ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00338949
Conditions: Schizophrenia Metabolic Syndrome X Insulin Resistance
Keywords: Ziprasidone Olanzapine Risperidone Schizoaffective Disorder Insulin Sensitivity Visceral Adiposity Metabolic Syndrome
Sponsor: Veterans Medical Research Foundation
Start date: 2006-06-01; Completion date: 2009-12-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.

Detailed description:
People with schizophrenia often lead more sedentary lifestyles than people without the disease, and they are frequently treated with antipsychotic medications that cause weight gain. Combined, these factors produce an increased risk for metabolic syndrome, which can lead to heart disease and type 2 diabetes. Characteristics of metabolic syndrome include carrying excess weight around the abdominal region; high blood pressure; high blood sugar levels; high levels of fat in the blood; and low levels of HDL cholesterol. Recent studies have shown that certain atypical antipsychotic drugs are relatively weight-neutral. Switching from a drug that promotes weight gain to a weight-neutral medication, such as ziprasidone, may result in significant weight loss. There is insufficient evidence, however, demonstrating the extent of improvement in insulin sensitivity after switching medications. This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.

Participants in this open label study will currently be undergoing treatment with risperidone or olanzapine at the time of study entry. Upon study entry, they will be randomly assigned to either switch to ziprasidone treatment or remain on their current medications. Both groups will be treated for 26 weeks. Participants will report to the study site for evaluations biweekly until week 10 and then monthly for the duration of the study. The primary outcomes at Week 26 will be: change from baseline in insulin sensitivity, using an intravenous glucose tolerance test; change from baseline in ivisceral fat mass, using a CT scan.

Arms: arm 1: Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone arm 2: Participants who enter on risperidone or olanzapine and switch to ziprasidone
Interventions: intervention 1: Switch intervention 2: Control
Intervention descriptions: intervention 1: Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects. intervention 2: Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.

Protocol documents:
Clinical trial NCT00350727
Conditions: Glioma
Keywords: relapsed lapatinib Pazopanib glioblastoma
Sponsor: GlaxoSmithKline
Start date: 2006-12-01; Completion date: 2009-12-01
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas.

Detailed description:
This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas.

Arms: arm 1: Pazopanib and Lapatinib in combination. Subjects remain on treatment until disease progression or withdrawal from study.
Interventions: intervention 1: pazopanib intervention 2: lapatinib
Intervention descriptions: intervention 1: Pazopanib is a novel compound being developed for the treatment of various cancers. intervention 2: Lapatinib is a novel compound being developed for the treatment of various cancers.

Protocol documents:
Clinical trial NCT00364819
Conditions: Primary Biliary Cirrhosis
Keywords: Primary Biliary Cirrhosis
Sponsor: University of California, Davis
Start date: 2007-01-01; Completion date: 2009-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with PBC, a disease of the immune system. However, the safety of rituximab in PBC patients must first be established.

Detailed description:
This is a pilot, open-label, study on 10 female patients with AMA-positive PBC to determine the effects of two infusions of rituximab on response of memory B cells to bacterial motifs, on biochemical function, and histological features. We will enroll 10 consecutive AMA-positive patients with the diagnosis of PBC based on internationally accepted criteria and histological staging determined at liver biopsy and being currently treated with UDCA. Importantly, patients with advanced histological stages, decompensated liver disease, or waiting for OLT will not be included in the study (see exclusion criteria).

Patients eligible and willing to enter the study will be evaluated at baseline by isolation and study of frequency and absolute numbers of B cells and their function, biochemical and AMA tests. Histology and quality of life will be also evaluated in all patients. The methodology to be used for B cell study is already well-established in our laboratory as can be seen in the attached paper (Kikuchi et al. 2005b). Patients will be administered 1,000 mg rituximab intravenously by slow infusion on Day 1 and Day 15 (+/- 1 day). Rituximab's pharmacokinetics indicate that complete B cell depletion is obtained 2-3 days after administration and that such effect may be lost after 9 months (Vieira et al. 2004). In addition to our B cell work, serum samples will undergo AMA testing, including titers, using recombinant mitochondrial antigens (Miyakawa et al. 2001). Patients will also undergo serum chemistry panel, which includes liver function tests. Patients will continue on a steady dose of UDCA therapy throughout the study.

Arms: arm 1: rituximab 1000 mg IV on days 1 and 15, given over 5 - 6 hours
Interventions: intervention 1: rituximab
Intervention descriptions: intervention 1: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours

Protocol documents:
Clinical trial NCT00365261
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: pain fatigue sleep bone marrow transplant cancer
Sponsor: University of California, San Diego
Start date: 2006-09-01; Completion date: 2009-12-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:

* improve sleep thereby decreasing need for opiates via PCA
* improve sleep thereby decreasing pain by self report
* improve sleep thereby decreasing fatigue by self report

Detailed description:
Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms of pain and fatigue.

One of the less commonly recognized side effects of opiate use is sleep disruption.

Experimentally-induced sleep disruption lowers the threshold for detection of painful stimuli. Thus, although opiates are obviously helpful for pain, they do so at certain "costs": they increase next day fatigue, constipation, and have other side effects; they disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep disruptive properties, they lower the threshold for pain stimuli.

Cancer patients requiring chemotherapy commonly require PCA because of oral mucositis. The objective of this study is to assess whether opiate usage may be reduced and complaints of fatigue and pain be lessened if patients had better sleep.

Arms: arm 1: active drug arm 2: placebo
Interventions: intervention 1: Eszopiclone intervention 2: Placebo
Intervention descriptions: intervention 1: eszopiclone 2 to 3 mg po at bedtime intervention 2: placebo 2 to 3 mg po at bedtime

Protocol documents:
Clinical trial NCT00368550
Conditions: Alcoholism
Keywords: Alcohol Drinking Alcohol Dependence Sertraline Pharmacotherapy Alcoholism Subtypes Early- versus Late-Onset Alcoholism
Sponsor: UConn Health
Start date: 2004-02-01; Completion date: 2009-12-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment period.

Detailed description:
In an effort to broaden the options for pharmacotherapy of alcoholism, this study will examine the effects of sertraline, a selective serotonin reuptake inhibitor (SSRI), for the treatment of alcohol dependence. The study is based on evidence that, although SSRI therapy is not appropriate for all alcoholics, there exists a substantial subgroup of alcoholics for whom SSRIs appear to exert a clinically important effect. Sertraline is among the most widely prescribed psychotropic medications in the world. Consequently, this study will examine the safety and efficacy of sertraline, the mechanism and duration of those effects and the best method for subtyping alcoholics to identify individuals for whom the medication is most likely to produce a clinically important reduction in drinking behavior.

The study employs a parallel-group, prospective design in which randomization is balanced on patient subtype (early-onset/late-onset) and other relevant pretreatment measures with an approximately equal number of subjects assigned to treatment with sertraline (to a maximum of 200 mg/day) or placebo. The study will include a 14-week treatment period; because the 2 weeks are for medication taper, efficacy will be evaluated over the first 12 treatment weeks. A total of 160 early-onset or late-onset alcoholics will be randomized. Daily process measures of positive and negative events, global perceived stress, mood, desire to drink, and drinking frequency and intensity, collected using interactive voice response technology, will provide insight into the mechanisms by which sertraline may exert its effects. Coping-skills training will be provided weekly for the first 6 weeks, then every other week for the last 8 weeks of the study. A 6-month post-treatment follow-up period will evaluate the duration of medication effects. This study will also examine the relation between genotypes at a number of relevant loci and both risk of alcohol dependence and response to sertraline treatment.

Arms: arm 1: Oral sertraline, cognitive-behavioral counseling to maintain abstinence from alcohol arm 2: Placebo, cognitive-behavioral counseling to maintain abstinence from alcohol
Interventions: intervention 1: Sertraline intervention 2: Placebo
Intervention descriptions: intervention 1: Sertraline (to a maximum of 200 mg/day) for 14-week treatment period intervention 2: Placebo for 14-week treatment period

Protocol documents:
Clinical trial NCT00372775
Conditions: Non-Small Cell Lung Cancer
Keywords: brain metastases Sunitinib Phase 2
Sponsor: Pfizer
Start date: 2007-03-01; Completion date: 2009-12-01
Enrollment: 66 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00374907
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2006-09-01; Completion date: 2009-12-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

Detailed description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Arms: arm 1: Metformin 500-1500 mg (open-label, as needed for rescue in LT) arm 2: Metformin 500-1500 mg (open-label, as needed for rescue in LT)
Interventions: intervention 1: Saxagliptin intervention 2: Placebo intervention 3: Metformin (blinded) intervention 4: Metformin (open-label)
Intervention descriptions: intervention 1: Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT) intervention 2: Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST) intervention 3: Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12) intervention 4: Tablets, Oral, 500-1500 mg, as needed (starting in LT)

Protocol documents:
Clinical trial NCT00385203
Conditions: Gastrointestinal Stromal Tumors Soft Tissue Sarcomas
Keywords: cancer tumour advanced cancer Metastatic Gastro-Intestinal Stromal Tumours gastro-intestinal cancer RECENTIN
Sponsor: AstraZeneca
Start date: 2006-09-01; Completion date: 2009-12-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue Sarcoma (STS) resistant to standard therapy.

Detailed description:

Interventions: intervention 1: AZD2171
Intervention descriptions: intervention 1: 45 mg oral tablet once daily dose

Protocol documents:
Clinical trial NCT00402116
Conditions: Glioblastoma Glioblastoma Multiforme Gliosarcoma
Sponsor: Eli Lilly and Company
Start date: 2006-09-01; Completion date: 2009-12-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study.

The first phase of this study is done to evaluate the safety of enzastaurin in patients. This is done by gradually increasing the dose of the drug in small groups of patients and watching closely for side effects.

In the second phase of the study, the dose determined to be safe will be used with temozolomide during and following radiation therapy to see if the combination can help patients with brain tumors live longer.

Detailed description:

Arms: arm 1: The Phase 1 consisted of the dose escalation of enzastaurin in 2 cohorts of up to 6 patients to assess maximum tolerated dose (MTD). Cohort 1 = radiotherapy/enzastaurin 250 mg per day/temozolomide 75 mg/m\^2 therapy. The 6 initial cohort patients were clinically evaluated for dose-limiting toxicities (DLT). If no more than 1 of 6 patients experienced a DLT or tumor progression, patients continued 1 complete adjuvant enzastaurin/temozolomide 28-day cycle. If there was no significant toxicity after the first adjuvant cycle, participants received subsequent adjuvant enzastaurin/temozolomide cycles. If no more than 1 of the 6 initial cohort participants treated at 250 mg of enzastaurin experienced a DLT during radiotherapy and the first adjuvant cycle, up to 6 more participants could be entered at 500 mg of enzastaurin. The Phase 2, using the MTD determined in the Phase 1 (250 mg), evaluated the combination's safety and measured OS.
Interventions: intervention 1: enzastaurin intervention 2: temozolomide intervention 3: radiation therapy
Intervention descriptions: intervention 1: Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles

Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles intervention 2: 75 milligrams per meter squared (mg/m\^2), oral, daily, 6 weeks then 200 mg/m\^2, oral, daily, twelve 28 day cycles intervention 3: 1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks

Protocol documents:
Clinical trial NCT00410891
Conditions: Intravitreous Injections
Sponsor: Stanford University
Start date: 2008-07-01; Completion date: 2009-12-01
Enrollment: 129 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluation of efficacy of topical preoperative antibiotics in patients undergoing intravitreous injections.

Detailed description:

Arms: arm 1: topical gatifloxacin 4 times per day
Interventions: intervention 1: gatifloxacin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00411762
Conditions: Pancreatic Cancer
Keywords: Pancreatic
Sponsor: Yale University
Start date: 2006-12-01; Completion date: 2009-12-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this research project is to determine the amount of capecitabine (Xeloda) which can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the aim of this research project to determine what the effects, good and/or bad, are of combining capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of advanced pancreatic cancer.

PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906 has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for hundreds of years.

The other drug involved in this study, capecitabine is an oral form of chemotherapy already approved by FDA in the management of colorectal and breast cancer.

Laboratory studies in animal models have shown that the combination of capecitabine and PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this combination in patients with liver cancer to define the benefit. PHY906 has also shown to decrease diarrhea related to chemotherapy in a small study performed in patients with colon cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models. This prompted us to test the combination of capecitabine and PHY906 in patients with advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side effects, such as diarrhea caused by capecitabine.

Detailed description:

Arms: arm 1: PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle
Interventions: intervention 1: Capecitabine intervention 2: PHY906
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00412217
Conditions: Head and Neck Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-11-01; Completion date: 2009-12-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.

Detailed description:

Arms: arm 1: Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity. arm 2: Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
Interventions: intervention 1: Placebo intervention 2: Erlotinib intervention 3: Standard of care
Intervention descriptions: intervention 1: Participants will receive placebo tablets (matched to erlotinib) once daily. intervention 2: Erlotinib will be given as 150 mg PO once daily. intervention 3: Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.

Protocol documents: