ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00539513
Conditions: Obsessive-Compulsive Disorder
Keywords: obsessive-compulsive disorder OCD glutamate N-Acetylcysteine augmentation
Sponsor: Yale University
Start date: 2006-06-01; Completion date: 2011-04-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal of suffering. Many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established therapeutic strategies. New avenues of treatment are urgently needed.

Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin or dopamine; but increasing evidence suggests that functional disruptions of a different neurotransmitter, glutamate, may contribute to some cases of OCD. The researchers are therefore interested in using medications that target glutamate as novel treatment options for those OCD patients who do not benefit from established treatments.

One such medication is the drug N-Acetylcysteine, whose glutamatergic antagonistic properties may be effective in reducing the glutamatergic hyperactivity that is thought to contribute to the pathophysiology of OCD and major depressive disorder (MDD).

Riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) is also a glutamatergic agent. There is evidence that riluzole possesses anti-depressant, anti-obsessional, and anti-anxiety properties.

The modulation of glutamatergic activity is a promising new approach to the treatment of mood disorders. The researchers are therefore now recruiting patients to participate in a double-blind, placebo-controlled trial of N-Acetylcysteine, added to whatever other OCD medications they are taking.

Detailed description:
Due to limited participation, this study has closed.

Arms: arm 1: Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment arm 2: Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Interventions: intervention 1: N-Acetylcysteine intervention 2: placebo
Intervention descriptions: intervention 1: 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks intervention 2: placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks

Protocol documents:
Clinical trial NCT00544167
Conditions: Breast Cancer
Keywords: Breast Cancer Early Stage High Risk Node Positive Doxorubicin Cyclophosphamide Paclitaxel Sorafenib
Sponsor: SCRI Development Innovations, LLC
Start date: 2007-05-01; Completion date: 2011-04-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Sorafenib is being looked at in a number of solid tumor settings including breast cancer. This trial is designed as a pilot study to assess the safety and tolerability of a novel oral agent in combination with standard chemotherapy in the treatment of early stage node positive or otherwise high-risk breast cancer. If this should prove to be a tolerable regimen for patients, this would provide rationale for further studies in a larger randomized fashion.

Detailed description:
Primary Objectives The primary objective is to assess the safety and tolerability of doxorubicin / cyclophosphamide followed by paclitaxel in combination with sorafenib in patients with early stage node positive or otherwise high-risk breast cancer.

Secondary Objectives The secondary objectives are to assess activity in the form of recurrence-free-interval, distant recurrence-free interval,and overall survival in this pilot study of doxorubicin / cyclophosphamide followed by paclitaxel in combination with sorafenib in patients with early stage node positive or otherwise high-risk breast cancer.

Arms: arm 1: All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
Interventions: intervention 1: Doxorubicin intervention 2: Cyclophosphamide intervention 3: Paclitaxel intervention 4: Sorafenib
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00554840
Conditions: Cigarette Smoking Schizophrenia
Sponsor: University of Maryland, Baltimore
Start date: 2007-11-01; Completion date: 2011-04-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.

Detailed description:
The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of \< 30 ng/ml. The primary endpoint will be point prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. The point prevalence abstinence rates will also be obtained. The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. intervention 2: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.

Protocol documents:
Clinical trial NCT00557830
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma Kidney Cancer
Sponsor: Accelerated Community Oncology Research Network
Start date: 2008-01-01; Completion date: 2011-04-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to compare the effectiveness of a dose-escalation regimen (400 to 800mg bid) relative to the standard dosing regimen (400mg bid) of sorafenib given in patients with metastatic RCC.

The secondary objectives are to evaluate the effects of the dose-escalation regimen on the quality of life (QoL) of patients with metastatic RCC and to characterize the safety and tolerability profile of a dose-escalation regimen of sorafenib in patients with metastatic RCC.

Detailed description:

Arms: arm 1: Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12. arm 2: Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Interventions: intervention 1: Sorafenib Escalated Dose intervention 2: Sorafenib Standard Dose
Intervention descriptions: intervention 1: Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12. intervention 2: Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.

Protocol documents:
Clinical trial NCT00562965
Conditions: Lymphoma, Follicular
Sponsor: Pfizer
Start date: 2007-11-01; Completion date: 2011-04-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.

Detailed description:
On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment.

Arms: arm 1: Subjects will receive rituximab intravenously at a dose level of 375 mg/m² on day 1 of each cycle followed by inotuzumab ozogamicin administered intravenously at a dose level of 1.8 mg/m2 on day 2. The sequence will be repeated every 28 days. arm 2: Subjects will receive the investigator's choice from the following rituximab-containing regimens: R-CVP or R-FND. The investigator's choice of therapy will be administered every 21 days. Dosing for R-CVP will be intravenous rituximab at a dose of 375 mg/m2 on day 1, intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1, intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1, and oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5. Dosing for R-FND will be as follows: rituximab 375 mg/m2 intravenous on day 1, mitoxantrone 10 mg/m2 intravenous on day 2, fludarabine 25 mg/m2 intravenous on days 2 through 4 and oral dexamethasone 20 mg/day on days 1-5.
Interventions: intervention 1: inotuzumab ozogamicin intervention 2: rituximab intervention 3: rituximab intervention 4: cyclophosphamide intervention 5: vincristine intervention 6: prednisone/prednisolone intervention 7: mitoxantrone intervention 8: fludarabine intervention 9: dexamethasone
Intervention descriptions: intervention 1: IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles. intervention 2: IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles. intervention 3: intravenous rituximab at a dose of 375 mg/m2 on day 1 intervention 4: intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1 intervention 5: intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1 intervention 6: oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5 intervention 7: mitoxantrone 10 mg/m2 intravenous on day 2 intervention 8: fludarabine 25 mg/m2 intravenous on days 2 through 4 intervention 9: oral dexamethasone 20 mg/day on days 1-5

Protocol documents:
Clinical trial NCT00588471
Conditions: Coronary Artery Disease
Sponsor: Mayo Clinic
Start date: 2002-11-01; Completion date: 2011-04-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to determine if one dose of simvastatin will decrease the inflammatory response to coronary intervention. Also to determine if one dose of simvastatin affects endothelial function (activity of the artery) as measured by noninvasive peripheral artery tonography.

Detailed description:
The objective of this study is to determine if acute pretreatment with simvastatin, an HMG-CoA reductase inhibitor will reduce the post inflammatory response after percutaneous coronary interventions (PCI), and/or change endothelial function as assessed by peripheral arterial tomography (PAT). Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.

Patients will be pretreated with simvastatin 80 mg prior to undergoing PCI. Endothelial function will be assessed before and after treatment via PAT. Our working hypothesis is patients pretreated with simvastatin, will have 1) attenuated inflammatory response, as noted by decreased levels of serum high sensitivity CRP and IL-6 and 2) improved endothelial function as compared to patients not pretreated with statin therapy.

Arms: arm 1: Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention. arm 2: Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention. intervention 2: Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.

Protocol documents:
Clinical trial NCT00597597
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer ER and PR hormone receptor negative HER2/neu negative EGFR positive
Sponsor: Rush University Medical Center
Start date: 2007-04-01; Completion date: 2011-04-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. If erlotinib is shown to have activity, this could identify a form of targeted therapy for this specific subset of breast cancer patients. In addition, it may identify a subset of breast cancer patients with tumors that overexpress EGFR in whom other EGFR targeted therapies could warrant further testing.

Detailed description:
This is a Phase II, open-label, single institution trial of treatment with single agent erlotinib. The purpose of the research is to determine the effects erlotinib has on the breast cancer tumors in women with metastatic hormone receptor negative and HER2-negative breast cancer. The Federal Drug Administration (FDA) has approved erlotinib, also known as Tarceva, for the treatment of locally advanced and metastatic non-small cell lung cancer.

To qualify for the trial, subjects must have histologically confirmed, incurable, locally advanced or metastatic breast cancer that is ER-negative, PR-negative, Her2/neu-negative and EGFR-positive. Subjects must have measurable disease. They must have received less than or equal to 1 chemotherapeutic agent in the metastatic setting. The target accrual is 43 subjects. Initially, 18 subjects will be accrued. If at least 3 subjects are progression-free at 4 months, accrual will continue to a maximum of 43 subjects. Subject eligibility will be evaluated during a screening period of 4 weeks. During the treatment period, subjects will receive single agent erlotinib, 150mg/day. Subjects will receive the first dose of erlotinib on Day 0, within 7 days of registration. Efficacy will be assessed by radiographic tumor assessment or photographic documentation. Safety will be assessed by the recording of adverse events and laboratory test results. Subjects with documented progressive disease will be discontinued from treatment and will be followed for survival information every 2 months until death, lost to follow-up or study termination.

Arms: arm 1: Open label; In this open label study, all enrolled subjects receive active drug, Erlotinib
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: During the treatment period, subjects will receive single agent erlotinib, 150mg/day.

Protocol documents:
Clinical trial NCT00597896
Conditions: Bipolar Disorder
Sponsor: Northwell Health
Start date: 2005-10-01; Completion date: 2011-04-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be able to improve cognitive problems (i.e. difficulties with thinking, memory, and concentration) that may be associated with bipolar disorder.

Detailed description:
To address the primary aim, the study is an eight-week, randomized, double-blind, placebo-controlled treatment trial of pramipexole in 50 euthymic bipolar I and II disorder (BPD) patients, who demonstrate cognitive impairment.

Arms: arm 1: Day 1: Random assignment to drug or placebo and dosage starting at 0.125 mg BID, which will be increased every week to a target dose of 1.5 mg/day. Targeted maximum dose of 1.5 mg/day is expected to be reached by week 4, however, dosing will be flexible based upon side effects reported. The maximum dose will be 1.5 mg/day. arm 2: Day 1: Random assignment to drug or placebo and dosage starting at 0.125 mg BID, which will be increased every week to a target dose of 1.5 mg/day. Targeted maximum dose of 1.5 mg/day is expected to be reached by week 4, however, dosing will be flexible based upon side effects reported. The maximum dose will be 1.5 mg/day.
Interventions: intervention 1: pramipexole
Intervention descriptions: intervention 1: po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid

Protocol documents:
Clinical trial NCT00603915
Conditions: Nasopharyngeal Cancer
Keywords: gemcitabine carboplatin cisplatin erlotinib tarceva nasopharyngeal
Sponsor: University Health Network, Toronto
Start date: 2006-06-01; Completion date: 2011-04-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles; Gemcitabine will be given on day 1 and day 8 every 21 days for 6 cycles. Those patients that do not progress on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease progression. A cycle of erlotinib will be 28 days. Patients who progress on GC will be offered erlotinib as well,in order to evaluate its activity as a single-agent in the second-line setting.

Patients previously treated with GC have reported a progression-free survival (PFS) of 9 months. We would anticipate an extension of PFS to 12 months in patients treated with GC followed by maintenance erlotinib. Furthermore, we hypothesize that patients who achieved benefit from GC therapy would have further response when treated with maintenance erlotinib, such that this strategy may increase the likelihood of attaining long-term survival.

Detailed description:

Arms: arm 1: Eligible patients are treated with cisplatin/carboplatin and gemcitabine (GC) for 6 cycles of therapy followed by maintenance erlotinib. Those patients achieving SD or PR with chemotherapy will be started on maintenance erlotinib until disease progression. Those patients achieving CR with chemotherapy will be started on erlotinib for 6 cycles of treatment and those achieving CR on erlotinib will be treated with a maximum of 6 further cycles of erlotinib. Those patients with disease progression while on chemotherapy will be offered erlotinib 2 weeks following the last dose of chemotherapy until further disease progression.
Interventions: intervention 1: Gemcitabine intervention 2: Carboplatin/Cisplatin intervention 3: erlotinib
Intervention descriptions: intervention 1: 1000mg/m\^2 intravenous (IV) day 1 and day 8 intervention 2: Area under curve (AUC)=5 (Carboplatin) or 70mg/m\^2 (Cisplatin) intravenous (IV) day 1 intervention 3: 150mg daily (post GC therapy)

Protocol documents:
Clinical trial NCT00626782
Conditions: Glaucoma
Keywords: glaucoma glucoma filtering surgery ranibizumab mitomycin C patients requiring first time glaucoma filtering surgery
Sponsor: Wills Eye
Start date: 2008-01-01; Completion date: 2011-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.

Detailed description:
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied.

Post operative follow-up will consist of a minimum of 6 visits during a one year period.

Arms: arm 1: Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent. arm 2: Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.
Interventions: intervention 1: Ranibizumab intervention 2: Mitomycin (MMC)
Intervention descriptions: intervention 1: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery intervention 2: Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.

Protocol documents: