ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01026818
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction Radical Prostatectomy
Sponsor: Eli Lilly and Company
Start date: 2009-11-01; Completion date: 2012-10-01
Enrollment: 583 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.

Detailed description:

Arms: arm 1: After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period. arm 2: After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period. arm 3: After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by mouth for 9 months intervention 2: Administered by mouth, daily or on demand for 9 months

Protocol documents:
Clinical trial NCT01174160
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Sponsor: Advanz Pharma
Start date: 2010-08-01; Completion date: 2012-10-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.

Detailed description:
Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.

Arms: arm 1: vernakalant hydrochloride arm 2: placebo
Interventions: intervention 1: vernakalant hydrochloride intervention 2: Placebo to vernakalent hydrochloride
Intervention descriptions: intervention 1: Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered. intervention 2: Patients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered.

Protocol documents:
Clinical trial NCT01323478
Conditions: Major Depressive Disorder
Keywords: Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioural Symptoms
Sponsor: H. Lundbeck A/S
Start date: 2011-04-01; Completion date: 2012-10-01
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Vortioxetine (Lu AA21004)
Intervention descriptions: intervention 1: 15 or 20 mg/day; tablets; orally

Protocol documents:
Clinical trial NCT01324128
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: PA21 Phosphate Binder
Sponsor: Vifor Pharma
Start date: 2011-03-01; Completion date: 2012-10-01
Enrollment: 1059 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: PA21 (2.5 g tablet containing 500 mg iron) intervention 2: Sevelamer carbonate intervention 3: PA21-1 (1.25 g tablet containing 250 mg iron)
Intervention descriptions: intervention 1: Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). intervention 2: Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day) intervention 3: Low dose comparator (1.25 g/day)

Protocol documents:
Clinical trial NCT01431521
Conditions: Non-alcoholic Fatty Liver Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-10-26; Completion date: 2012-10-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate changes in liver fat content following multiple oral doses of MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease. The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction in hepatic fat with respect to placebo is expected).

Detailed description:

Arms: arm 1: Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks. arm 2: Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks. arm 3: Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks. arm 4: Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
Interventions: intervention 1: MK-4074 200 mg intervention 2: Placebo for MK-4074 intervention 3: Pioglitazone hydrochloride 30 mg intervention 4: Placebo for pioglitazone hydrochloride
Intervention descriptions: intervention 1: 2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks intervention 2: 2 x 100-mg capsules, orally, BID for 4 weeks. intervention 3: 1 x 30-mg tablet, orally, once daily for 4 weeks intervention 4: 1 x 30-mg tablet, orally, once daily for 4 weeks

Protocol documents:
Clinical trial NCT00054691
Conditions: Skin Cancer
Keywords: Skin Cancer Squamous Cell Carcinoma of the Skin Gefitinib ZD1839 Iressa Epidermal Growth Factor Receptor EGFR
Sponsor: M.D. Anderson Cancer Center
Start date: 2004-05-01; Completion date: 2012-10-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if the drug ZD1839 (Iressa) can shrink or slow the growth of cancer in participants with recurrent and/or metastatic squamous cell cancer (SCC) of the skin. The safety of this drug will also be studied.

Detailed description:
ZD1839 is a new drug that may slow or stop cell growth in humans.

Epidermal growth factor receptor (EGFR) may be involved in certain types of cancer, including squamous cell carcinoma of the skin. When EGFR is stimulated, a series of chemical reactions starts that results in a tumor being "told" to grow. ZD1839 tries to stop these reactions by blocking EGFR. This may stop tumors from growing.

In this study, participants will take ZD1839 by mouth daily. Once the treatment has started, participants will return to the clinic before every treatment cycle (every 4 weeks) for the first 4 months then every 8 weeks thereafter. At these visits, participants will have a physical exam and blood tests will be performed. About 2-4 teaspoons of blood will be drawn at each visit. The doctor will also check on how participants are tolerating ZD1839 (side effects). Every 8 weeks, participants will have their tumor evaluated by radiographic scans. This may include either a CT or MRI and a chest X-ray.

During treatment, participants should not take any other medication, including non-prescription drugs such as aspirin or herbal products without the approval of their doctor.

Participants will continue taking the trial drug until the tumor grows, a severe side effect occurs, they withdraw consent, or the study is closed. The study will be closed 12 months after the last participant is enrolled.

This is an investigational study. The FDA has approved ZD1839 for the treatment of advanced lung cancer, but the FDA has authorized ZD1839 for research only in the treatment of skin cancer. About 40 participants will take part in this study. All will be enrolled at M.D. Anderson.

Arms: arm 1: Iressa (ZD1839) 250 mg by mouth daily.
Interventions: intervention 1: Iressa
Intervention descriptions: intervention 1: 250 mg by mouth daily

Protocol documents:
Clinical trial NCT00075881
Conditions: Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: National Cancer Institute (NCI)
Start date: 2004-01-01; Completion date: 2012-10-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response rate to PS-341 (bortezomib) induction in patients with high risk, newly diagnosed multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate progression free survival. II. To explore the response rate of patients who relapse or progress on maintenance and then return to induction schedule.

III. To explore duration of second response.

TERTIARY OBJECTIVES:

I. To explore a possible differential response to PS-341 with previously described adverse prognostic indicators.

II. To explore specific gene expression profiles (GEP) that may predict response to therapy to an agent or combination of agents used in the treatment of newly diagnosed myeloma.

III. To explore specific post-treatment gene expression profiles (GEP) in the patients who have received 4 cycles of therapy and achieved a minimal response or better.

IV. To develop relevant information about the immune system for multiple myeloma patients treated with PS-341.

OUTLINE:

INDUCTION TREATMENT: Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE TREATMENT: Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REINDUCTION TREATMENT: Patients who progress while on maintenance treatment receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 4 years.

Arms: arm 1: INDUCTION TREATMENT: Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE TREATMENT: Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REINDUCTION TREATMENT: Patients who progress while on maintenance treatment receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: bortezomib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Optional correlative studies

Protocol documents:
Clinical trial NCT00162370
Conditions: Coronary Artery Disease Heart Disease
Sponsor: Lantheus Medical Imaging
Start date: 2004-04-01; Completion date: 2012-10-01
Enrollment: 400 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is designed to see if stress echocardiography can be used as a screening exam in peri-, or post-menopausal women with a risk of developing of coronary artery disease and experiencing future cardiac events.

Detailed description:
The clinical trial is designed to determine the prognostic value of stress echocardiography as a screening examination in peri-, or post-menopausal female patients with an intermediate likelihood of coronary artery disease (CAD) based on risk factors to identify patients at higher risk of experiencing future cardiac events.Female patients who are able to adequately exercise will undergo a symptom-limited exercise echocardiogram. Patients who are unable to adequately exercise or are predicted to be unable to exercise adequately (because of orthopedic/neurologic limitations, lung disease or debility), will perform dobutamine stress echocardiography. All patients will receive DEFINITY at rest and stress to enhance wall motion assessment.

Arms: arm 1: All patients will undergo a gray scale baseline unenhanced imaging session (apical 2- or 4 chamber view), as well as a DEFINITY (Perflutren Lipid Microsphere Injectable Suspension)-enhanced rest and a DEFINITY enhanced exercise or dobutamine stress echocardiography imaging session. The unenhanced and DEFINITY-enhanced rest and stress echocardiography imaging sessions will be performed on the same day. For the DEFINITY-enhanced imaging sessions all patients will receive diluted DEFINITY intravenously (IV). Diluted DEFINITY will be prepared by mixing 1 mL of activated DEFINITY® with 9 mL of normal saline in a 10 mL syringe.
Interventions: intervention 1: Perflutren Lipid Microsphere Injectable Suspension
Intervention descriptions: intervention 1: Activated DEFINITY 10ug/kg by bolus injection

Protocol documents:
Clinical trial NCT00209092
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: Emory University
Start date: 2006-08-01; Completion date: 2012-10-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Detailed description:
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment. Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Arms: arm 1: Docetaxel will be given at 100mg/m\^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks). arm 2: Docetaxel will be given at 50mg/m\^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
Interventions: intervention 1: Docetaxel intervention 2: Capecitabine
Intervention descriptions: intervention 1: Sequential Therapy: Docetaxel will be given at 100 mg/m\^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles.

Concurrent Therapy: Docetaxel will be given at 50 mg/m\^2 IV Day 1. intervention 2: Sequential Therapy: administration of capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Protocol documents:
Clinical trial NCT00301808
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2005-11-01; Completion date: 2012-10-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel.

Secondary

* Assess the progression-free survival and overall survival.
* Assess the toxicity of this regimen.

OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses.

After completion of study therapy, patients are followed at 1 month and periodically thereafter.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Arms: arm 1: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Interventions: intervention 1: Cisplatin intervention 2: Docetaxel intervention 3: Pemetrexed disodium intervention 4: Radiation therapy
Intervention descriptions: intervention 1: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43 intervention 2: Docetaxel 75 mg/m2 on day 1 of each cycle intervention 3: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43 intervention 4: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.

Protocol documents:
Clinical trial NCT00321594
Conditions: Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-05-01; Completion date: 2012-10-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of belinostat and to see how well it works in treating patients with liver cancer that cannot be removed by surgery. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD) of PXD101 (belinostat) in patients with unresectable hepatocellular carcinoma (HCC). (Phase I) II. Assess the pharmacokinetic profiles of PXD101 in these patients. (Phase I) III. Assess tumor response in patients treated with this drug. (Phase II)

OUTLINE: This is a multicenter, dose-escalation phase I study followed by a phase II study.

PHASE I: Patients receive belinostat intravenously (IV) over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of belinostat until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PHASE II: Patients receive belinostat (as in phase I) at the MTD determined in phase I.

After completion of study therapy, patients are followed for up to 8 weeks.

Arms: arm 1: Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: belinostat
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00351299
Conditions: Delirium Agitation
Keywords: Delirium Agitation Sedation Dexmedetomidine Surgical
Sponsor: Brigham and Women's Hospital
Start date: 2006-01-01; Completion date: 2012-10-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium

Detailed description:
Delirium is a mental disturbance that causes people to be confused and restless for a period of time. We will compare dexmedetomidine to the traditional therapy for treatment of acute delirium. Dexmedetomidine does not affect breathing. The traditional drugs might make one sleepy and may slow down breathing. The traditional therapy in this institution for acute delirium is \_the use of Haloperidol, and/or benzodiazepines. Haloperidol is an antipsychotic drug that has calming effect. Benzodiazepines are sedatives with calming effect.Dexmedetomidine is approved by the Food and drug Administration (FDA) to sedate patients on a breathing machine for 24 hours.

Arms: arm 1: infusion 0.3-0.7 dexmedetomidine arm 2: Standard of care per treating physician preference
Interventions: intervention 1: Dexmedetomidine intervention 2: Standard of Care
Intervention descriptions: intervention 1: dexmedetomidine infusion titrated to effect intervention 2: Standard of care per treating physician preference

Protocol documents: