ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00128492
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis Pseudomonas aeruginosa
Sponsor: Gilead Sciences
Start date: 2005-08-01; Completion date: 2009-01-01
Enrollment: 274 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Detailed description:
People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacteria. The antibiotics may be given orally, intravenously, or inhaled as a mist. The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.

A course of AZLI treatment in this study comprised 28 days, followed by a 28-day period off treatment. Participants could receive up to 9 courses of AZLI, with a total time on study of up to 18 months. Safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.

Interventions: intervention 1: AZLI 75 mg two times a day (BID)/ three times a day (TID)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00129220
Conditions: Bipolar Disorder
Keywords: Manic or mixed episode associated with bipolar I disorder
Sponsor: Eli Lilly and Company
Start date: 2005-07-01; Completion date: 2009-01-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.

Detailed description:

Arms: arm 1: olanzapine: 5 to 20 mg per day for 6 weeks arm 2: haloperidol: 2.5 to 10 mg per day for 6 weeks arm 3: placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
Interventions: intervention 1: olanzapine intervention 2: haloperidol intervention 3: placebo
Intervention descriptions: intervention 1: 5-20 mg, oral, once daily (evening), for 6 weeks intervention 2: 2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks. intervention 3: placebo, oral tablets, twice daily (morning and evening), for 3 weeks

Protocol documents:
Clinical trial NCT00129961
Conditions: Skin Neoplasms Kidney Transplantation
Keywords: Kidney Transplant Skin Cancer
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2005-08-01; Completion date: 2009-01-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.

Detailed description:

Arms: arm 1: Conversion to a sirolimus-based regimen arm 2: Continuation of a CNI-based regimen
Interventions: intervention 1: sirolimus intervention 2: cyclosporine or tacrolimus
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00130039
Conditions: Cerebral Infarction Atherosclerosis
Keywords: Infarction, Cerebral cilostazol stenosis atherosclerosis clopidogrel
Sponsor: Asan Medical Center
Start date: 2005-08-01; Completion date: 2009-01-01
Enrollment: 457 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery).

They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally.

The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on magnetic resonance angiogram (MRA).

Detailed description:
\[Goal\] To Reveal the Effect and Safety of Cilostazol Compared with Clopidogrel on the Prevention of the Progression of Symptomatic Intracranial Arterial Stenosis.

\[Trial Design\] Double-Blind, Active-Controlled, Randomized, Multicenter Trial

\[Participants\] Acute ischemic stroke patients with symptomatic intracranial arterial stenosis

\[Methods\]

* Double-Blind, Active-Controlled, Randomized, Multicenter Trial
* Investigational product (Double Dummy Method):

Cilostazol 200mg (100mg twice per day) versus clopidogrel 75mg

* Concomitant medication: Aspirin 100 (75-150) mg per day
* Medication Duration: 7 months

\[Outcome Variables\]

Primary Outcome Variable:

* Progression rate of symptomatic intracranial arterial stenosis

Secondary outcome variables:

* The occurrence of new MRI (magnetic resonance image) lesion on follow-up MRI
* Stroke events
* Overall cardiovascular events: stroke, acute coronary syndrome, vascular death
* Ipsilateral ischemic stroke rate
* Fatal or major bleeding complications

Arms: arm 1: cilostazol 100mg bid plus placebo of clopidogrel arm 2: clopidogrel 75mg qd and matching placebo of cilostazol
Interventions: intervention 1: clopidogrel intervention 2: Cilostazol
Intervention descriptions: intervention 1: Clopidogrel 75mg once a day plus placebo of cilostazol twice a day intervention 2: Cilostazol 100mg twice a day plus placebo of clopidogrel once a day

Protocol documents:
Clinical trial NCT00149227
Conditions: Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke
Keywords: High risk hypertension Ischemic heart disease Angiotensin receptor blockers Cardiovascular mortality- morbidity KYOTO HEART Study
Sponsor: Kyoto Prefectural University of Medicine
Start date: 2004-01-01; Completion date: 2009-01-01
Enrollment: 3031 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.

Detailed description:
Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are superior for prevention of cardiovascular events, previous data are not enough for the patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it has not been clarified whether the evidence in Western countries could be unqualifiedly applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients with hypertension in terms of the morbidity and mortality.

Arms: arm 1: 'Non-ARB' was defined as Conventional anti-hypertensive treatment except for ARB and ACEIs arm 2: Valsartan add-on treatment
Interventions: intervention 1: Valsartan intervention 2: Non-ARB
Intervention descriptions: intervention 1: Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary. intervention 2: 'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs

Protocol documents:
Clinical trial NCT00157248
Conditions: Atrial Fibrillation Stroke
Sponsor: Boehringer Ingelheim
Start date: 2003-12-01; Completion date: 2009-01-01
Enrollment: 361 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).

Detailed description:

Arms: arm 1: dosage used at study start arm 2: dosage used at study start arm 3: dosage used at study start arm 4: dosage used at study start
Interventions: intervention 1: dabigatran etexilate intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate intervention 4: dabigatran etexilate
Intervention descriptions: intervention 1: dosage used at study start intervention 2: dosage used at study start intervention 3: dosage used at study start intervention 4: dosage used at study start

Protocol documents:
Clinical trial NCT00166114
Conditions: Major Depressive Disorder
Keywords: platelet function childhood abuse depression antidepressants immune function stress response
Sponsor: Emory University
Start date: 2002-02-01; Completion date: 2009-01-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Escitalopram intervention 2: Desipramine
Intervention descriptions: intervention 1: 10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention intervention 2: 25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention

Protocol documents:
Clinical trial NCT00186186
Conditions: Depression, Bipolar
Sponsor: Stanford University
Start date: 2004-01-01; Completion date: 2009-01-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRI/MRS brain imaging techniques.

Detailed description:
Mood disorders are important public health problems. Bipolar disorder is a major psychiatric disorder characterized by mood cycles alternating between mania and depression and affects approximately 1% of the population. Most patients are treated beginning in the early twenties and then embark on a course marked by multiple recurrences, hospitalizations, and encounters with legal authorities. These disorders inflict substantial morbidity which yields important deficits in occupational and interpersonal function. The risk of suicide in mood disorders may be as high as 10%.

Although the outlook for recovery from acute manic or depressive episodes is generally excellent, the long-term prognosis of the disorder varies tremendously across the patient population. The introduction of lithium, anticonvulsants and atypical antipsychotics significantly changes the outlook for bipolar disorder, with some individuals on chronic treatment attaining complete remission and indefinite prophylaxis against mood episodes. However, such optimum outcomes may be limited to as few as one-third to one-half of all treated patients. The remaining experiences various combinations of breakthrough mood episodes, including chronic mood instability, persistent depression, and rapid cycling.

Very little research has been conducted with bipolar disorder, and no medications have an FDA indication to treat bipolar depression. Previous studies suggest that Depakote is promising in the treatment of mixed and depressed episodes of bipolar disorder. This study utilizes the extended release formulation of divalproex sodium, with demonstrated increased tolerability.

We propose investigating safety, tolerability and efficacy of Depakote ER monotherapy in Bipolar I, II or NOS depression, and monitoring associated changes in brain GABA levels. In addition, we intend to evaluate and assess the differences between brain metabolic rate and GABA levels in bipolar disorder patients and healthy volunteers.

Arms: arm 1: Depakote ER up to 1500 mg/day
Interventions: intervention 1: Depakote ER
Intervention descriptions: intervention 1: Depakote ER

Protocol documents:
Clinical trial NCT00189436
Conditions: Asthma
Keywords: Asthma
Sponsor: Deborah Gentile
Start date: 2003-03-01; Completion date: 2009-01-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.

Detailed description:
Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.

Arms: arm 1: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks arm 2: Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
Interventions: intervention 1: Nebulized Budesonide intervention 2: Usual care (albuterol with or without oral steroid)
Intervention descriptions: intervention 1: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks intervention 2: Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)

Protocol documents:
Clinical trial NCT00193128
Conditions: Esophagus Cancer
Keywords: Esophagus Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2004-04-01; Completion date: 2009-01-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.

Detailed description:
Upon determination of eligibility, patients will be receive:

Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy

If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy

Arms: arm 1: Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).

Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved. arm 2: Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).

Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.
Interventions: intervention 1: Oxaliplatin intervention 2: Docetaxel intervention 3: Capecitabine intervention 4: Radiation therapy
Intervention descriptions: intervention 1: 40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts intervention 2: 20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts intervention 3: In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. intervention 4: In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).

Protocol documents:
Clinical trial NCT00193180
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2005-05-01; Completion date: 2009-01-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

Detailed description:
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily

Arms: arm 1: All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
Interventions: intervention 1: Imatinib intervention 2: Docetaxel
Intervention descriptions: intervention 1: Imatinib intervention 2: Docetaxel

Protocol documents:
Clinical trial NCT00193609
Conditions: Neoplasms, Unknown Primary
Keywords: Neoplasms, Unknown Primary
Sponsor: SCRI Development Innovations, LLC
Start date: 2004-09-01; Completion date: 2009-01-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this phase II trial, we will evaluate the feasibility and efficacy of the oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy regimen for the treatment of carcinoma of unknown primary site. Patients who are relapsed after a previous response to treatment will be eligible, as well as those who were refractory to first-line therapy.

Detailed description:
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 PO BID was administered on days 1-14 of each cycle.

Arms: arm 1: All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
Interventions: intervention 1: Oxaliplatin intervention 2: Capecitabine
Intervention descriptions: intervention 1: 130 mg/m2 IV day 1 of 21 day cycle intervention 2: 1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle

Protocol documents:
Clinical trial NCT00212355
Conditions: Wilson's Disease
Sponsor: Nobelpharma
Start date: 2005-03-01; Completion date: 2009-01-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this long-term study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.

Detailed description:
Wilson disease is an autosomal recessive disorder with copper metabolism. In Japan, the standard treatment is the use of copper chelating agents, such as D-penicillamine and trientine. In this study, we investigate efficacy on zinc acetate in Japanese patients with Wilson disease.

Arms: arm 1: zinc acetate
Interventions: intervention 1: NPC-02
Intervention descriptions: intervention 1: zinc acetate

Protocol documents:
Clinical trial NCT00263575
Conditions: Pain Cancer
Keywords: EN3267 Breakthrough Pain Safety Study Fentanyl Tablets
Sponsor: Kyowa Kirin Co., Ltd.
Start date: 2005-12-01; Completion date: 2009-01-01
Enrollment: 139 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.

Detailed description:
This was a Phase 3 non-randomized, open-label, multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients. The study was conducted in 2 parts:

1. A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and
2. A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Arms: arm 1: None
Interventions: intervention 1: EN3267
Intervention descriptions: intervention 1: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

Protocol documents:
Clinical trial NCT00272311
Conditions: Cardiovascular Diseases Metabolic Syndrome X Atherosclerosis
Keywords: Primary prevention Cardiovascular diseases Aspirin Metabolic Syndrome X Atherosclerosis
Sponsor: Florida Atlantic University
Start date: 2006-10-01; Completion date: 2009-01-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients at risk of a first heart attack.

Detailed description:
Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack. Aspirin also prevents a first heart attack.

Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.

Arms: arm 1: 81 mg Aspirin arm 2: 162 mg Aspirin arm 3: 325 mg Aspirin arm 4: 650 mg Aspirin arm 5: 1300 mg Aspirin
Interventions: intervention 1: Aspirin
Intervention descriptions: intervention 1: Dosage

Protocol documents: