ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00358735
Conditions: Deep Vein Thrombosis of Lower Limb Pulmonary Embolism (PE) Bleeding
Keywords: SAFE CECT SFT ActiveCare ActiveCare+SFT Deep Vein Thrombosis prevention Total Hip Replacement Total Hip Arthroplasty Low Molecular Weight Heparin MCS
Sponsor: Medical Compression Systems
Start date: 2006-06-01; Completion date: 2008-12-01
Enrollment: 411 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.

Detailed description:
Patients undergoing total hip arthroplasty surgery are at particular risk for Thromboembolic disease. To date two prophylactic modalities are being used: mechanical (intermittent pneumatic compression \[IPC\]) and pharmacological (anticoagulant). Both are effective; however each carries its own advantages and disadvantages.

The purpose of this study is to compare in total hip arthroplasty (THA) patients the safety and effectiveness of the mobile ActiveCare CECT based prophylaxis protocol and compare it with LMWH standard of care protocol for this patient population.

The protocol is based upon the CECT system as the primary DVT prophylaxis method (with or without the addition of low dose baby aspirin \[81 mg\]).

Arms: arm 1: The ActiveCare CECT device is a mobile compression device used to prevent venous thromboembolic events, used after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. arm 2: Enoxaparin (LMWH) will be used, following a protocol that is considered a standard of care for this patient population. 40mg QD for the remainder of the 10 days.
Interventions: intervention 1: ActiveCare CECT device intervention 2: Enoxaparin
Intervention descriptions: intervention 1: Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the remainder of the 10-12 days. Patients will wear the device to the duplex ultrasound when it will be discontinued by nurse. intervention 2: Patients will be treated with Enoxaparin (Lovenox) for a total of 10 days beginning with 30mg BID starting 12-24 hours after surgery and continued until hospital discharge. Post discharge prophylaxis will be Enoxaparin 40mg QD for the remainder of the 10 days.

Protocol documents:
Clinical trial NCT00361218
Conditions: Major Depressive Disorder
Keywords: depression biology
Sponsor: Massachusetts General Hospital
Start date: 2005-10-01; Completion date: 2008-12-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).

Detailed description:
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain.

It often takes several weeks to find out if an antidepressant medication is going to work for someone. This research study aims to identify tests that are able to predict if a medication will work, even before a person starts to feel better. The first test is a measurement of the blood protein Brain-Derived Neurotrophic Factor (BDNF), which is involved with brain cell growth. The second test is a Quantitative Electroencephalogram (QEEG), which measures brain activity.

The study lasts for 8 weeks and involves 5 total visits to the clinic. Throughout the study, all subjects will receive either escitalopram (Lexapro) or citalopram (Celexa) on the basis of the study doctor's clinical judgment. The dose of the medications can be increased at any point in time if the study doctor thinks it is appropriate. After the first screen visit (which lasts about 3 hours), each subsequent half-hour visit will involve a 2-tablespoon blood draw to measure BDNF levels, as well as a QEEG in which small, painless electrodes are stuck to the subject's forehead and electrical activity of the brain is measured. At the end of the 8 weeks, subjects are offered 3 months of free follow-up care, including medications.

Arms: arm 1: citalopram or escitalopram
Interventions: intervention 1: open-label selective serotonin reuptake inhibitor (SSRI)
Intervention descriptions: intervention 1: Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.

Protocol documents:
Clinical trial NCT00367601
Conditions: Lung Cancer
Sponsor: Nasser Hanna, M.D.
Start date: 2006-08-01; Completion date: 2008-12-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore, because there is little to no overlap in toxicity profile between the two agents, the combination is expected to be well tolerated and may provide even greater benefit for patients who are unable to receive cytotoxic therapy.

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

* Bevacizumab 15 mg/kg IV on day 1
* Erlotinib 150 mg po qd days 1-21
* Disease Assessment during even numbered cycles

If no progressive disease observed, continue (combination or single agent- see below) until unacceptable toxicity or progressive disease.

If progressive disease observed, treatment will be discontinued.

* Cycles will be repeated every 21 days up to a total of 6 cycles.
* Patients with non-progression after 6 cycles may stay on therapy (single agent erlotinib or the combination) until progressive disease or intolerable toxicity (at the physician discretion).
* Patients who require discontinuation of bevacizumab may receive at investigator's discretion erlotinib alone on study until progression.
* Patients who require discontinuation of erlotinib may receive at investigator's discretion bevacizumab alone until progression.

ECOG Performance Status 2

Hematopoietic:

* Absolute neutrophil count (ANC) \> 1,000 mm3
* Platelet count \> 100,000 mm3
* Hemoglobin \> 8 g/dl

Hepatic:

* Bilirubin \< 2 X upper limit of normal.
* Aspartate aminotransferase (AST, SGOT) \< 2.5 X upper limit of normal or 5 X if liver involvement.

Renal:

* Urine protein:creatinine ratio 1.0 at screening

Cardiovascular:

* Blood pressure of \< 150/100 mmHg.
* No history of unstable angina.
* No history of New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* No history of myocardial infarction within 6 months prior to registration for protocol therapy.
* No history of stroke within 6 months prior to registration for protocol therapy.
* No clinically significant peripheral vascular disease.

Arms: arm 1: Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Interventions: intervention 1: Erlotinib intervention 2: Bevacizumab
Intervention descriptions: intervention 1: Erlotinib 150 mg qd days 1-21 intervention 2: Bevacizumab 15 mg/kg IV, day 1

Protocol documents:
Clinical trial NCT00367744
Conditions: HIV Infections
Keywords: mitochondria HIV lipoatrophy
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2006-07-01; Completion date: 2008-12-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).

Detailed description:
This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

Arms: arm 1: Rosiglitazone active 4 mg BID arm 2: Matching Placebo BID
Interventions: intervention 1: Rosiglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: Rosiglitazone 4mg BID intervention 2: Placebo for rosiglitazone

Protocol documents:
Clinical trial NCT00369161
Conditions: Renal Transplantation
Sponsor: Novartis
Start date: 2006-06-01; Completion date: 2008-12-01
Enrollment: 228 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.

Detailed description:

Arms: arm 1: The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice. arm 2: The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
Interventions: intervention 1: Everolimus (RAD001) intervention 2: Tacrolimus intervention 3: Basiliximab intervention 4: Corticosteroids
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00369278
Conditions: Renal Transplantation
Keywords: Renal transplantation, mycophenolate
Sponsor: Novartis Pharmaceuticals
Start date: 2006-06-01; Completion date: 2008-12-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg\*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).

Detailed description:

Arms: arm 1: Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 180 days. arm 2: Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 6 months.
Interventions: intervention 1: Enteric-coated mycophenolate sodium (EC-MPS)
Intervention descriptions: intervention 1: Tablets for oral administration

Protocol documents:
Clinical trial NCT00371137
Conditions: Fibromyalgia
Keywords: FMS Fibro pain Body pain tenderness joint pain stiffness muscular pain
Sponsor: Jazz Pharmaceuticals
Start date: 2006-08-01; Completion date: 2008-12-01
Enrollment: 548 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

Detailed description:
The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined, followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Xyrem® intervention 2: Placebo
Intervention descriptions: intervention 1: two doses intervention 2: Oral Solution

Protocol documents:
Clinical trial NCT00396032
Conditions: Dysfunctional Hemodialysis Catheters
Keywords: HD Hemodialysis Catheter clearance TNKase Renal Insufficiency
Sponsor: Genentech, Inc.
Start date: 2006-10-01; Completion date: 2008-12-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: tenecteplase
Intervention descriptions: intervention 1: For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase intervention 2: For the initial treatment, 2 mL of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase

Protocol documents:
Clinical trial NCT00397020
Conditions: Bipolar Disorder
Keywords: quetiapine divalproex
Sponsor: University of California, San Diego
Start date: 2006-12-01; Completion date: 2008-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested:

Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in the symptomatic control of mania or mixed mania

Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements in symptoms of mania sooner than quetiapine

Hypothesis 3: divalproex extended-release may produce significantly less sedation

Detailed description:
This will be a rater-blinded, head-to-head comparison (no placebo) of divalproex ER and quetiapine in patients with symptoms of an active manic or mixed mania (symptoms of mania and depression). Forty subjects are expected to be enrolled. After screening for eligibility, eligible subjects will be randomized while hospitalized in a 1:1 ratio into 2 treatment groups: divalproex ER or quetiapine. Depakote® ER will be given orally at 30 mg/kg day initially taken at night and rounded up to nearest 500 mg dose with adjustments made through the trial as needed to obtain serum valproic acid levels of 85-125 mcg/ml. Quetiapine will be given orally at an initial dose of 200mg/day on Day 1, and titrate up to 800 mg/day. The duration of the study will be 21 days from baseline and the total number of visits including screening is five. Patients will be released from the hospital once stable and visits for the study will then take place on an outpatient basis.

Arms: arm 1: Divalproex ER arm 2: quetiapine fumarate
Interventions: intervention 1: divalproex ER intervention 2: quetiapine
Intervention descriptions: intervention 1: Dose: 30mg per kg, rounded to nearest 500mg, dosed PO QHS. Adjustments made through trial to obtain serum valproic acid levels of 85-125 mcg/ml intervention 2: Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.

Protocol documents:
Clinical trial NCT00398411
Conditions: Hodgkin Disease Non-Hodgkin Lymphoma Multiple Myeloma Bacteremia
Keywords: prophylaxis bacteremia moxifloxacin stem cell transplantation Hodgkin disease non-Hodgkin lymphoma multiple myeloma solid tumor autologous stem cell transplantation
Sponsor: University of Cologne
Start date: 2006-10-01; Completion date: 2008-12-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.

Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.

Detailed description:
Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.

Arms: arm 1: moxifloxacin 400 mg tablets once daily arm 2: identical appearing placebo
Interventions: intervention 1: moxifloxacin intervention 2: placebo
Intervention descriptions: intervention 1: 400 mg p.o. per day intervention 2: one tablet per day p.o.

Protocol documents:
Clinical trial NCT00404547
Conditions: Asthma
Keywords: Asthma Alvesco® Ciclesonide
Sponsor: AstraZeneca
Start date: 2006-11-01; Completion date: 2008-12-01
Enrollment: 1121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.

Detailed description:

Arms: arm 1: Alvesco 320mcg / Alvesco 640mcg arm 2: None
Interventions: intervention 1: Ciclesonide intervention 2: Usual Care Inhaled Glucocorticosteroids
Intervention descriptions: intervention 1: Asthma Care with Alvesco intervention 2: Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment

Protocol documents:
Clinical trial NCT00404820
Conditions: Osteoporosis
Keywords: osteoporosis bisphosphonate biomarker zoledronic acid alendronate postmenopausal
Sponsor: Novartis
Start date: 2006-10-01; Completion date: 2008-12-01
Enrollment: 604 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.

Detailed description:

Arms: arm 1: Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily. arm 2: Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
Interventions: intervention 1: Zoledronic acid 5 mg solution intervention 2: Alendronate 70 mg tablets intervention 3: Calcium/Vitamin D
Intervention descriptions: intervention 1: Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid. intervention 2: Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. intervention 3: Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.

Protocol documents: