ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00453310
Conditions: Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor
Keywords: recurrent ovarian germ cell tumor stage IV ovarian germ cell tumor ovarian choriocarcinoma ovarian immature teratoma ovarian mature teratoma recurrent malignant testicular germ cell tumor testicular choriocarcinoma testicular seminoma testicular yolk sac tumor ovarian dysgerminoma ovarian embryonal carcinoma ovarian yolk sac tumor ovarian monodermal and highly specialized teratoma ovarian polyembryoma stage III malignant testicular germ cell tumor ovarian mixed germ cell tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and seminoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and yolk sac tumor testicular embryonal carcinoma and seminoma testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and yolk sac tumor with seminoma testicular embryonal carcinoma and yolk sac tumor testicular yolk sac tumor and teratoma with seminoma testicular yolk sac tumor and teratoma testicular embryonal carcinoma recurrent extragonadal non-seminomatous germ cell tumor recurrent extragonadal seminoma stage IV extragonadal non-seminomatous germ cell tumor stage IV extragonadal seminoma recurrent extragonadal germ cell tumor testicular immature teratoma testicular mature teratoma adult teratoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-03-01; Completion date: 2008-11-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.

Secondary

* Determine the safety of this drug in these patients.
* Determine the time to tumor response and duration of tumor response in patients treated with this drug.

OUTLINE: This is a open-label study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 28 days and then periodically thereafter.

Arms: arm 1: The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00464737
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia Syndrome Rotigotine Neupro
Sponsor: UCB Pharma
Start date: 2007-03-01; Completion date: 2008-11-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed.

Detailed description:
The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo). No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Arms: arm 1: Placebo arm 2: 4 mg/24 hrs arm 3: 8 mg/24 hrs
Interventions: intervention 1: Rotigotine intervention 2: Rotigotine intervention 3: Placebo
Intervention descriptions: intervention 1: Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch) intervention 2: Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches) intervention 3: Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.

Protocol documents:
Clinical trial NCT00465517
Conditions: Partial Epilepsy Catamenial Epilepsy
Keywords: Partial onset seizures Complex-partial seizures Anticonvulsant Partial seizures Catamenial epilepsy
Sponsor: Marinus Pharmaceuticals
Start date: 2007-02-01; Completion date: 2008-11-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy.

Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.

Detailed description:

Arms: arm 1: active study drug arm 2: placebo
Interventions: intervention 1: Ganaxolone intervention 2: Placebo
Intervention descriptions: intervention 1: Oral suspension 200-500 mg 3x/day intervention 2: non-active placebo

Protocol documents:
Clinical trial NCT00469456
Conditions: Alzheimer's Disease
Keywords: memantine Alzheimer's Disease communication
Sponsor: Forest Laboratories
Start date: 2007-04-01; Completion date: 2008-11-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease

Detailed description:

Arms: arm 1: Memantine 20mg (10mg twice daily) oral administration for 12 weeks arm 2: Placebo oral administration twice daily for 12 weeks
Interventions: intervention 1: Memantine intervention 2: placebo
Intervention descriptions: intervention 1: Memantine 20mg (10mg twice daily) oral administration for 12 weeks intervention 2: Placebo oral administration twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00471354
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2007-04-01; Completion date: 2008-11-01
Enrollment: 228 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.

Detailed description:

Arms: arm 1: 0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.

Protocol documents:
Clinical trial NCT00473512
Conditions: Prostatic Neoplasms
Keywords: Abiraterone acetate CB7630 Prostatic neoplasms Hormone refractory prostate cancer Castration resistant prostate cancer Castration refractory prostate cancer
Sponsor: Cougar Biotechnology, Inc.
Start date: 2005-11-01; Completion date: 2008-11-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).

Detailed description:
This is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in participants with HRPC. The study will consist of a dose escalation stage (Phase 1) that will be conducted to determine the MTD of abiraterone and an activity evaluation stage (Phase 2) to evaluate the activity of abiraterone in participants with HRPC. Escalated doses of abiraterone (starting at 250 milligram \[mg\] up to a maximum of 2000 mg) will be given for 28-day treatment periods to determine the MTD. Participants will be given MTD of abiraterone for up to 12 cycles (28 day each) in Phase 2 of the study. Participants' safety will be monitored throughout the study.

Arms: arm 1: Abiraterone acetate 250 mg up to a maximum of 2000 mg capsules will be given orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants will receive MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg will be given orally (If participants have disease progression) daily up to 12 cycles.
Interventions: intervention 1: Abiraterone acetate intervention 2: Abiraterone acetate MTD intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD. intervention 2: Abiraterone acetate MTD orally for 12 cycles (28 day each). intervention 3: Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.

Protocol documents:
Clinical trial NCT00478608
Conditions: Renal Transplant
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-03-01; Completion date: 2008-11-01
Enrollment: 79 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.

Detailed description:

Interventions: intervention 1: Sirolimus (Rapamune®)
Intervention descriptions: intervention 1: (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.

Protocol documents:
Clinical trial NCT00478881
Conditions: Overactive Bladder Detrusor Overactivity
Sponsor: Bayer
Start date: 2007-08-01; Completion date: 2008-11-01
Enrollment: 397 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

Detailed description:

Arms: arm 1: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks arm 2: vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
Interventions: intervention 1: Vardenafil HCl (Levitra, BAY38-9456) intervention 2: Placebo
Intervention descriptions: intervention 1: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks intervention 2: vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Protocol documents:
Clinical trial NCT00479401
Conditions: Early Parkinson Disease (Early PD)
Sponsor: Boehringer Ingelheim
Start date: 2007-05-01; Completion date: 2008-11-01
Enrollment: 539 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole.

In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Pramipexol Extended Release intervention 2: Pramipexol Immediate Release intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00491530
Conditions: Mixed Dyslipidemia
Sponsor: Abbott
Start date: 2007-06-01; Completion date: 2008-11-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: ABT-335 intervention 2: rosuvastatin calcium intervention 3: simvastatin intervention 4: atorvastatin calcium
Intervention descriptions: intervention 1: Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study intervention 2: Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study intervention 3: Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study intervention 4: Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study

Protocol documents:
Clinical trial NCT00493246
Conditions: Pain Fever
Sponsor: Mallinckrodt
Start date: 2007-06-01; Completion date: 2008-11-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.

Detailed description:
A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever

Arms: arm 1: Intravenous Acetaminophen administered 15 milligrams/kilogram (mg/kg) every 8 hours (q8h) or every 6 hours (q6h) based age of subject arm 2: Intravenous Acetaminophen administered 12.5 milligrams/kilogram (mg/kg) every 6 hours (q6h) or every 4 hours (q4h)
Interventions: intervention 1: IV Acetaminophen intervention 2: IV Acetaminophen
Intervention descriptions: intervention 1: This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)

Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen intervention 2: This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)

Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen

Protocol documents:
Clinical trial NCT00502801
Conditions: Pneumonia Bacterial Pneumonia Ventilator-Associated Pneumonia Infections, Nosocomial
Keywords: Pneumonia Lung Infection Bacterial Infection Hospital-Acquired Infection Ventilator Infection Antibiotic Therapy
Sponsor: PriCara, Unit of Ortho-McNeil, Inc.
Start date: 2007-08-01; Completion date: 2008-11-01
Enrollment: 185 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.

Detailed description:
Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 to 14 days.

Arms: arm 1: 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
Interventions: intervention 1: doripenem
Intervention descriptions: intervention 1: 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

Protocol documents:
Clinical trial NCT00538681
Conditions: Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-09-01; Completion date: 2008-11-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:

* Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy
* Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part 2 are those with Nonsquamous Non-Small Cell Lung Cancer (NSCLC).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: enzastaurin intervention 2: pemetrexed intervention 3: cisplatin intervention 4: placebo
Intervention descriptions: intervention 1: 1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression intervention 2: 500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle intervention 3: 75 mg/m², IV, every 21 days, for each 21-day cycle intervention 4: po, QD

Protocol documents:
Clinical trial NCT00545298
Conditions: Venous Ulcers
Keywords: Nitric Oxide Venous Leg Ulcers
Sponsor: Nitric BioTherapeutics, Inc
Start date: 2007-10-01; Completion date: 2008-11-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers

Detailed description:
Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.

Arms: arm 1: Standard of care - dressings and sustained compression only arm 2: 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound arm 3: 200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
Interventions: intervention 1: Nitric Oxide - same dose 6 wks intervention 2: Nitric Oxide modified treatment
Intervention descriptions: intervention 1: 200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound intervention 2: 200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound

Protocol documents: