ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00368537
Conditions: Skin Diseases, Bacterial
Keywords: skin infection antibiotics
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2006-09-01; Completion date: 2008-09-01
Enrollment: 550 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

Detailed description:

Arms: arm 1: Arm 1: Tigecycline arm 2: Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
Interventions: intervention 1: Tigecycline intervention 2: ampicillin-sulbactam
Intervention descriptions: intervention 1: Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours) intervention 2: Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.

A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.

Protocol documents:
Clinical trial NCT00379795
Conditions: Choroidal Neovascularization, Age-related Macular Degeneration
Keywords: CNV Lucentis AMD Age-related macular degeneration RVO
Sponsor: Genentech, Inc.
Start date: 2005-04-01; Completion date: 2008-09-01
Enrollment: 853 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort enrolled patients with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). The results of the second cohort are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14 days of completion of the 24 month treatment phase of the previous study.

Detailed description:

Arms: arm 1: Ranibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment.
Interventions: intervention 1: Ranibizumab 0.5 mg
Intervention descriptions: intervention 1: Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)

Protocol documents:
Clinical trial NCT00426270
Conditions: Immune Thrombocytopenic Purpura
Sponsor: Octapharma
Start date: 2006-06-01; Completion date: 2008-09-01
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.

Detailed description:
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21.

The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.

Arms: arm 1: Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
Interventions: intervention 1: Octagam 10%
Intervention descriptions: intervention 1: Octagam 10% was supplied as a ready-to-use solution in glass bottles.

Protocol documents:
Clinical trial NCT00435019
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2007-02-01; Completion date: 2008-09-01
Enrollment: 348 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin

Detailed description:

Arms: arm 1: insulin detemir + insulin aspart arm 2: NPH insulin + insulin aspart
Interventions: intervention 1: insulin detemir intervention 2: insulin NPH intervention 3: insulin aspart
Intervention descriptions: intervention 1: s.c. injection, once or twice daily. intervention 2: s.c. injection, once or twice daily. intervention 3: s.c. injection, at main meals.

Protocol documents:
Clinical trial NCT00550043
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Sponsor: Incyte Corporation
Start date: 2007-10-01; Completion date: 2008-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis

Detailed description:

Arms: arm 1: INCB018424 15 mg twice daily (BID) or matching placebo arm 2: INCB018424 5 mg BID or matching placebo arm 3: INCB018424 25 mg BID or matching placebo arm 4: INCB018424 50 mg once daily (QD) or matching placebo arm 5: Matching placebo, oral
Interventions: intervention 1: INCB018424 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00570310
Conditions: Neuralgia, Postherpetic Diabetic Neuropathy Painful Small-Fiber Neuropathy Idiopathic Distal Sensory Polyneuropathy
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-12-01; Completion date: 2008-09-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.

Detailed description:

Arms: arm 1: Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period. arm 2: Patients in Group B will be treated with placebo.
Interventions: intervention 1: Comparator: pregabalin intervention 2: Comparator: Placebo (unspecified)
Intervention descriptions: intervention 1: pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks intervention 2: pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Protocol documents:
Clinical trial NCT00738530
Conditions: Renal Cell Cancer
Sponsor: Hoffmann-La Roche
Start date: 2004-06-01; Completion date: 2008-09-01
Enrollment: 649 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.

Detailed description:

Arms: arm 1: Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity. arm 2: Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
Interventions: intervention 1: Bevacizumab [Avastin] intervention 2: Interferon alfa 2a [Roferon] intervention 3: Placebo
Intervention descriptions: intervention 1: 10 mg/kg IV every 2 weeks intervention 2: 9 MIU SC 3 times/week intervention 3: IV every 2 weeks

Protocol documents:
Clinical trial NCT00042666
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Eli Lilly and Company
Start date: 2002-06-01; Completion date: 2008-09-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).

Detailed description:

Arms: arm 1: 500 milligrams (mg), oral, daily (QD), up to six (6) 28-day cycles
Interventions: intervention 1: LY317615
Intervention descriptions: intervention 1: 500 mg, oral, QD, up to six 28 day cycles

Protocol documents:
Clinical trial NCT00054717
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2003-01-01; Completion date: 2008-09-01
Enrollment: 630 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tipranavir intervention 2: Ritonavir(r) intervention 3: Comparator Protease Inhibitor (CPI)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00077974
Conditions: Carcinoma, Renal Cell
Sponsor: Pfizer
Start date: 2004-02-01; Completion date: 2008-09-01
Enrollment: 106 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SU011248
Intervention descriptions: intervention 1: 50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00078286
Conditions: Heart Failure, Congestive Chronic Heart Failure Depression
Keywords: Antidepressive Agents
Sponsor: Duke University
Start date: 2003-11-01; Completion date: 2008-09-01
Enrollment: 469 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.

Detailed description:
Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and CHF; studies that examine the way CHF is affected by depression treatments are needed.

Participants in this study will be randomly assigned to receive either sertraline or placebo for 12 weeks. Assessments will be made at Weeks 2, 4, 6, 8, 10, and 12. Participants who do not respond to their treatment will have their medication dose adjusted following assessment. Interviews and rating scales will be used to assess depressive symptoms, cognitive status, psychiatric comorbidity, daily and chronic stress, and social support. A follow-up visit will take place 6 months, 1 year, 2 years, and 3 years after study completion.

Arms: arm 1: Participants will take sertraline for 12 weeks arm 2: Participants will take placebo for 12 weeks
Interventions: intervention 1: Sertraline intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage ranging from 50 mg to 200 mg once a day intervention 2: Dosage ranging from 50 mg to 200 mg once a day

Protocol documents:
Clinical trial NCT00082173
Conditions: Tuberculosis
Sponsor: Johns Hopkins University
Start date: 2004-10-01; Completion date: 2008-09-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.

Detailed description:
Approximately one-third of the world's population is infected with Mycoplasma tuberculosis; 7 to 8 million new cases of active TB occur each year. TB is the second most common infectious cause of death worldwide. Appropriate treatment of persons with active TB is very important in limiting the transmission of M. tuberculosis and preventing TB-related mortality. Current therapy requires 6 months of a four-drug regimen of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and EMB.

The development of alternative regimens is a priority, and new classes of antituberculosis agents are needed to provide treatment options for patients with drug-resistant disease. This study will evaluate the effectiveness of replacing EMB with MOX in a multi-drug regimen in the initial phase of treatment of smear-positive pulmonary TB in patients with and without HIV infection.

Participants in this study will be randomly assigned to receive either a MOX-containing drug regimen or the standard EMB-containing drug regimen for 8 weeks. Participants will have study visits weekly during these 8 weeks. After 8 weeks, participants will discontinue MOX, EMB, and PZA and will continue taking INH and RFP for 4 months. Participants will have study visits at Months 4, 6, 12, and 18. Study visits will include a medical interview, physical exam, blood and urine tests, and sputum tests for TB.

Arms: arm 1: INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks arm 2: INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Interventions: intervention 1: Moxifloxacin
Intervention descriptions: intervention 1: 400mg daily for 8 weeks

Protocol documents:
Clinical trial NCT00082810
Conditions: Estrogen Receptor-positive Breast Cancer Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-03-01; Completion date: 2008-09-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally advanced or metastatic breast cancer that has progressed after previous first-line endocrine therapy. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with fulvestrant may kill tumor cells that did not respond to first-line therapy.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the efficacy of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant based on clinical benefit rate (CBR, a combination of complete response rate, partial response rate, and stable disease for more than 24 weeks) in postmenopausal women with hormone receptor-positive metastatic breast cancer who have progressive disease after first-line endocrine therapy.

SECONDARY OBJECTIVES:

I. To determine the median time to progression (TTP) and duration of response of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant in postmenopausal women with hormone receptor-positive metastatic breast cancer.

II. To determine the median overall survival of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant in postmenopausal women with hormone receptor- positive metastatic breast cancer who have progressive disease after first-line endocrine therapy.

III. To determine the toxicity profile of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant versus fulvestrant alone (from historical control) in postmenopausal women with hormone receptor positive metastatic breast cancer who have progressive disease after first-line endocrine therapy.

OUTLINE:

Patients receive fulvestrant intramuscularly on day 1 and oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity\*.

NOTE: \*Fulvestrant continues even if tipifarnib is held for toxicity.

Patients are followed every 3 months.

Arms: arm 1: Patients receive fulvestrant intramuscularly on day 1 and oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity\*.
Interventions: intervention 1: fulvestrant intervention 2: tipifarnib
Intervention descriptions: intervention 1: Given intramuscularly intervention 2: Given IV

Protocol documents:
Clinical trial NCT00083889
Conditions: Carcinoma, Renal Cell
Sponsor: Pfizer
Start date: 2004-08-01; Completion date: 2008-09-01
Enrollment: 750 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Interferon-alfa intervention 2: SU011248
Intervention descriptions: intervention 1: 3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity intervention 2: 50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00117585
Conditions: Hypotension, Orthostatic
Keywords: Aging Blood pressure Hypotension Orthostatic Rehabilitation
Sponsor: VA Office of Research and Development
Start date: 2005-11-01; Completion date: 2008-09-01
Enrollment: 341 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical course of OH during their inpatient stay.

Detailed description:
This study is a prospective, quasi-experiment conducted in two consecutive phases. During the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. During the intervention phase, patients enrolled who have OH will receive the intervention. Patients will be enrolled over two research phases and the investigators expect to evaluate 459 subjects. This research program will occur over a three-year period.

Methods:

During Phase I, baseline prevalence and natural history of OH will be determined by: enrolling consecutive appropriate subjects (able to stand, not end of life care) from a rehabilitation and nursing home unit and measuring OH 3 times weekly over their inpatient stay. In addition, chart review of diagnoses, medications, functional status, nutrition, and adverse events will be evaluated and correlated with clinical status. During Phase II, the investigators will implement a standardized, interdisciplinary (MD/RN/PT/Dietician) treatment plan for patients with OH. This will include chart review of diagnoses, medications, functional status, nutrition, adverse events, and correlation with clinical status. The goals of the interventions are to identify and treat the underlying causes of OH in rehabilitation patients. Based upon the comprehensive assessment, intervention participants will receive a standardized, interdisciplinary treatment regime.

Arms: arm 1: Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3)
Interventions: intervention 1: Treatment Phase 1 intervention 2: Treatment Phase 2 intervention 3: Treatment Phase 3
Intervention descriptions: intervention 1: * Patient Education
* Physical Therapy Exercises
* Increased Salt Intake
* Elevation of head of bed with 2-4 inch wedge
* Medication Review by MD, Pharma intervention 2: Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1.

* Fludrocortisone
* Salt tablet intervention 3: Subjects still experiencing orthostatic hypotension after receiving Treatment Phases 1 and 2 move on to Treatment Phase 3. Individualized treatment is based on subspecialty or orthostatic hypotension consultation at the medical center. Subjects are followed for the duration of their hospital stay, on average 4 weeks.

Protocol documents:
Clinical trial NCT00126438
Conditions: Heart Failure, Congestive
Keywords: Heart Failure nuclear cardiology sympathetic innervation 123I-mIBG
Sponsor: GE Healthcare
Start date: 2005-07-01; Completion date: 2008-09-01
Enrollment: 515 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcome in subjects with heart failure and in comparison to subjects without cardiovascular disease.

Detailed description:

Arms: arm 1: Single dose
Interventions: intervention 1: 123I-mIBG (meta-iodobenzylguanidine)
Intervention descriptions: intervention 1: Single Dose

Protocol documents: