ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00335153
Conditions: Advanced Parkinson's Disease
Keywords: severe motor fluctuations levodopa levodopa/carbidopa intestinal gel efficacy dyskinesia Parkinson's Disease carbidopa DUOPA
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2008-01-01; Completion date: 2012-06-01
Enrollment: 354 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

Detailed description:
The study was composed of a screening period followed by 3 sequential on-treatment periods, as follows:

* Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (NJ) tube placement.
* NJ Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of NJ tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via NJ tube and infusion pump (participant was hospitalized for NJ tube placement but hospitalization was not required for entire duration of LCIG treatment optimization).
* PEG-J Period (2 to 14 days): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.
* Post PEG-J Long-Term Treatment Period (Day 28 to Day 378): LCIG administration via a permanent PEG-J tube and infusion pump, with dosage adjusted according to clinical condition.

Arms: arm 1: All participants were to receive LCIG, via the NJ tube during the nasojejunal (NJ) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Interventions: intervention 1: Levodopa-carbidopa intestinal gel intervention 2: CADD-Legacy® 1400 ambulatory infusion pump intervention 3: PEG tube intervention 4: J-tube
Intervention descriptions: intervention 1: Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour). intervention 2: None intervention 3: percutaneous endoscopic gastrostomy tube intervention 4: jejunal tube

Protocol documents:
Clinical trial NCT00349349
Conditions: Leukaemia, Lymphocytic, Chronic
Sponsor: GlaxoSmithKline
Start date: 2006-06-01; Completion date: 2012-06-01
Enrollment: 223 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.

Detailed description:

Arms: arm 1: Anti-CD20 antibody therapy
Interventions: intervention 1: ofatumumab
Intervention descriptions: intervention 1: Intravenous infusion

Protocol documents:
Clinical trial NCT00909779
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease (COPD) respiratory long-acting beta agonist (LABA)
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2009-06-01; Completion date: 2012-06-01
Enrollment: 841 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.

Detailed description:
This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group, outpatient, safety study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. The administration of arformoterol in subjects with moderate to severe COPD will not result in a meaningfully greater incidence of respiratory death and COPD exacerbation -related hospitalizations compared to placebo (nebulized saline and non-long-acting beta2-agonist \[LABA\] COPD standard of care treatments). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. arm 2: Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
Interventions: intervention 1: Arformoterol intervention 2: Placebo
Intervention descriptions: intervention 1: Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year intervention 2: Placebo inhalation solution, twice daily (BID) for a duration of one year.

Protocol documents:
Clinical trial NCT00948766
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease dementia Alzheimer's type
Sponsor: Novartis
Start date: 2009-07-01; Completion date: 2012-06-01
Enrollment: 716 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm\^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm\^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks.

Detailed description:

Arms: arm 1: In the core study, patients were titrated to the rivastigmine 13.3 mg/24 h dose in 2 steps. For Weeks 1-4, patients received rivastigmine 4.6 mg/24 h. For Weeks 5-8, patients received rivastigmine 9.5 mg/24 h and placebo. For Weeks 9-24, patients received rivastigmine 13.3 mg/24 h and placebo. In the extension study, all patients were switched to rivastigmine 9.5 mg/24 h for a 4-week titration period and were then titrated up to 13.3 mg/24 h for a further 20 weeks of treatment. arm 2: In the core study, patients received rivastigmine 4.6 mg/24 h daily. For Weeks 1-4, patients received rivastigmine 4.6 mg/24 h. For Weeks 5-24, patients received rivastigmine 4.6 mg/24 h and placebo. No patients received this treatment in the extension study.
Interventions: intervention 1: Rivastigmine 4.6 mg/24 h (5 cm^2) intervention 2: Rivastigmine 9.5 mg/24 h (10 cm^2) intervention 3: Rivastigmine 13.3 mg/24 h (15 cm^2) intervention 4: Placebo
Intervention descriptions: intervention 1: Rivastigmine was supplied in a 5 cm\^2 patch which released 4.6 mg/24 h. Patches were changed daily. intervention 2: Rivastigmine was supplied in a 10 cm\^2 patch which released 9.5 mg/24 h. Patches were changed daily. intervention 3: Rivastigmine was supplied in a 15 cm\^2 patch which released 13.3 mg/24 h. Patches were changed daily. intervention 4: Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.

Protocol documents:
Clinical trial NCT01591382
Conditions: Postoperative Pain
Keywords: Ketamine Postoperative pain Opioid dependent patients Acute pain control
Sponsor: Brigham and Women's Hospital
Start date: 2008-09-01; Completion date: 2012-06-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.

Detailed description:

Arms: arm 1: Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery. arm 2: Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Interventions: intervention 1: Ketamine intervention 2: Placebo intervention 3: Hydromorphone PCA
Intervention descriptions: intervention 1: Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively. intervention 2: Patients who received ketamine-matching placebo were given saline infusions intervention 3: Intravenous hydromorphone PCA

Protocol documents:
Clinical trial NCT00057941
Conditions: Estrogen Receptor-positive Breast Cancer Progesterone Receptor-positive Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-09-01; Completion date: 2012-06-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well giving gefitinib together with anastrozole works compared to giving gefitinib together with fulvestrant in treating postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate the antitumor activity of anastrozole given in combination with the EGFR tyrosine kinase inhibitor ZD1839, and of fulvestrant given in combination with the EGFR tyrosine kinase inhibitor ZD1839.

II. Evaluate the safety of anastrozole given in combination with ZD1839 and fulvestrant given in combination with ZD1839.

III. Evaluate the interaction of biological characteristics that predict for response of breast cancer to treatment with anastrozole and ZD1839 and with fulvestrant and ZD1839.

OUTLINE: This is a randomized, open-label study. Patients are stratified according to prior hormonal therapy (yes vs. no) and dominant site of disease (soft tissue/lymph nodes vs. bone vs. visceral). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.

Arm II: Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.

Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Arms: arm 1: Patients receive oral anastrozole and oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: anastrozole intervention 2: gefitinib intervention 3: fulvestrant intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Given intramuscularly intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT00183092
Conditions: Creutzfeldt-Jakob Disease
Keywords: dementia spongiform encephalopathy nervous system disorder acridine prion neuropharmacologic agent
Sponsor: University of California, San Francisco
Start date: 2005-04-01; Completion date: 2012-06-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical trial is to determine the effectiveness of the medication quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).

Detailed description:
Creutzfeldt-Jakob disease (CJD)is a rapidly progressive, invariably fatal and untreatable neurodegenerative disease with a mean duration of about eight months. Beyond the debilitating cognitive and motor deficits that accompany CJD, the difficulty in treating behavioral and mood disturbances and the rapidity of its course compound its tragedy. Recent results from experiments show that, at physiological concentrations, the anti-malarial drug quinacrine permanently clears abnormal prion proteins from cell culture. The demonstrated efficacy of quinacrine in cell culture, its relative safety and well known side-effects in the clinical setting, and the universal fatality of CJD justify quinacrine as an immediate candidate for the treatment of CJD.

The purpose of this clinical trial is to determine the efficacy of the medication quinacrine on survival in sporadic CJD (sCJD). This will be accomplished by bringing approximately 60 patients with probable or definite sCJD over approximately three years to UCSF for evaluation and initiation of a randomized, double-blinded, placebo-controlled (delayed treatment start) treatment study of quinacrine. Each patient will have a 50:50 chance of being placed on quinacrine or placebo upon study enrollment; however, all patients will be offered quinacrine after two months. Prior to study enrollment, patients will have a comprehensive clinical assessment to confirm the diagnosis of sCJD. Participants will come to UCSF for initial evaluation, potential study enrollment and, if possible, return to UCSF for follow-up at two and twelve months. Patients will receive telephone follow-up (every 2 weeks for the first two months and monthly thereafter) and local blood and testing to monitor for possible medication toxicity.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Quinacrine intervention 2: Placebo
Intervention descriptions: intervention 1: 100mg by mouth three times a day intervention 2: 100mg by mouth three times a day

Protocol documents:
Clinical trial NCT00194012
Conditions: Bipolar Disorder
Keywords: bipolar disorder
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2004-08-01; Completion date: 2012-06-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder.

Detailed description:
This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks.

This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to aripiprazole (APZ); 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.

Arms: arm 1: Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response. arm 2: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Addressed in arm description. intervention 2: Addressed in arm description.

Protocol documents:
Clinical trial NCT00319956
Conditions: Bronchopulmonary Dysplasia
Keywords: premature infant respiratory distress syndrome mechanical ventilation
Sponsor: Hubert Ballard
Start date: 2004-09-01; Completion date: 2012-06-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.

The purpose of this study is to determine if Azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.

Detailed description:
The survival of preterm infants has increased dramatically and has been associated with an increase in BPD. The incidence of BPD among extremely low birthweight infants ranges from 45% to 90%. Development of BPD is associated with both antenatal (maternal chorioamnionitis often due to Ureaplasma is related to BPD) and postnatal complications (oxygen toxicity, barotrauma, late onset infections). These insults appear to lead to an inflammatory response with resultant arrest of normal alveolar and vascular development. Multiple human studies support the role of inflammation in the development of BPD.

Evaluating a medication that could decrease the inflammation in BPD, with minimal side effects, could significantly improve the morbidities of prematurity and the financial burden incurred by parents. Macrolide antibiotics (erythromycin and azithromycin) have been shown to have anti-inflammatory properties that are independent of their antimicrobial properties.

Azithromycin has the potential to decrease the severity of ventilator-induced pulmonary inflammation that is commonly seen in BPD.

Arms: arm 1: Group receives azithromycin arm 2: Group receives placebo
Interventions: intervention 1: Azithromycin intervention 2: Placebo
Intervention descriptions: intervention 1: Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days. intervention 2: vehicle dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.

Protocol documents:
Clinical trial NCT00374140
Conditions: Small Cell Lung Cancer
Keywords: small cell lung
Sponsor: Ahmad Tarhini
Start date: 2006-10-01; Completion date: 2012-06-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be administered orally at a dose of 10 mg daily.

Detailed description:
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. Patients may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no prior therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10 mg daily. A cycle will be defined as 3 weeks of study drug administration, and patients will have tumor measurements every 2 cycles. Study participation will continue until disease progression or intolerable toxicities. In addition, in patients who consent, archival tumor tissue (paraffin block from original biopsy) will be collected for research purposes.

Arms: arm 1: RAD001 (Everolimus)10 mg by mouth daily without interruption
Interventions: intervention 1: RAD001 (everolimus)
Intervention descriptions: intervention 1: 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities

Protocol documents:
Clinical trial NCT00416182
Conditions: Sinusitis Cystic Fibrosis
Keywords: Cystic fibrosis chronic sinusitis mucolytic
Sponsor: University of Vermont
Start date: 2006-12-01; Completion date: 2012-06-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.

Detailed description:
AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis (CF)

PROCEDURES: 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months. Consent will be obtained following surgery and treatment will begin 1 week post-operatively.

Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 2.5, 6, 9 and 12 months.

Outcome measures will include ciliary function testing, pulmonary function testing, sinus questionnaires and CT scan.

Arms: arm 1: 2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily arm 2: 2.5 mg/2mL placebo administered intranasally once daily
Interventions: intervention 1: Pulmozyme (dornase alfa) intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device intervention 2: 2.5 mL of placebo delivered via Sinustar nebulizer device

Protocol documents:
Clinical trial NCT00429299
Conditions: Neoplasms, Breast
Keywords: neo-adjuvant trastuzumab early breast cancer lapatinib
Sponsor: GlaxoSmithKline
Start date: 2006-08-01; Completion date: 2012-06-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.

Detailed description:

Arms: arm 1: Chemotherapy plus trastuzumab arm 2: Chemotherapy plus lapatinib arm 3: Chemotherapy plus trastuzumab plus lapatinib
Interventions: intervention 1: lapatinib intervention 2: trastuzumab intervention 3: paclitaxel intervention 4: fluorouracil intervention 5: epidoxorubicin intervention 6: cyclophosphamide
Intervention descriptions: intervention 1: Arm B 1250mg/d PO Arm C 750mg/d PO intervention 2: First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins intervention 3: 80mg/sqm 1 hour infusion for 12 weeks intervention 4: 600mg/sqm iv day 1 q21 days for four coursess intervention 5: 75mg/sqm iv day 1 q21 days for four courses intervention 6: 600mg/sqm day 1 q21 days for four courses

Protocol documents: