX by age group and overall medical condition of pediatric subjects
* To evaluate the safety and efficacy of loading and maintenance infusions for sedation in initially intubated and mechanically ventilated PICU subjects
* To explore the exposure-response relationship between dose of DEX and clinical measures of sedation and safety

Detailed description:
An estimated 175 subjects will be enrolled at approximately 40 investigative sites. Subjects will be divided into two treatment groups to receive either high dose or low dose Dexmedetomidine (DEX). The loading and maintenance doses in both groups will be stratified according to the presence or absence of cardiopulmonary bypass. The level of sedation will be assessed using the University of Michigan Sedation Scale (UMSS). Score 0 (awake/alert); Score 1 (sleepy/responds appropriately); Score 2 (somnolent/arouses to light stimuli); Score 3 (deep sleep/arouses to deeper); Score 4 (unarousable to stimuli).

Based on these scores and clinical judgment, additional sedation with intravenous midazolam will be administered according to the label. The UMSS scores must be documented before the administration of every midazolam (MDZ) dose and within five minutes after each dose of MDZ. Fentanyl or morphine may be administered to treat pain. Subjects may be extubated after beginning of study drug but are not required to be as part of the study.

The efficacy and safety parameters that will be monitored include sedation levels, heart rate, blood pressure and ventilation indicators. Once subjects have met site-specified respiratory criteria, they will undergo tracheal extubation. The dexmedetomidine infusion may be continued during and after extubation if further sedation is required post-extubation. The continuous infusion of dexmedetomidine must be administered for a minimum of 6 hours and a maximum of 24 hours. Sedation levels, heart rate, blood pressure, respiratory rate, ventilator settings, SpO2 and if available transcutaneous carbon dioxide (TcCO2) and/or arterial blood gases (ABG) will be monitored and recorded in the peri-extubation period.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dexmedetomidine intervention 2: Midazolam intervention 3: Fentanyl intervention 4: Morphine
Intervention descriptions: intervention 1: Study drug titrated up or down to maintain target UMSS range. intervention 2: Rescue medication for sedation according to UMSS scores intervention 3: Rescue medication for pain based on UMSS scores intervention 4: Rescue medication for pain based on UMSS scores.

Protocol documents:
Clinical trial NCT00880568
Conditions: Neoplasms Malignant
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-01; Completion date: 2011-01-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.

Detailed description:

Arms: arm 1: Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle arm 2: Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle arm 3: Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle arm 4: Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle arm 5: Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle arm 6: Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle arm 7: Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle arm 8: Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle arm 9: Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Interventions: intervention 1: MK-1496 intervention 2: MK-1496
Intervention descriptions: intervention 1: MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle intervention 2: MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle

Protocol documents: