ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00550459
Conditions: Hyponatremia
Keywords: Hyponatremia Cognitive Neurological Function Elderly
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2007-08-01; Completion date: 2009-03-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.

Detailed description:
Subjects will be randomized, with stratification by baseline sodium \<130 or ≥ 130 mEq/L\[mmol/L\] to receive either tolvaptan 15 mg tablet or matching placebo tablet at doses of 15, 30 or 60 mg for 21 days. During this period, fluid restrictions should be loosened or suspended, until the subject's response to therapy can be evaluated, typically over the first few days of therapy. Fluid restriction may be reinstituted at any time in subjects whose sodium fails to improve or worsens with study therapy. A forced-titration up to 60 mg of study drug by day 3 to 7 will be based on the subject's serum sodium Subjects entering the study with a serum sodium concentration less than 130 mEq/L\[mmol/L\] may be fluid restricted if necessary at the discretion of the Investigator. Subjects should be monitored closely during the first 24 hours of treatment for dosing titration. The total dosing duration will be up to 21 days (plus 3 day treatment window). Subjects will return to the clinic on Day 22 (+3 days) for assessments and will complete a follow-up visit on Day 28 (+2 days).

Arms: arm 1: Placebo tablet given once a day for 21 days arm 2: Tolvaptan 15 mg-60 mg tablet given once a day for 21 days.
Interventions: intervention 1: Tolvaptan intervention 2: Placebo
Intervention descriptions: intervention 1: 15-60 mg oral tablet given once a day for 21 days. intervention 2: Placebo tablet given once daily for 21 days

Protocol documents:
Clinical trial NCT00552175
Conditions: Diabetic Neuropathies
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2009-03-01
Enrollment: 339 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

Detailed description:

Arms: arm 1: duloxetine 60 milligram (mg) taken orally every day arm 2: Duloxetine 40 mg taken orally every day arm 3: placebo comparator taken orally every day
Interventions: intervention 1: Duloxetine hydrochloride - 40 mg intervention 2: placebo intervention 3: Duloxetine hydrochloride - 60 mg
Intervention descriptions: intervention 1: duloxetine 40 mg taken orally every day intervention 2: placebo taken orally every day intervention 3: duloxetine 60 mg taken orally every day

Protocol documents:
Clinical trial NCT00553475
Conditions: Diabetic Neuropathy, Painful
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-10-01; Completion date: 2009-03-01
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: placebo intervention 2: pregabalin intervention 3: pregabalin
Intervention descriptions: intervention 1: Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose) intervention 2: Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose) intervention 3: Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

Protocol documents:
Clinical trial NCT00569270
Conditions: COPD
Sponsor: Gelb, Arthur F., M.D.
Start date: 2006-10-01; Completion date: 2009-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized crossover double blinded study.

Detailed description:
Study completed with 29 patients studied. Data is being analyzed to evaluate trough and peak effect of 18 µg tiotropium vs placebo on FEV 1 (L)(forced expiratory capacity in one second), inspiratory capacity and functional residual volume. In addition, we will study the effect of 18 µg tiotropium vs placebo on metronome paced hyperventilation induced dynamic hyperinflation. We will also evaluate the effect of tiotropium induced increase in IC (inspiratory capacity) vs extent of emphysema as evaluated on high resolution thin section CT lung

Arms: arm 1: tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo arm 2: placebo 18ug tiotropium for 1 month
Interventions: intervention 1: Placebo
Intervention descriptions: intervention 1: Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation

Protocol documents:
Clinical trial NCT00575887
Conditions: Glioblastoma Astrocytoma Oligodendroglioma Brain Tumor, Recurrent
Keywords: Temozolomide Brain Tumor, Recurrent Chemotherapy
Sponsor: Marmara University
Start date: 2006-08-01; Completion date: 2009-03-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Temozolomide
Intervention descriptions: intervention 1: 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00586898
Conditions: Prostate Cancer Hormonal Cycling
Keywords: Prostate Cancer Hormones 01-085 ANTIFUNGAL ANTIBIOTICS ESTROGENS LUPRON TESTOSTERONE ZOLADEX
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2001-07-01; Completion date: 2009-03-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: GnRH intervention 2: Ketoconazole intervention 3: Bicalutamide intervention 4: Testosterone transdermal gel intervention 5: Estrogen transdermal patch
Intervention descriptions: intervention 1: leuprolide and goserelin are gonadotropin-releasing hormone analogues intervention 2: An imidazole antifungal agent. reduces adrenal and testicular androgen production in men intervention 3: A pure nonsteroidal antiandrogen intervention 4: an androgenic anabolic steroid intervention 5: Estradiol is the primary and most potent estrogen

Protocol documents:
Clinical trial NCT00592774
Conditions: Neuralgia
Keywords: Post-Herpetic Neuralgia PHN)
Sponsor: Eisai Inc.
Start date: 2008-01-01; Completion date: 2009-03-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: E2007 (perampanel) intervention 2: Placebo
Intervention descriptions: intervention 1: 2 mg titrated up to 8 mg maximum; taken once daily. intervention 2: 2 mg titrated up to 8 mg maximum; taken once daily.

Protocol documents:
Clinical trial NCT00595946
Conditions: Opioid-Induced Bowel Dysfunction
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2007-08-01; Completion date: 2009-03-01
Enrollment: 439 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction.

Detailed description:

Arms: arm 1: 0 mcg capsules twice daily (BID) arm 2: 24 mcg capsules twice daily (BID)
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 24 mcg capsules twice daily (BID) intervention 2: 0 mcg capsules twice daily (BID)

Protocol documents:
Clinical trial NCT00596934
Conditions: Fatty Liver Disease, Nonalcoholic
Keywords: Nonalcoholic fatty liver disease Insulin resistance Obesity Leptin therapy NASH
Sponsor: Elif Oral
Start date: 2006-02-01; Completion date: 2009-03-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the liver and development of scarring. This condition occurs more frequently in overweight and obese persons. It is often associated with resistance to the actions of insulin hormone. Fat cells secrete a hormone called leptin. Recently, we have learned that obese or overweight persons make too much leptin, which may contribute to insulin resistance. Paradoxically, patients who do not have any fat cells, also have insulin resistance. In these patients, insulin resistance is caused by the absence of leptin and leptin replacement significantly improves insulin resistance and fat deposition in the liver. In an earlier study, we determined the leptin levels in patients with NASH and how these levels are related to body fat levels as well as responsiveness to insulin. We saw that a subgroup of patients with NASH have relatively low levels of leptin in contrast to the amount of body fat they had. We now would like to see if restoring leptin levels to normal will improve the disease process in these patients. Our study patients will be male patients, aged between 18 and 65 (inclusive), who do not have any other cause for their liver disease. We have put some restrictions in body size such that a spectrum of patients from normal weight to obese range would be included. They will also demonstrate low leptin levels (levels similar to only 25% of normal population). We will use a genetically engineered form of leptin manufactured by Amylin Inc. given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters and body composition characteristics that we examined in our earlier study. We expect that patients with low blood leptin levels will show improvement in their liver disease and insulin resistance when their blood leptin levels are restored to normal.

Detailed description:

Arms: arm 1: Treatment group
Interventions: intervention 1: metreleptin
Intervention descriptions: intervention 1: 0.1 mg/kg/day once a day via subcutaneous injections

Protocol documents:
Clinical trial NCT00597428
Conditions: Opioid-Induced Bowel Dysfunction
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2007-08-01; Completion date: 2009-03-01
Enrollment: 437 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).

Detailed description:

Arms: arm 1: 0 mcg capsules twice daily (BID) arm 2: 24 mcg capsules twice daily (BID)
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 24 mcg capsules twice daily (BID) intervention 2: 0 mcg capsules twice daily (BID)

Protocol documents:
Clinical trial NCT00614380
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2008-01-01; Completion date: 2009-03-01
Enrollment: 976 participants; Allocation: ; Intervention model: 

Brief summary:
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

Detailed description:

Interventions: intervention 1: telmisartan/amlodipine 40/5 mg fixed combination intervention 2: telmisartan/amlodipine 80/5 mg fixed combination
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00623714
Conditions: Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-01-01; Completion date: 2009-03-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary goals of this study will be to implement innovative processing and detection assays to qualify induced sputum measurements of markers of allergen-induced airway inflammation. The results of this study are intended to form a platform to be used in the clinical development of novel asthma therapeutics.

Detailed description:

Arms: arm 1: study medication + Pbo arm 2: Pbo + study medication
Interventions: intervention 1: Comparator: fluticasone intervention 2: Placebo
Intervention descriptions: intervention 1: Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day. intervention 2: Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.

Protocol documents:
Clinical trial NCT00627016
Conditions: Gastroesophageal Reflux
Keywords: Non-Erosive Gastroesophageal Reflux Disease GERD heartburn sleep disturbance nocturnal Reflux
Sponsor: Takeda
Start date: 2008-03-01; Completion date: 2009-03-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.

Detailed description:
This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dexlansoprazole intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg capsule, orally, once daily for 4 weeks intervention 2: 1 capsule, orally, once daily for 4 weeks

Protocol documents:
Clinical trial NCT00630058
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Protease Inhibitor Telaprevir
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-04-01; Completion date: 2009-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MP-424(H), PEG-IFN-a-2b, RBV intervention 2: MP-424 (L), PEG-IFN-a-2b, RBV
Intervention descriptions: intervention 1: MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks intervention 2: MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Protocol documents:
Clinical trial NCT00632541
Conditions: Metastatic Breast Cancer
Sponsor: Hoosier Cancer Research Network
Start date: 2007-10-01; Completion date: 2009-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent activity in previously treated advanced breast cancer. This trial will test combined VEGF inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced breast cancer.

Detailed description:
OUTLINE: This is a multi-center study.

Sorafenib 200mg po daily Bevacizumab 5mg/kg every other week

1 Cycle = 4 weeks Imaging every third cycle

Acceptable toxicity and non-PD = Protocol therapy will continue Un-acceptable toxicity or PD = Protocol therapy will be discontinued

ECOG Performance Status 0-1

Life Expectancy: at least 12 weeks

Hematopoietic:

* Platelets \> 100 K/mm3
* Absolute neutrophil count (ANC) \> 1.5 K/mm3
* Hemoglobin \> 10 g/dL

Hepatic:

* Total Bilirubin \< 1.5 x ULN
* Aspartate aminotransferase (AST, SGOT) \< 2 x ULN (up to 5 x ULN in patients with known liver involvement)

Renal:

* Creatinine \< 1.5 x ULN
* No proteinuria as demonstrated by either Urine protein:creatinine (UPC) ratio \< 1.0 or Urine dipstick for proteinuria \< 2+

Cardiovascular:

* No known myocardial infarction, unstable angina, \> grade II New York Heart Association (NYHA) classification, congestive heart failure, uncontrolled hypertension defined as SBP \>150 or DBP \>100, \> grade II peripheral vascular disease or significant vascular disease (e.g. aortic aneurysm, aortic dissection) within 12 months prior to being registered for protocol therapy.
* No uncontrolled or clinically significant arrhythmia. NOTE: Controlled atrial fibrillation is allowed.
* LVEF ≥ LLN by MUGA or ECHO as obtained within 28 days prior to being registered for protocol therapy.

Pulmonary:

* No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within 28 days prior to being registered for protocol therapy.

Arms: arm 1: Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
Interventions: intervention 1: Sorafenib intervention 2: Bevacizumab intervention 3: Imaging
Intervention descriptions: intervention 1: Sorafenib 200mg po daily intervention 2: Bevacizumab 5mg/kg every other week

1 Cycle = 4 weeks intervention 3: Imaging every third cycle

Protocol documents:
Clinical trial NCT00642473
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-02-01; Completion date: 2009-03-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (\<) 3 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated at the same day as the start of erlotinib. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream). arm 2: Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated when participants develop rash. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
Interventions: intervention 1: Erlotinib intervention 2: Metronidazole Actavis intervention 3: Non-active Moisturizing Cream
Intervention descriptions: intervention 1: Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks. intervention 2: Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks. intervention 3: Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).

Protocol documents:
Clinical trial NCT00642603
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-05-01; Completion date: 2009-03-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: capecitabine [Xeloda] intervention 2: capecitabine [Xeloda] intervention 3: bevacizumab [Avastin] intervention 4: oxaliplatin intervention 5: irinotecan
Intervention descriptions: intervention 1: 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle intervention 2: 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle intervention 3: 5 mg/kg taken intravenously on Day 1 of each 2 week cycle intervention 4: 85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles intervention 5: 135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Protocol documents:
Clinical trial NCT00645671
Conditions: Ocular Inflammation
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-03-01; Completion date: 2009-03-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Detailed description:

Arms: arm 1: Loteprednol etabonate 0.5% ophthalmic ointment arm 2: Vehicle of loteprednol etabonate ointment
Interventions: intervention 1: 0.5% Loteprednol Etabonate Ophthalmic Ointment intervention 2: Vehicle of Loteprednol Etabonate Ophthalmic Ointment
Intervention descriptions: intervention 1: 1/2 inch ribbon four times a day for 14 days intervention 2: 1/2 inch ribbon four times a day for 14 days

Protocol documents: