ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00481845
Conditions: Breast Cancer
Sponsor: Stanford University
Start date: 2008-01-01; Completion date: 2009-12-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study we plan to study the combination of ZD6474, a dual inhibitor of EGFR and VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast cancer. The aim is to overcome mechanisms of resistance and simultaneously block multiple critical signaling pathways known to stimulate breast cancer.

Detailed description:
The use of adjuvant chemotherapy and endocrine therapy has had a significant impact on breast cancer survival. However, not all patients will benefit from each of these therapies. Increasing data suggests that patients with hormone receptor-positive breast cancer derive marginal benefit from the addition of adjuvant chemotherapy. Identification and characterization of cellular signaling pathways active in the pathogenesis of breast cancer has lead to the development of multiple targeted therapies that hold enormous promise for patients with less toxicity than conventional chemotherapy. Treatment strategies employing neoadjuvant therapy have found that pCR is predictive for ultimate outcome. Due to this, the use of neoadjuvant therapy has become an intense area of investigation in operable breast cancer. In the IMPACT trial, the aromatase inhibitor anastrozole was found to improve eligibility for breast conservation and was associated with a favorable clinical objective response after 12 weeks of therapy.

In this proposed study, we plan to study the combination of ZD6474, a dual inhibitor of EGFR and VEGFR-2, with anastrozole in the neoadjuvant setting for patients with Stage I-III breast cancer. The aim is to overcome mechanisms of resistance and simultaneously block multiple critical signaling pathways known to stimulate breast cancer. The two agents have non-overlapping toxicities and are both administered orally, allowing for a more tolerable treatment regimen. By using this combination in the neoadjuvant setting, we will target the critical signaling pathways early and follow tumor responses during therapy, allowing for prompt evaluation of the effectiveness of this treatment strategy. Pathologic tumor specimens obtained at the time of definitive surgery will be evaluated for pathologic complete response thus adding to the body of literature. By examining molecular markers such as ER, PR, EGFR, and Ki-67 pre- and post-treatment, we hope to correlate modulations in these biomarkers to response. Finally, using a novel second generation functional breast MRI we will investigate the ability of MRI to predict response to antiangiogenic therapy.

Arms: arm 1: Vandetanib and Anastrozole as neoadjuvant therapy arm 2: Anastrozole as neoadjuvant therapy
Interventions: intervention 1: Vandetanib intervention 2: Anastrozole
Intervention descriptions: intervention 1: 300 mg daily intervention 2: 1 mg daily

Protocol documents:
Clinical trial NCT00485069
Conditions: Parkinson Disease Parkinson's Disease
Keywords: Ropinirole hydrochloride L-dopa Parkinson's Disease Dopamine agonist
Sponsor: GlaxoSmithKline
Start date: 2007-06-01; Completion date: 2009-12-01
Enrollment: 123 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006.

ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at \>10mg/day is limited.

For this reason, this study was designed as a multicenter open-label uncontrolled study.

This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn \& Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ROP intervention 2: ROP+L-Dopa
Intervention descriptions: intervention 1: Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. Concomitant use of L-dopa is prohibited during the study. intervention 2: Ropinirole Hydrochloride with L-Dopa adjunct therapy group (ROP+L-Dopa): Patients will receive ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 milligrams (mg)/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. The dosing regimen of L-dopa remain unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.

Protocol documents:
Clinical trial NCT00485836
Conditions: Macular Edema Retinal Vein Occlusion
Keywords: CRVO RVO Lucentis Edema
Sponsor: Genentech, Inc.
Start date: 2007-07-01; Completion date: 2009-12-01
Enrollment: 392 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to central retinal vein occlusion (CRVO); 392 patients with CRVO were enrolled at 95 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Sham injection intervention 2: Ranibizumab injection 0.3 mg intervention 3: Ranibizumab injection 0.5 mg
Intervention descriptions: intervention 1: Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections. intervention 2: Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. intervention 3: Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.

Protocol documents:
Clinical trial NCT00504712
Conditions: Hypogonadism Peripheral Vascular Disease Type 2 Diabetes
Keywords: Testosterone Hypogonadism Diabetes PVD RCT
Sponsor: Barnsley Hospital
Start date: 2006-02-01; Completion date: 2009-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.

Detailed description:
Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.

Arms: arm 1: Testosterone 200 mg intramuscular every 2 weeks arm 2: Saline
Interventions: intervention 1: Testosterone intervention 2: saline
Intervention descriptions: intervention 1: Sustanon- 200mg- Intramuscular testosterone every 2 weeks intervention 2: Saline injection every two weeks

Protocol documents:
Clinical trial NCT00513305
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia, cytarabine, arsenic trioxide.
Sponsor: Cephalon
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.

Detailed description:

Arms: arm 1: Cycle 1 cytarabine 10 mg/m\^2 was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2 A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m\^2 sc bid on days 1 through 7 of a 28-day cycle. arm 2: Cytarabine was administered at a dose of 10 mg/m\^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine was given to patients with persistent disease. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. Recovery period up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m\^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
Interventions: intervention 1: Arsenic trioxide intervention 2: Low-dose cytarabine alone
Intervention descriptions: intervention 1: Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg. intervention 2: Cytarabine will be administered at a dose of 10 mg/m\^2 subcutaneously (sc) twice a day (bid).

Protocol documents:
Clinical trial NCT00522457
Conditions: Metastatic Breast Cancer Advanced Breast Cancer
Keywords: Breast Cancer investigational drug drug therapy Antineoplastic Protocols Immunotherapy Metastatic breast cancer Advanced breast cancer Stage IV breast cancer Her-2/neu expressing breast cancer Her-2/neu Trastuzumab refractory
Sponsor: Neovii Biotech
Start date: 2008-01-01; Completion date: 2009-12-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu) overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test result) metastatic breast cancer progressing after trastuzumab treatment.

Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory immune effector cells (e.g. macrophages, dendritic cells \[DCs\] and natural killer \[NK\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.

Detailed description:
This study is an open-label, non-randomized, uncontrolled, two-stage phase II study evaluating the efficacy and safety of ertumaxomab. Ertumaxomab will be administered three times at 7 day intervals by constant rate 3 hour intravenous (i.v.) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7 ± 1 day) and 100 µg (day 14 ± 1 day) (flat doses).

Interventions: intervention 1: ertumaxomab
Intervention descriptions: intervention 1: Ertumaxomab will be intravenously administered to see if it can increase the patient's objective response rate.

Protocol documents:
Clinical trial NCT00527332
Conditions: Hysterectomy (MeSH nr: E04.950.300.399)
Keywords: Hospitalization Postoperative care Quality of Life Health economy Anesthesia. Spinal Anesthesia, General
Sponsor: Preben Kjolhede
Start date: 2007-03-01; Completion date: 2009-12-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.

Detailed description:

Arms: arm 1: Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol. arm 2: General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
Interventions: intervention 1: Bupivacain intervention 2: Morphine intervention 3: Propofol intervention 4: Propofol intervention 5: Fentanyl intervention 6: Rocuronbromid intervention 7: Morphine
Intervention descriptions: intervention 1: 5 mg/mL, 4 mL intrathecally as a single dos intervention 2: 0.4 mg/mL; 0.5 mL intrathecally as a single dosage intervention 3: 2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery intervention 4: Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery intervention 5: 100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery. intervention 6: 0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery intervention 7: 5 mg is given IV (intravenously) before end of surgery

Protocol documents:
Clinical trial NCT00529386
Conditions: Prostatitis Chronic Pain Syndrome
Keywords: prostatitis Botox
Sponsor: Queen's University
Start date: 2006-01-01; Completion date: 2009-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety and efficacy of intraprostatic injection of Botox for the treatment of men diagnosed with chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS).

Detailed description:
This is a prospective open label study examining the efficacy and safety of intraprostatic Botox . Men with a clinical diagnosis of chronic nonbacterial prostatitis/CPPS will be treated with intraprostatic Botox™ and followed for 12 weeks (primary efficacy analyses), and 24 weeks (long term follow-up) for responders.

It is proposed that a total of 40 males will be enrolled. There will be seven (7) research clinic visits and two phone contacts: Visit 1 (screening), Visit 2 (baseline/treatment), Visit 3 (2-week safety evaluation - clinic contact), Visit 4 (4-week safety evaluation - phone contact), Visit 5 (6-week interim efficacy/safety), Visit 6 (12-week primary endpoint evaluation), Visit 7 (14-week clinic follow up), Visit 8 (16 week phone contact) and Visit 9 (24-week clinic close out).

Outcome measures include Chronic Prostatitis Symptom Index (CPSI 0-35), NRS pain (0-10), Global Response Assessment (GRA) at 12 weeks. Safety to be monitored during the study.

Arms: arm 1: 300 IU botox
Interventions: intervention 1: Botox
Intervention descriptions: intervention 1: 300 units

Protocol documents:
Clinical trial NCT00535652
Conditions: Diverticulosis, Colonic Rectal Neoplasms Colonic Neoplasms
Sponsor: University of Ulm
Start date: 2007-09-01; Completion date: 2009-12-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.

Detailed description:
The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.

Arms: arm 1: Administration of 1 gram ertapenem I.V.
Interventions: intervention 1: Ertapenem
Intervention descriptions: intervention 1: powder for infusion, 1 gram I.V., single dose over 30 min.

Protocol documents:
Clinical trial NCT00537485
Conditions: Early Parkinson's Disease
Keywords: SPM 962 rotigotine Parkinson's disease monotherapy
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2007-09-01; Completion date: 2009-12-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPM 962 intervention 2: placebo
Intervention descriptions: intervention 1: transdermal application, 1 time per day intervention 2: transdermal application, 1 time per day

Protocol documents:
Clinical trial NCT00545545
Conditions: Recurrent Colorectal Carcinoma Progressive Colorectal Carcinoma
Keywords: Colorectal Carcinoma Recurrent Progressive Cetuximab Irinotecan 5-Fluorouracil
Sponsor: HiberCell, Inc.
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.

Detailed description:

Arms: arm 1: Treatment Arm 1 2.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. arm 2: Treatment Arm 1 4.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. arm 3: Treatment Arm 1 6.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. arm 4: Treatment Arm 2 2.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab. arm 5: Treatment Arm 2 4.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab. arm 6: Treatment Arm 2 6.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Interventions: intervention 1: Imprime PGG 2 mg/kg intervention 2: Imprime PGG 4 mg/kg intervention 3: Cetuximab intervention 4: Irinotecan intervention 5: Imprime PGG 6mg/kg
Intervention descriptions: intervention 1: Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops. intervention 2: Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops. intervention 3: Infusion 400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle; intervention 4: Infusion 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle intervention 5: Infusion of 6mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.

Protocol documents:
Clinical trial NCT00546117
Conditions: Otitis Media With Effusion
Keywords: otitis media with effusion gastroesophageal reflux ear infection proton pump inhibitor
Sponsor: Washington University School of Medicine
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.

Detailed description:
This study is being done to see if reflux of stomach fluid might be a cause of fluid in the ears. Earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the middle ear fluid of many children with chronic middle ear fluid. Anti-reflux medicines called proton pump inhibitors (PPI) reduce the acidity of the contents of the stomach and the activity of pepsin or pepsinogen. We are studying the effectiveness of a PPI called lansoprazole (Prevacid™) in reducing fluid in the ears. If lansoprazole is able to reduce the fluid in the middle ear, this tells us that the reflux of gastric acid into the esophagus and into the ear canal may be causing middle ear fluid.

Arms: arm 1: Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months arm 2: Placebo SoluTab once daily for 2 months
Interventions: intervention 1: lansoprazole intervention 2: placebo
Intervention descriptions: intervention 1: Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing \>30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm. intervention 2: Placebo Solutab in 15 and 30 mg dosages.

Protocol documents:
Clinical trial NCT00546481
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-11-01; Completion date: 2009-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] intervention 2: Epoetin
Intervention descriptions: intervention 1: 0.6 micrograms/kg every 2 weeks intervention 2: As prescribed, iv, 3 times weekly

Protocol documents: